Search Results for "Fillers and Injectables"
Cosmetic Complications: Rare and Serious Events Following Botulinum Toxin and Soft Tissue Filler Administration
Eric P. Sorensen BSa,b and Christine Urman MDb| |
OBJECTIVE: This article aims to review the rare but serious complications associated with the injectables used in cosmetic dermatology, and the pathogenesis, diagnosis, and management of each.
METHODS AND MATERIALS: A literature review for case reports pertaining to rare adverse events following botulinum toxin or soft tissue fillers was performed using the MEDLINE database.
RESULTS: Complications of BTX included dry eye syndrome, strabismus and diplopia, superficial temporal artery pseudoaneurysm, neck weakness, hoarseness, and dysphagia. Complications associated with soft tissue fillers included tissue necrosis, inflammatory nodules, hypersensitivity reaction, and blindness and cerebral ischemia.
CONCLUSION: The injector should be comfortable in diagnosing and managing the above complications, and the patient should be counseled about these potentially harmful adverse events prior to injection.
J Drugs Dermatol. 2015;14(5):486-491.
Amy Taub MD| |
Vivian W. Bucay MD FAAD| |
Mona D. Mislankar MD, Rajiv K. Nathoo MD, and Sailesh Konda MD| |
Derek Ho BSa and Jared Jagdeo MD MSa, b, c| |
OBJECTIVE: Evaluate the biological properties, including biochemical, biophysical and rheological, of this new 20 mg/ml HA dermal filler and discuss the importance of these properties in clinical applications.
METHODS AND MATERIALS: A systematic search of the computerized bibliographic databases Medline, Embase, Embal, Biosis, SciSearch, Pascal, HCAPlus, IPA, and Dissertation Abstracts with key term “Voluma.” Four articles on the biological properties of this new 20 mg/ ml HA dermal filler were suitable for inclusion in this review.
RESULTS: Biological analysis of elasticity and viscosity values of this new 20 mg/ml HA dermal filler demonstrated intermediate properties in three studies and high in one study compared to other HA dermal fillers. This 20 mg/ml HA dermal filler retained the highest elasticity and viscosity values at temperature of 37°C. Histology demonstrated that this 20 mg/ml HA dermal filler has an intermediate pattern of distribution within the superficial and deep reticular dermis.
CONCLUSION: This 20 mg/ml HA dermal filler demonstrated volumizing ability, and maintaining viscosity and free-flowing characteristics for easy injection, tissue lifting, and molding. We hope future research incorporates biological properties analysis of this HA dermal filler in clinical trials.
J Drugs Dermatol. 2015;14(1):50-54.
Kenneth Beer MD PA and Karen Rothschild JD| |
Dissolving Collagen Fillers: Enzymatic Degradation of Some Problematic Filler Circumstances May Now Include Collagens
William D. Tutrone MD and Joel L. Cohen MD| |
Review of Periorbital and Upper Face: Pertinent Anatomy, Aging, Injection Techniques, Prevention, and Management of Complications of Facial Fillers
Julie Woodward MD| |
Melissa Meland BS,a Chris Groppi MS,a and Z. Paul Lorenc MDb| |
MATERIALS AND METHODS: The rheological properties of complex viscosity (η*) and elastic modulus (G’) were measured for 2 types of CaHA fillers [CaHA without lidocaine and CaHA (+) with integral 0.3% lidocaine] and 5 HA fillers using an oscillation frequency sweep at a sheer stress of 5 pascal tau (Pa) and an interpolation of 0.7 Hz.
RESULTS: CaHA with and without integral lidocaine demonstrate similar η* and G’ measurements. CaHA with and without integral lidocaine demonstrates higher η* and G’ compared with HA fillers with integral lidocaine.
CONCLUSION: CaHA with integral lidocaine has a similar rheological profile to CaHA without lidocaine: the highest η* and G’ compared with available HA fillers with integral lidocaine.
J Drugs Dermatol. 2016;15(9):1107-1110.
J Drugs Dermatol. 2012;11(9):1089-1093.
David A. Kasper DO MBA, Joel L. Cohen MD, Aradhna Saxena MD, Greg S. Morganroth MD| |
Kenneth Beer MD and Mary P. Lupo MD FAAD| |
Lance H. Brown, MD; and Paul J. Frank, MD| |
Reversing Facial Fillers: Interactions Between Hyaluronidase and Commercially Available Hyaluronic-Acid Based Fillers
Veena Rao MD,a Sulene Chi MD PhD,a and Julie Woodward MDa,b| |
METHODS: Four commonly used HA fillers were exposed to varying concentrations of Vitrase (ovine testicular hyaluronidase) and Hylenex (human recombinant hyaluronidase) in vitro. The gross properties of these fillers were then observed to evaluate time- and dose-response; photographs were obtained to allow visual comparison at 1 minute and 5 minutes post-exposure.
RESULTS: At a concentration of 0.1 mL Vitrase to 0.2 mL filler, Restylane dissipated most followed by Juvéderm; Belotero most retained its form. Hylenex at the same concentration showed similar results, again affecting Restylane most and Belotero least. Response to treatment with both hyaluronidases increased substantially over time, increasing progressively from exposure to 5 minutes post-exposure. When exposed to Hylenex at 15 U and 30 U to 0.2 mL filler, Belotero retained its form most, followed by Juvéderm, Juvéderm Voluma, and then Restylane. The effects on filler structure increased with 30 U concentration vs 15 U concentration of Hylenex.
DISCUSSION: Available hyaluronidases and HA fillers appear to have differing physical properties that influence their interaction in a time and dose-dependent manner. Knowledge of the ways in which specific fillers interact with different hyaluronidases may help achieve desired cosmesis when aiming to adjust delicate facial fillers.
J Drugs Dermatol. 2014;13(9):1053-1056.
Berthold Rzany MD ScM, Sandrine Segura MSc, Lise Anthonioz MSc, Fabien Fuchez MSc, Benjamin Herbage MSc, Philippe Kestemont MD, Hugues Cartier MD, Patrick Trevidic MD, Gerhard Sattler MD, Nabil Kerrouche MSc, Jean-Charles Dhuin MSc| |
Naissan O. Wesley MD and Jeffrey S. Dover MD FRCPC FRCP| |
Perry Robins MD, Eliot F. Battle Jr. MD, Andrew F. Alexis MD MPH, Fran Cook-Bolden MD, Yasser Alqubaisy MD, Michael P. McLeod MS, Keyvan Nouri MD, Nazanin Saedi MD, Henry H. Chan MBBS MD PhD, Jeffery S. Dover MD, Vasanop Vachiramon MD, Amy J. McMichael MD, Jason J. Emer MD, Candrice R. Heath MD, Susan C. Taylor MD, Joshua Zeichner MD| |
J Drugs Dermatol. 2012;11(1):70-72.
J Drugs Dermatol. 2012;11(9):1059-1068.
J Drugs Dermatol. 2012;11(9):1053-1058.
J Drugs Dermatol. 2011;10(11):1277-1280.
Purpura and Fillers: A Review of Pre-Procedural, Intra-Procedural, and Post-Procedural Considerations
Todd E. Schlesinger MD,a Joel L. Cohen MD,b and Sarah Ellison| |
J Drugs Dermatol. 2013;12(10):1138-1142.
Hema Sundaram MD, Susan Weinkle MD, Jason Pozner MD, Luc Dewandre MD, Joel L. Cohen MD, Lisa Donofrio MD, Daniel Cassuto MD, Timothy Flynn MD, Paul Lorenc MD, Steven Fagien MD, Gary Monheit MD, Philippe Kestemont MD, Mark G. Rubin MD, Rebecca Fitzgerald MD, Rod J. Rohrich MD, Andrew F. Alexis MD MPH, Murad Alam MD MSci, Julius W. Few MD, Gerhard Sattler MD, C. William Hanke MD MPH| |
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 2 AMA PRA Category 1 Credits.
Facial Contouring With Fillers, Neuromodulators, and Lipolysis to Achieve a Natural Look in Patients With Facial Fullness
Chytra Anand MD| |
Jean Carruthers MD, Steven R Cohen MD, John H. Joseph MD, Rhoda S. Narins MD, Mark Rubin MD| |
Hema Sundaram MD, Gary D. Monheit MD, Mitchel P. Goldman MD, Corey S. Maas MD, Nowell Solish MD, Steven H. Dayan MD, John P. Arkins BS, Ellen Marmur MD, Joel Cohen MD, Oge Onwudiwe MD, Jonathan Sykes MD, Derek H. Jones MD, Jean Carruthers MD, Hugues Cartier MD, Berthold Rzany MD ScM, Laurie Casas MD, David J. Goldberg MD JD, Patrick Trévidic MD, Rhoda S. Narins MD, Marina Landau MD, Benjamin Ascher MD, Haideh Hirmand MD| |
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 2 AMA PRA Category 1 Credits.
Gary D. Monheit MD, Chad L. Prather MD| |
Assessing Improvement of Facial Appearance and Quality of Life after Minimally-Invasive Cosmetic Dermatology Procedures Using the FACE-Q Scales
Brian P. Hibler BS, Jonathan Schwitzer MD, and Anthony M. Rossi MD| |
OBJECTIVE: We sought to determine the impact of laser resurfacing and injectable treatment (neurotoxin or fillers) on patient perceived improvement in facial appearance.
METHODS and MATERIALS: Patients were asked to complete FACE-Q scales (Satisfaction with Facial Appearance, Satisfaction with Facial Skin, and Appraisal of Facial Lines) at their pre-procedure consultation and/or at post-procedural follow-up. Item means (range 1-4) and Rasch transformed scores (range 0-100) were compared pre to post-procedure using two sample t-tests. Higher FACE-Q scores indicated greater satisfaction.
RESULTS: Overall, patients experienced a statistically significant improvement in all three scales pre- to post-procedure (P <0.05). Sub-group analysis showed statistically significant improvement in Satisfaction with Facial Appearance and Satisfaction with Facial Skin for both the laser resurfacing group and injectables group with moderate effect sizes. Improvement on Appraisal of Facial Lines trended toward improvement but did not reach statistical significance.
CONCLUSION: Our results support the ability to directly measure and quantify meaningful improvement in appearance among facial cosmetic dermatology patients using FACE-Q scales. Reporting this data is important, as this is the first step towards evidence-based cosmetic procedures in dermatology.
J Drugs Dermatol. 2016;15(1):62-67.
Julie Kenner MD PhD| |
Kathleen J. Smith MD| |
Localization and Histological Characterization of Injected Hyaluronic Acid inExcised Nasolabial Fold Tissue
Timothy M. Greco MD and Rosalie Elenitsas MD| |
Methods: Surgical correction was achieved by direct excision of the NLF, followed by advancement of the nasolabial fat compartment into the nasolabial crease. Excised tissue samples were injected with HA fillers (Restylane®, Perlane®, or layered Restylane®/ Perlane®), sectioned, and treated with histological stains.
Results: Surgical correction of NLF resulted in highly satisfactory results. HA localized primarily in the lower reticular dermis and subcutis of the excised NLF. Localization appeared similar regardless of the HA product employed.
Conclusion: Direct excision of the NLF with advancement of the nasolabial fat compartment is a successful treatment for patients with deep NLF. HA injected into the excised tissue localized near the site of injection, emphasizing the importance of proper placement of HA fillers during soft tissue augmentation.
Recent Trend in the Choice of Fillers and Injection Techniques in Asia: A Questionnaire Study Based on Expert Opinion
Soo-Keun Lee MDa and Hei Sung Kim MDb| |
OBJECTIVE: To evaluate the recent trend in the choice of fillers and injection techniques among leading dermatologists in Asia and offer guidance to those who practice facial fillers.
METHODS: A panel of dermatologists, who are recognized as filler experts and key speakers in Korea were asked to fill out an in-depth questionnaire on fillers in 2012. The results of the 2012 questionnaire are presented and compared with the questionnaire results of the exact same group of doctors in 2011.
RESULTS: Those who participated in the questionnaire study practiced fillers for an average of 10.6 years with an average of 32.8 filler cases per week. Common indications for filler injection were midface augmentation and nose augmentation. Indications that most drastically increased between 2011 and 2012 were midface and forehead augmentation. For the nasolabial folds, the most preferred choice of filler product, needle, injection technique and injection depth was Radiesse®, 27G short needle, Layering technique and the Upper subcutaneous fat layer. For filler rhinoplasty, the preferred choices were Radiesse®, 27G short needle, Linear threading technique and the Mid-deep fatty layer. For dark circles, the favored choices were Esthelis Basic®, 30G short needle, Vertical technique and the SOOF (suborbicularis oculi fat) layer. For forehead augmentation, the most favored choices were Juvederm Voluma®, 23G cannula, Linear threading technique and Fanning and the Supraperiosteal layer. The physicians’ satisfaction score for the nasolabial folds, filler rhinoplasty, dark circles and forehead augmentation was 71.5, 90, 84.5 and 87 respectively.
CONCLUSION: On general, filler experts preferred fillers with relatively high visco-elasticity for the nasolabial folds, nose augmentation and forehead augmentation but chose fillers with low visco-elasticity for dark circles. Linear treading technique (with or without fanning) was universally popular but Vertical injection was considered more useful for dark circles and the nasal tip.
J Drugs Dermatol. 2014;13(1):24-31.
The Emervel French Survey: A Prospective Real-Practice Descriptive Study of 1,822 Patients Treated for Facial Rejuvenation With a New Hyaluronic Acid Filler
David Farhi MD,a,b Patrick Trevidic MD,c Philippe Kestemont MD,d Dominique Boineau MD,e
Hugues Cartier MD,f Isaac Bodokh MD,g Patrick Brun MD,g Benjamin Ascher MD,h
and Jacques Savary MD,b,i for the Emervel French Survey Group
OBJECTIVES: To describe the current use of Emervel fillers in France.
METHODS: Prospective multicenter, cross-sectional, real-practice, descriptive survey, including 1,822 patients injected with Emervel fillers for face rejuvenation by 58 French physicians between September 2010 and July 2011. The injection modalities were left to the respective physician’s discretion.
RESULTS: The physicians were dermatologists (52.3%), surgeons (43.8%), or general practitioners (14.1%). Nasolabial folds (NLF) with a mean severity 2.4 were mainly injected with Emervel Deep (51.0%) and Emervel Classic (36.0%) (mean volume: 1.0 mL), and primarily with the linear retrograde (LR) technique (89.3%). Marionette lines (ML), with a mean severity 2.6 were mainly injected with Emervel Deep (52.5%) and Emervel Classic (34.6%) (mean volume: 0.8 mL), and mainly with the LR technique (79.5%). More than 90% of patients had scores of 0 or 1 for erythema, bruising, edema, and pain. No serious adverse events were reported up to 15 months after the injection.
CONCLUSION: These data could contribute to upcoming international consensus on optimal injection modalities of the Emervel range of HA fillers.
J Drugs Dermatol. 2013;12(5):e88-e93.
Michael H. Gold| |
Stephen E. Mercer MD PhD, Rebecca Kleinerman MD,Gary Goldenberg MD, Patrick O. Emanuel MD| |
Isabela T. Wieczorek MD,a Brian P. Hibler BS,b and Anthony M. Rossi MDc| |
J Drugs Dermatol. 2015;14(9):1043-1051.
Hema Sundaram, MD, FAAD| |
Joel L. Cohen MD and Kavita Mariwall MD| |
Gary D. Monheit, MD| |
Letter to the Editor: The New Face of Fillers: Integrating Evidence, Experience and a Little Imagination at the Next Frontier
Hema Sundaram MD| |
J Drugs Dermatol. 2011;10(5):494-498.
Rebecca S. Danhof MD MPHa and Joel L. Cohen MDa,b,c| |
J Drugs Dermatol. 2016;15(1):111-112.
Patrick Micheels MD,a Stéphanie Besse MD,b and Didier Sarrazin MDc| |
METHOD: The “resistance traction test” and “cohesiveness test” were conducted according to standard methods. Juvéderm® Volbella™ gel was injected into the buttock area, both in the superficial reticular and mid-reticular dermis. Tissue samples were analyzed at days 0, 15, and 90 by histology and immunohistochemistry, and visualized using electron microscopy. For Volbella™ gel, the same ultrasound devices as previously used were employed.
RESULTS: Prior to staining, Volbella™ gel presented resistance to spreading, suggesting a certain degree of cohesiveness. When smeared between two slides and following toluidine blue staining, the gel was visible through the microscope in the form of multiple tiny discrete particles, possibly resulting from gel desintegration. At 1/3 dilution with saline serum, Volbella™ gel disintegrated into several lumps, whereas at 1/1 dilution, Volbella gel appeared more cohesive. Yet when adding one drop 70% ethanol, the gel resembled a poorly defined magma, with numerous small lumps. On ultrasound, Volbella™ gel was found to leak in the hypodermis. On histological analysis, Volbella™ gel was visible as pools of variables sizes, particularly in the superficial and mid-reticular dermis, but also hypodermis.
CONCLUSION: Juvéderm Volbella™ gel appears to be a gel characterized by low-medium cohesiveness. The study findings, combined with our previous work, show that HA fillers using Vycross™ technology are not ideally suited for superficial use, unlike HA fillers using CPM technology™.
J Drugs Dermatol. 2016;15(9):1092-1098.
J Drugs Dermatol. 2012;11(9):1069-1079.
Patrick Micheels MD,a Didier Sarazin MD,b Stéphanie Besse MD,c and Badwi Eliasd| |
J Drugs Dermatol. 2017;16(2):154-161.
Erin Gilbert MD PhDa and Lucia Calvisi MDb| |
OBJECTIVE: To analyse and discuss the approach to midface as well as lip and perioral volume restoration by two independent dermatologists working in the US and Italy.
METHODS: Seven patients were selected for discussion and divided into two groups: 1) those requiring midface volumization and 2) those undergoing perioral or lip volume replacement. Patients in the midface group were injected with Juvéderm Voluma® XC, Juvéderm® Volift® with lidocaine, Restylane- L®, Perlane-L® or Radiesse®. Patients in the perioral and/or lip group were injected with Juvéderm® Volbella™, with lidocaine, or Belotero Balance™. Patients were photographed before and immediately after injection to evaluate aesthetic outcomes. In each case, filler selection was based upon patient characteristics, anatomical considerations and inherent filler properties.
Results: All patients were extremely satisfied with their treatments. There were no significant immediate or delayed complications following treatment with any of the dermal fillers used.
CONCLUSIONS: Volume restoration in the midface and perioral or lip region can be effectively achieved using a variety of dermal fillers. The dermal filler portfolio available in Europe is exponentially larger than that in the US. Product selection in either market is ultimately the result of the physician’s experience injecting each dermal filler, as well as his or her personal preferences.
J Drugs Dermatol. 2014;13(1):67-74.
Stefanie Luebberding PhDa and Macrene Alexiades-Armenakas MD PhDa,b| |
In October 2013 the FDA approved for the first time ever an injectable dermal filler for the augmentation of age-related volume loss. This low-molecular-weight (LMW) 20mg/ml hyaluronic acid (HA) filler competes on the market with poly-L-lactic acid (PLLA) and calcium hydroxylapatite (CaHA), that have been used off-label for many years to restore age-related volume loss. The safety profile and efficacy of all three injectables has been intensively evaluated in innumerous clinical studies. However, each volume filler has its benefits and disadvantages, including usage, method of action and duration of effect that are reviewed in this article.
J Drugs Dermatol. 2013;12(12):1339-1344.
Christine S. Ahn BA,a Rosa Mateus MD,b Irfan Khan BA,c Babar K. Rao MDb,d| |
J Drugs Dermatol. 2013;12(12):1477-1480.
A Novel, Multistep, Combination Facial Rejuvenation Procedure for Treatment of the Whole Face With IncobotulinumtoxinA, and Two Dermal Fillers- Calcium Hydroxylapatite and a Monophasic, Polydensified Hyaluronic Acid
Tatjana Pavicic MD,a Julius W. Few MD,b and Jürgen Huber-Vorländer MDc| |
J Drugs Dermatol. 2013;12(9):978-984.
Jonathan M. Sykes MD,a Amir Allak MD MBA,a and Brian Klink MDb| |
Cheryl Burgess MD| |
David Stocks BSc (Hons),a Hema Sundaram MD,b Jason Michaels MD,c Manzer J. Durrani PhD,d Mitchell S. Wortzman PhD, d Diane B. Nelson BSN MPHd| |
Background: Hyaluronic acid (HA) gels are commonly injected into the skin to lift rhytides and to improve facial appearance. The different processes used in their manufacture and formulation yield products with unique physical characteristics that play an important role in predicting their clinical performance.
Objective: The following rheologic evaluation was performed to objectively measure the physical characteristics of HA dermal filler products derived from similar bacterial sources and containing the same butanediol diglycidyl ether cross-linker, but formulated using different manufacturing techniques. The objective of this study was to evaluate the physical characteristics of two distinct families of HA products, thereby providing clinicians with a greater understanding of these products' attributes and the ability to optimize their use in the treatment of patients seeking facial rejuvenation.
Materials and Methods: The physical properties of commercially-available dermal fillers containing HA were evaluated using rheologic testing methods under clinically-relevant conditions. Additionally, light microscopy was used to assess the particulate nature of each product.
Results: The gels tested demonstrated a broad range of elasticity, firmness and viscosity. Light microscopy confirmed the particulate nature of each product and revealed HA particles of varying size and distribution.
Conclusion: This rheologic evaluation demonstrates that differences exist among the HA products tested including gel elasticity, viscosity, and the range and distribution of gel particle sizes. Understanding the distinct physical characteristics of different HA dermal fillers and how these characteristics may predict their clinical behavior can assist clinicians in achieving the desired results in patients seeking facial rejuvenation.
J Drugs Dermatol. 2011;10(9):974-980.
Derek Ho BSa and Jared Jagdeo MD MSa,b,c| |
OBJECTIVE: We sought to systematically review clinical studies and expert opinions of this 20 mg/ml HA dermal filler and to provide evidence-based recommendations and expert opinions.
METHODS AND MATERIALS: A search of the computerized bibliographic databases Medline, Embase, Embal, Biosis, SciSearch, Pascal, HCAPlus, IPA, and Dissertation Abstracts was performed on August 18th 2014.
RESULTS: Thirteen articles met inclusion and were included in our review: clinical trials with this 20 mg/ml HA dermal filler (10) and expert opinions and questionnaire survey studies of experts (3). This 20 mg/ml HA dermal filler has shown consistent, favorable results for treatment of age-related facial volume loss, aesthetic enhancement, and HIV facial lipoatrophy.
CONCLUSION: HA fillers are safe and effective with minimal recovery time and complications. Future studies with longer follow-up period and use of this 20 mg/ml HA dermal filler on areas other than midface may provide additional efficacy and safety outcomes.
J Drugs Dermatol. 2015;14(9):934-940.
Scientific Proceedings From Select Sessions at the2010 Orlando Dermatology Aesthetic & Clinical (ODAC) Conference–Part II
Leon H. Kircik MD,Sandeep Kumar MD, Leon H. Kircik MD, Mercedes E. Gonzalez MD, Dee Anna Glaser MD, Utpal Patel MD PhD, Rebecca Fitzgerald MD| |
Emmy M. Fernandez MD, Christine L. Mackley MD| |
Ana Rita Rodrigues-Barata MD and Francisco M. Camacho-Martínez MD| |
OBJECTIVE: To evaluate the type and management of undesirable effects of nonanimal reticulated or stabilized HA observed in our cosmetic unit in the past 3 years.
MATERIALS and METHODS: The consecutive patients using HA attending to our clinic in the past 3 years were divided into 3 categories, according to the time of presentation of the adverse reactions: immediate, early, and late-onset complications. All patients were treated.
RESULTS: Twenty-three patients presented to our clinic complaining of complications after soft tissue augmentation with HA. Ten patients presented immediate-onset complications, 8 showed early-onset complications, and 5 cases complaint of late-onset complications. Treatment of the first group consisted of hyaluronidase injection, massage, and topical antibiotics. Early- and late-onset complications were treated with intralesional triamcinolone acetonide. All patients improved, with the exception of a woman with recurrent granulomas.
CONCLUSION: Generally, undesirable effects of HA (immediate, early, or late onset) are not frequent, and when present, they improve if treated properly. Physicians need to be aware of these possible adverse events in order to establish proper treatment and prevent scarring or other sequelae.
J Drugs Dermatol. 2013;12(4):e59-e62.
Brighter Eyes: Combined Upper Cheek and Tear Trough Augmentation: A Systematic Approach Utilizing Two Complementary Hyaluronic Acid Fillers
J Drugs Dermatol. 2012;11(9):1094-1097.
Tatjana Pavicic MD| |
J Drugs Dermatol. 2013;12(9):996-1002.
The Optimal Filler: Immediate and Long-Term Results With Emulsified Silicone(1,000 centistokes) With Cross-Linked Hyaluronic Acid
Methods and Materials: A simple, permanent method of tissue augmentation is described. U.S. Food and Drug Administration- approved liquid silicone (Silikon®) is emulsified with cross-linked hyaluronic acid through a Luer-Lok to Luer-Lok connector between two 3-cc syringes. This stable emulsion is injected through a 27G needle or through a 25G or 27G microcannula into the middermis, subcutaneous tissue, or periosteum.
Results: The results of 95 cases are described. The emulsion is most beneficial for distensible acne valleys, nasolabial folds, glabellar frown lines, augmentation of the vermilion border of the lips, and projection of the nose, cheekbones, and chin. Exterior nasal deviations and soft tissue defects are also improved. Complications are minimal and include temporary bruising, erythema, and mild edema. Any temporary small nodules are easily leveled with massage. Occasionally, it takes a repeat session at 1 month to completely elevate depressions. The resulting elevations remain stable during the 2-year follow-up period. No silicone granulomas have developed.
Conclusions: This methodology has replaced many indications for temporary, semipermanent, or permanent fillers.
J Drugs Dermatol. 2012;11(11):1336-1341.
Kenneth Beer MD PA and Nowell Solish MD| |
Kenneth R. Beer MD FAAD,a Stephanie Bayers BSBA,b and Jacob Beerc| |
J Drugs Dermatol. 2014;13(suppl 1):s17-s20.
Kenneth R.Beer MD| |
George Cohen MD and Annyce Treherne MD| |
Susan Weinkle MD| |
D. Vleggaar MD, R. Forte MD| |
Deborah S. Sarnoff MD FAAD FACPa,b and Robert H. Gotkin MD FACSb,c| |
OBJECTIVE: To demonstrate that a combination technique called ACELIFT – an acronym for the Augmentation of Collagen and Elastin using Lasers, Injectable neurotoxins, Fillers, and Topicals – in selected patients, is a viable, safe, and effective alternative to a facelift.
METHODS: Ten healthy women, ages 50 to 62 (mean age = 58), with cervical and facial stigmata of aging were enrolled in a prospective study conducted in the authors’ private practice. Patients underwent a two-step procedure; the first step was laser lipolysis of the submental and anterior cervical areas with a pulsed 1440nm Nd:YAG laser with a side-firing fiber (PrecisionTx, Cynosure, Westford, MA). Three months later, the patients were treated in a single session that combined injectable neurotoxin, fillers, and fractional (Fx) CO2 laser resurfacing delivered in a novel “hammock” distribution. After two weeks, following complete re-epithelialization, the patients were started on a topical regimen that included daily use of sunscreen and antioxidants and nightly use of retinoids and peptides. This regimen was continued for a period of six months when all patients returned for final evaluation.
RESULTS: Nine months following the initiation of treatment, all patients were evaluated by the following: Global Aesthetic Improvement Scale, cervicomental angle scale, physician, and subject evaluation. Clinical improvement was evident, and often marked, for all subjects. Both physician and subject satisfaction scores were high, indicating overall satisfaction with the procedure and the outcomes. Side-effects were mild and transient; there were no incidents of adverse scarring, thermal injuries, permanent nerve injury, or dyschromia, hematomas, seromas, or infection. Subjects were likely to recommend the procedure to a friend.
CONCLUSIONS: In properly selected patients, the ACELIFT proved to be a safe and effective, minimally invasive alternative to a facelift. There was little downtime and high patient satisfaction.
J Drugs Dermatol. 2014;13(9):1038-1046.
A Novel, Volumizing Cosmetic Formulation Significantly Improves the Appearance of Target Glabellar Lines, Nasolabial Folds, and Crow's Feet in a Double-Blind, Vehicle-Controlled Clinical Trial
Patricia K. Farris MD,a Brenda L. Edison BA,b Ronni L. Weinkauf PhD,b Barbara A. Green RPh MSb| |
J Drugs Dermatol. 2014;13(1):41-46.
Composite Volumization of the Aging Face: Supra-Periosteal Space as the Foundation for Optimal Facial Rejuvenation
Z. Paul Lorenc MDa and Johnson C. Lee MDb| |
J Drugs Dermatol. 2016;15(9):1136-1141.
Martin Braun MD, Susan Braun DMD| |
Stacy R. Smith MD,a Xiaoming Lin MS RN,b and Ava Shamban MDc| |
J Drugs Dermatol. 2013;12(7):764-769.
Aesthetic Applications of Calcium Hydroxylapatite Volumizing Filler: An Evidence-Based Review and Discussion of Current Concepts: (Part 1 of 2)
Jason Emer MD FAADa and Hema Sundaram MD FAADb| |
METHODS: The first article of this two-part series provides an evidence-based review of study data pertaining to the mechanism of action and biocompatibility of CaHA filler, and its safety, efficacy and tolerability when used for aesthetic purposes. The review includes data from a number of prospective, controlled comparative studies, from several retrospective studies, and from a meta-analysis of reported complications from alloplastic filler procedures over a 20-year period. The study methodology and number of study subjects are sufficiently robust to provide a high Evidence Level for much of the data.
RESULTS: CaHA has good safety, efficacy and tolerability profiles that are comparable to those of hyaluronic acid (HA) fillers. It provides an initial, immediate volume replacement for up to 12 months followed by longer term correction due to biostimulation, resulting in collagenesis. Evidence Level II studies show longevity of 30 months or more after nasolabial fold implantation. Other studies demonstrate the appropriateness of CaHA filler for volume restoration to areas including the mid face, lower face and hands. CaHA is classified as an adjustable filler, whereas HA is fully reversible by hyaluronidase digestion. For this reason, and also because of CaHA's high viscosity and elasticity, evidence-based and experiential consensus suggests its avoidance in highly mobile areas (e.g. lips) or in anatomically unforgiving areas (e.g. the periocular region), where there may be increased incidence of nodules.
CONCLUSION: CaHA filler is safe, efficacious and well-tolerated when used appropriately. It is increasingly recognized that many patients require pan-facial volume restoration, and that many can benefit from combined treatments. Therefore, CaHA and HA fillers may be considered complementary rather than competitive to each other. The second article of this series offers a discussion of product characteristics, scientific principles and injection techniques to optimize treatment with CaHA filler, including special considerations for avoidance and management of complications.
J Drugs Dermatol. 2013;12(12):1345-1354.
Hyaluronic Acid Filler and Botulinum Neurotoxin Delivered Simultaneously in the Same Syringe for Effective and Convenient Combination Aesthetic Rejuvenation Therapy
Julie R. Kenner MD PhD| |
Tom van Eijk MD, Martin Braun MD| |
Laurel M. Morton MD,a Kevin C. Smith MD FRCPC,b Jeffrey S. Dover MD FRCPC,a,c,d,e Kenneth A. Arndt MDa,d,e,f| |
J Drugs Dermatol. 2013;12(11):1219-1222.
Steven H. Dayan MD FACS,a,b John P. Arkins BS,c Clyde C. Mathison MDd| |
Background: As the number of soft tissue filler injections increases, the number of adverse events associated with injection may rise. Impending necrosis represents a serious complication that, if not treated correctly and timely, may have grave consequences.
Objective: We describe a protocol utilizing hyaluronidase, nitroglycerin paste, aspirin, antacid and a topical oxygen therapy that may be used to treat impending necrosis subsequent to injection with soft tissue fillers.
Conclusion: We have successfully treated nine post-filler injection adverse events involving impending necrosis or necrosis following both hyaluronic acid and calcium hydroxylapatite injections using our protocol.
J Drugs Dermatol. 2011;10(9):1007-1012.
As one of the most powerful and versatile features of the human face, the eyebrow informs the perception of beauty and plays a critical role in sexual dimorphism, facial recognition, and non-verbal communication. Eyebrow hair also serves many important biologic functions, including sensory transmission and protection from the elements, as well as playing an important role in cosmesis and expression.
New technologies to tighten and resurface the skin, to grow the hair of the eyelashes and eyebrows, to smooth-en and lighten the skin, and to replace volume lost from this area have created opportunities for rejuvenation that were not possible until recently. These include prostaglandin analogues that not only increase the length and width of the eyelashes but also improve the length and girth of eyebrow hair. Use of topical bimatoprost daily resulted in an improvement of eyelashes in 78.1% of subjects after 16 weeks. Using it in conjunction with botulinum toxins, light sources, topical cosmeceuticals, and fillers such as hyaluronic acid has vastly improved physicians' ability to treat the periorbital region.
Quantifying Depth of Injection of Hyaluronic Acid in the Dermis: Data from Clinical, Laboratory, and Ultrasound Settings
Patrick Micheels MD,a Stéphanie Besse MD,b Didier Sarazin MD,c Anne Grand Vincent MD,d
Natalia Portnova MD,e Marva Safa Diana MDf
J Drugs Dermatol. 2016;15(4):483-490.
Methods:10 women aged 40 to 60 years were not preselected but were the first 10 women willing to undergo the study who fit the inclusion and exclusion criteria. Prior to receiving the filler, participants were asked to rate on a visual analog scale (VAS) from 1 to 6 how they felt about their appearance. Each woman received 1.0 cc of hyaluronic acid filler (Perlane, Medicis Corporation, Phoenix, AZ) into each cheek. Two weeks later they returned for photos and to complete the same VAS scale.
Results: Seven of ten women felt 0.5 to 2 points better about their appearance as measured by their VAS responses.
Conclusion:Cheek augmentation improves how a woman feels about her attractiveness.
J Drugs Dermatol. 2012;11(9):1077-1080.
Amir Moradi MD,a Azadeh Shirazi MD,b Veronica Pereza| |
Loss of volume in the temple can result in a gaunt, wasted appearance. Dermal filler augmentation of the temples can counteract volume loss and achieve a more balanced and youthful appearance. Although the temporal fossa is a critical area for volume restoration of the aging face, published information is limited. The authors retrospectively describe the treatment of 20 female patients who sought facial rejuvenation and received small gel particle hylauronic acid (SPG-HA) injections for temporal fossa augmentation. The authors discuss a rationale for their choice of dermal filler and provide a detailed, illustrated injection technique guide for restoring volume in the temporal fossa region with SPG-HA. There is a need for prospective, controlled studies investigating safety, efficacy and persistency of hyaluronic acid fillers in this area of the face.
J Drugs Dermatol. 2011;10(6):673-676.
Danny Vleggaar MD,a Rebecca Fitzgerald MD,b and Z. Paul Lorenc MD FACSc| |
J Drugs Dermatol. 2014;13(suppl 4):s40-s43.
An Open-label, Pilot Study to Assess the Effectiveness and Safety of Hyaluronic Acid Gel in the Restoration of Soft Tissue Fullness of the Lips
Nowell Solish MD FRCPa and Arthur Swift MD FRCSb| |
Objectives: Evaluate the effectiveness of small gel particle hyaluronic acid filler (Restylane® Injectable Gel [SGP-HA]; Medicis Aesthetics Inc., Scottsdale, AZ) in lip augmentation using the Medicis Lip Fullness Scale (MLFS). Assess subjective improvement in lip appearance using the Global Aesthetic Improvement Scale (GAIS).
Patients, Materials and Methods: Investigators treated 21 adults. The primary efficacy endpoint was an increase in lip fullness at least one grade on MLFS at eight weeks post-treatment. Adverse events were reported using patient diaries.
Results: Sixteen of 18 evaluable subjects (89%) had an improvement at least one grade on MLFS in both lips. MLFS and GAIS scores were consistent, suggesting clinically significant aesthetic improvement. Adverse effects were transient and mostly mild to moderate in severity.
Conclusion: Lip augmentation with SGP-HA was well tolerated and resulted in clinically meaningful increases in lip fullness.
J Drugs Dermatol. 2011;10(2):145-149.
Understanding, Avoiding, and Treating Potential Adverse Events Following the Use of Injectable Poly-L-Lactic Acid for Facial and Nonfacial Volumization
Danny Vleggaar MD,a Rebecca Fitzgerald MD,b and Z. Paul Lorenc MD FACSc| |
J Drugs Dermatol. 2014;13(suppl 4):s35-s39.
J Drugs Dermatol. 2011;10(2):125-132
Rachel E. Epstein DO and James Spencer MD MS| |
Babu Singh MD,a Terrence Keaney MD,b and Anthony M. Rossi MDc,d| |
J Drugs Dermatol. 2015;14(9):1052-1059.
Wm. Philip Werschler MD FAAD FAACS,a Julius W. Few Jr. MD,b Carolyn I. Jacob MD FAAD,c
John H. Joseph MD,d James M. Spencer MD MS,e and Amy Forman Taub MDf
J Drugs Dermatol. 2016;15(5):518-525.
Scott KM Barr MD FRCPC,a Arie Benchetrit MD FRCPC,b Mariusz Sapijaszko MD FRCP,c
and Anneke Andriessen PhDd
OBJECTIVE: A 24-week study evaluated clinical efficacy with HA.
METHODS AND MATERIALS: Included were 15 healthy subjects recruited from 4 centers, between ages of 35 to 65 years, who had a Wrinkle Severity Rating Scale (WSRS) score ≥ 3, indicating moderate volume loss. Revanesse® Ultra (Prollenium), a HA dermal filler, was used. Primary study outcome was physicians scored facial volume correction, using the Global Aesthetic Improvement Scale (GAIS), comparing baseline (day 0) versus 24 weeks (end) and blindly assessed photographs. Subject satisfaction and comfort was evaluated using self-administered questionnaires at day 0 and at week 24.
RESULTS: N = 15, 13 female and 2 males with a mean age (years) of 48.52 ( SD ± 10.46) received treatment with HA and completed the 24-week study. At screening they had a moderate (mean 2.85, SD ± 0.45) WSRS score. At week 24 a market facial volume restoration was shown and no adverse events were reported. All patients reported to be satisfied with the obtained results.
CONCLUSION: Good – excellent volume enhancement was noted almost immediately after the HA injections, improving patient reported quality of life aspects. HA treatment was shown to be safe.
J Drugs Dermatol. 2015;14(1):19-23.
Five-Year Retrospective Review of Safety, Injected Volumes, and Longevity of the Hyaluronic Acid Belotero Basic for Facial Treatments in 317 Patients
Objective: The objective of this article is to report on use of this HA in a German clinic, over a period of 5+ years, in 317 patients (668 treatments).
Methods and Materials: Authors retrospectively examined patient charts of 317 patients (312 females), aged 24 to 87 years. Chart review showed areas treated, range of volumes per area, and mean volumes. Patient satisfaction data was collected anecdotally over the five years.
Results: Volumes of the HA injected ranged from 0.2 mL to 3.0 mL, depending on the area being treated. No serious adverse events were noted in the chart review, nor was any Tyndall effect observed in the treated areas. Anecdotal information suggests high patient satisfaction with results, based on the return of these patients to the clinic for other treatments over the more than five years.
Conclusion: Belotero Basic provides aesthetically pleasing results for treatment of facial defects, without carrying a risk of serious adverse events. North American physicians now have a new HA to consider as part of their treatment protocols.
J Drugs Dermatol. 2012;11(9):1032-1035.
A Randomized, Split-Face, Histomorphologic Study Comparing a Volumetric Calcium Hydroxylapatite and a Hyaluronic Acid-Based Dermal Filler
Yana Yutskovskaya MD,a Evgenjia Kogan MD,b and Eugene Leshunov MDa| |
OBJECTIVE: To compare neocollagenesis and elastin production stimulated by Radiesse® (calcium hydroxylapatite; CaHA, Merz Pharmaceuticals GmbH) and a hyaluronic acid-based filler (HA; Juvéderm® VOLUMA®).
METHODS: Twenty-four women, aged 35–45, participated in this split-face, comparative study. Punch biopsies were taken 4 and 9 months after supraperiostal injection of each filler into the ipsilateral or contralateral postauricular area. Samples were analyzed for collagens type I and III, elastin, Ki-67, and inflammatory and angiogenic markers.
RESULTS: At month 4, collagen type III was greater with CaHA vs HA (P=0.0052). By month 9, type I staining was higher with CaHA vs HA (P=0.0135), whereas type III was lower with CaHA than HA (P=0.0019). Staining for elastin, Ki-67 and angiogenesis was greatest with CaHA at both timepoints. Inflammatory markers increased most with HA treatment.
CONCLUSIONS: CaHA resulted in more active, physiologic remodeling of the extracellular matrix than HA by stimulating a two-step process whereby collagen type I gradually replaced type III. Increased elastin stimulated by CaHA also indicates active remodeling. The results of this study suggest that, in the first 9 months after treatment, by reconstituting tissue homeostasis without inducing inflammation suggests CaHA has more desirable characteristics for a dermal filler than HA.
J Drugs Dermatol. 2014;13(9):1047-1052.
Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds
Daniel Schachter MD FRCPC,a Vince Bertucci MD FRCPC,b and Nowell Solish MD FRCPCc| |
This multicenter, split-face, double-blind study randomized subjects to receive treatment with CaHA (+) in one NLF and CaHA without lidocaine in the contralateral NLF. The pain level for each NLF was evaluated immediately following the injection using a 10-cm visual analog scale (VAS), and every 15 minutes for 60 minutes plus follow-up visits. Additional endpoints included aesthetic outcomes and subject preference. All subjects (N=102) received treatment.
CaHA (+) treatment resulted in a statistically and clinically significant reduction in pain ratings immediately after injection compared with CaHA. The mean difference in VAS scores for pain was -4.41 (P<0.0001). In 90% of subjects, the VAS scores were ≥2.0 cm lower for the CaHA (+)-treated NLF. A significant reduction in pain ratings throughout the first hour after injection was observed with CaHA (+) compared with CaHA (P<0.0001). Both treatment groups achieved significant aesthetic improvement; however, the pain differential resulted in a subject-reported preference for CaHA (+). CaHA (+) with integral lidocaine significantly reduces pain and is as effective as CaHA.
J Drugs Dermatol. 2016;15(8):1005-1010.
Joel Lee Cohen MD FAAD and Ashish C. Bhatia MD FAAD| |
Methods: In this randomized, double-blinded, placebo-controlled split-face study, 20 subjects with bilateral facial telangiectasia were treated with a pulsed dye laser (PDL) device at purpuric settings. The test articles, a gel containing vitamin K oxide and placebo (vehicle), were each randomly assigned to one side of the subject’s face. Subjects applied the test articles twice a day for the following 9 ± 1 days. Improvement in both focal and general field purpura on each side of the face was assessed by the investigator using photographs. A scale of -100% (worsening) to 100% (improving) was used to rate photos against a baseline photograph obtained 15–30 minutes after treatment with the PDL device.
Results: Resolution of the field of purpura was consistently greater with the vitamin K oxide gel after the second day of treatment. The greatest difference between the vitamin K oxide gel and placebo scores occurred on the fourth day after treatment. Although differences in active versus placebo scores did not reach statistical significance during the nine-day study period, a trend toward faster resolution of purpura with the active product was seen. Treatment-related adverse effects were not observed in any subject.
Conclusion: Vitamin K oxide gel appears to hasten the resolution of pulsed dye laser-induced purpura in subjects being treated for bilateral facial telangiectasia, and may well be useful in accelerating resolution of facial bruising from other cosmetic procedures such as fillers used for soft-tissue augmentation as well as other types of cutaneous surgical procedures.
The Evaluation of Hyaluronic Acid, With and Without Lidocaine, in the Filling of Nasolabial Folds as Measured by Ultrastructural Changes and Pain Management
Josefina Royo de la Torre MD, Paloma Cornejo MD, Gema Pérez MD, Irene Cruz MD, Estefania Muñoz BSc, Maria J. Isarría MD, and J. Moreno-Moraga MD| |
OBJECTIVE: To compare the 1-year clinical results of filling the nasolabial fold with 2 types of filler: large-gel particle HA and large-gel particle HA plus 0.3% lidocaine (HA+L). We compared the level of pain during treatment and 10 minutes after treatment and assessed the safety and efficacy profile, satisfaction, and histological findings (using reflectance confocal microscopy [RCM]).
MATERIALS and METHODS: We performed a comparative, parallel-group, double-blind trial with an external observer (blinded to the type of treatment administered). The filler was applied to the nasolabial fold in 119 patients (HA in 62 patients and HA+L in 57). Patients were followed at months 3, 9, and 12. Pain was evaluated using a visual analog scale. Efficacy and satisfaction were evaluated using the Wrinkle Severity Rating Scale and the Global Aesthetic Improvement Scale. RCM images (n=32) were taken at baseline and at months 3 and 12.
RESULTS: Pain: The severity of pain was decreased in patients treated with HA+L on application (P<.001) and 10 minutes later (P=.008). Efficacy and satisfaction: No significant differences existed between the 2 groups at months 3, 9, and 12. RCM: Skin rejuvenation occurred with a 32% increase in the height of the dermoepidermal junction at month 12 (P<.001), which was similar in both groups. Adverse events: At month 3, the most common adverse events (AEs) were erythema (68%) and hematoma (11%). No AEs were recorded at months 9 or 12.
CONCLUSION: The use of HA+L provides pain relief without affecting efficacy, satisfaction, safety, or the duration of results. RCM showed that the changes in the dermoepidermal junction represented a histological improvement in the skin with similar results in both groups.
J Drugs Dermatol. 2013;12(3):e46-e52
Mid-Face Volumization With Hyaluronic Acid: Injection Technique and Safety Aspects from a Controlled, Randomized, Double-Blind Clinical Study
Welf Prager MD,a Karla Agsten MD,b Maria Kravtsov MSc,c and Prof. Martina Kerscher MDd| |
BACKGROUND: Injection of hyaluronic acid (HA) volumizing fillers in the malar area is intended for rejuvenation of the mid-face. The choice of products, depth, and technique of injection depends on the desired level of volume enhancement and practitioners’ preferences.
OBJECTIVE: To describe a volumizing injection technique in the scope of a controlled, randomized, double-blind, single-center, split-face clinical study. Materials & Methods: A total of 45 subjects with bilateral symmetrical moderate to severe volume loss in the malar area received a single 2 mL injection of CPM®-26 (Cohesive Polydensified Matrix®) on one side and VYC®-20 (VYCROSS®) on the contralateral side of the face. The same injection technique was applied for both sides of the face. Use of anesthetics, overcorrection, and touch-ups were not permitted. The investigator completed a product satisfaction questionnaire. Adverse events (AE) and injection-site reactions (ISRs) were reported during the study.
RESULTS: The products were placed at the epiperiosteal depth in 88.9% (n=40), at the subdermal depth in 8.9% (n=4) and at both levels in 2.2% (n=1) of subjects. Fanning technique using cannulae was applied in most cases (97.8%, n=44). Results of the investigator satisfaction questionnaire allowed to characterize CPM-26 in comparison to other volumizing gels. Both study products were generally well tolerated. Local reactions were transient and of mild to moderate intensity, with the most frequent ones being redness, pain, and swelling.
CONCLUSION: Adequate injection technique in volumizing treatments is essential to create a natural aesthetic rejuvenation while respecting the safety aspect of the procedures. A 22G blunt cannula used with CPM-26 was preferred due to an easier and a more homogeneous distribution of the product. The investigator also appreciated CPM-26 for its ease of injection, positioning, lifting, and volumizing capacity.
J Drugs Dermatol. 2017;16(4):351-357.
Objective: To compare injections of filler with microcannulas versus hypodermic needles in terms of ease of use, amount of filler required to achieve desired aesthetic outcome, perceived pain by patient, adverse events such as bleeding and bruising and to demonstrate the advantages of single-port injection technique with the blunt-tip microcannula.
Materials and Methods:Ninety-five patients aged 30 to 76 years with a desire to augment facial, décolleté, and hand features were enrolled in the study. Subjects were recruited in a consecutive manner from patients interested in receiving dermal filler augmentation. Each site was cleaned with alcohol before injection. Anesthesia was obtained with a topical anesthesia peel off mask of lidocaine/tetracaine. Cross-linked hyaluronic acid (20 mg to 28 mg per mL) was injected into the mid-dermis. The microcannula or a hypodermic needle was inserted the entire length of the fold, depression or lip and the filler was injected in a linear retrograde fashion. The volume injected was variable, depending on the depth and the extent of the defect. The injecting physician assessed the ease of injection. Subjects used the Visual Analog Scale (0-10) for pain assessment. Clinical efficacy was assessed by the patients and the investigators immediately after injection, and at one and six months after injection using the Global Aesthetic Improvement Scale (GAIS) and digital photography.
Results: Overall, the Global Aesthetic Improvements Scale (GAIS) results were excellent (55%), moderate (35%), and somewhat improved (10%) one month after the procedure, decreasing to 23%, 44%, and 33%, respectively, at the six month evaluation. There was no significant differences in the GAIS score between the microcannula and the hypodermic needle. However, the Visual Analog Scale for pain assessment during the injections was quite different. The pain was described as 3 (mild) for injections with the microcannula, increasing to 6 (moderate) for injections with the hypodermic needle. Bruising and ecchymosis was more marked following use of the hypodermic needle.
Conclusion:Using the blunt-tip microcannula as an alternative to the hypodermic needles has simplified filler injections and produced less bruising, echymosis, and pain with faster recovery.
J Drugs Dermatol. 2012;11(9):1098-1103.
Deborah S. Sarnoff MD| |
The Need for Consensus Recommendations on the Use of Injectable Poly-L-LacticAcid for Facial and Nonfacial Volumization
Danny Vleggaar MD, Rebecca Fitzgerald MD, and Z. Paul Lorenc MD FACS| |
Perry Robins MD| |
Elizabeth K. Hale MD| |
Hema Sundaram MD FAAD| |
Kenneth R. Beer MD FAAD| |
Successful Treatment of Calcium Hydroxylapatite Nodules With Intralesional 5-Fluorouracil, Dexamethasone, and Triamcinolone
Shino Bay Aguilera DO,a Miguel Aristizabal MD,b and Ann Reed DOc| |
J Drugs Dermatol. 2016;15(9):1142-1143.
Effect of Different Crosslinking Technologies on Hyaluronic Acid Behavior: A Visual and Microscopic Study of Seven Hyaluronic Acid Gels
Patrick Micheels MD,a Didier Sarazin MD,b Christian Tran MD,c and Denis Salomon MDd| |
OBJECTIVE: To examine the different properties of a range of HA gels using simple and easily reproducible laboratory tests to better understand their suitability for particular indications.
METHODS AND MATERIALS: Hyaluronic acid gels produced by one of 7 different crosslinking technologies were subjected to tests for cohesivity, resistance to stretch, and microscopic examination. These 7 gels were: non-animal stabilized HA (NASHA® [Restylane®]), 3D Matrix (Surgiderm® 24 XP), cohesive polydensified matrix (CPM® [Belotero® Balance]), interpenetrating network-like (IPN-like [Stylage® M]), Vycross® (Juvéderm Volbella®), optimal balance technology (OBT® [Emervel Classic]), and resilient HA (RHA® [Teosyal Global Action]).
RESULTS: Cohesivity varied for the 7 gels, with NASHA being the least cohesive and CPM the most cohesive. The remaining gels could be described as partially cohesive. The resistance to stretch test confirmed the cohesivity findings, with CPM having the greatest resistance. Light microscopy of the 7 gels revealed HA particles of varying size and distribution. CPM was the only gel to have no particles visible at a microscopic level.
CONCLUSION: Hyaluronic acid gels are produced with a range of different crosslinking technologies. Simple laboratory tests show how these can influence a gel’s behavior, and can help physicians select the optimal product for a specific treatment indication.
Versions of this paper have been previously published in French and in Dutch in the Belgian journal Dermatologie Actualité. Micheels P, Sarazin D, Tran C, Salomon D. Un gel d’acide hyaluronique est-il semblable à son concurrent? Derm-Actu. 2015;14:38-43.
J Drugs Dermatol. 2016;15(5):600-606.
Andrew F. Alexis| |
Neil Crowson MD,a and Travis W. Blalock MDb| |
Lindsay K. McGuire MD,a Elizabeth K. Hale MD,a and Loyd S. Godwin MDb| |
J Drugs Dermatol. 2013;12(10):1181-1183.
Ralph Fiore II DO, Sarah M. Coffman DO MSc, and Richard Miller DO| |
J Drugs Dermatol. 2013;12(3):353-357.
William Levis MD| |
Resident Rounds: Part I - Program Spotlight: New York Medical College Dermatology Residency Program, New York, NY
Nikoo Cheraghi MD and Bijan Safai MD| |
Jesper F. Nygart MD,a Victoria A. Nygart MSoc,a Marie Borggren PhD,b Michael Tvede MDc| |
METHOD: This retrospective study of outcomes following polyacrylamide hydrogel injections includes 657 subjects from one centre, which had facial injections from 2001 and 2011. Until 2007 prophylactic antibiotics were not given prior to treatment, but in September 2007 a single oral dose of azithromycin (Zitromax) and moxifloxacin (Avelox) was introduced as prophylactic antibiotics. A total of 496 subjects were injected before 2007 without antibiotic prophylactic treatment, and 161 subjects received these two antibiotics prior to treatment from September 2007.
RESULTS: The prophylactic antibiotics (azithromycin and moxifloxacin) significantly reduced the incidence of clinical signs of inflammation/infections from 7 to 2% (P=0.03).
CONCLUSION: Even though the incidence of inflammation/infections following injection of polyacrylamide hydrogel is relatively low, it may be reduced further by using prophylactic antibiotic treatment. Based on our experience, we recommend prophylactic antibiotics to patients who have facial augmentation with polyacrylamide hydrogel in order to avoid infection and risk of biofilm formation due to contamination during injection with naturally occurring micro flora from skin and lips.
J Drugs Dermatol. 2014;13(5):571-573.
Annie Chiu MD,a Sabrina Fabi MD,b Steven Dayan MD,c and Alessandra Nogueira MDd| |
J Drugs Dermatol. 2016;15(9):1076-1082.
Effect of Midfacial Volume Augmentation With Non Animal Stabilized Hyaluronic Acid on the Nasolabial Fold and Global Aethestic Appearance
Brian S. Biesman MD FACSa and Whitney P. Bowe MDb| |
METHODS: Twenty subjects with moderate midfacial volume loss and prominence of nasolabial folds underwent injection of the midface with Perlane between May and July, 2009. The average volume administered was 3.68 +/- 0.55 ml. Assessments were performed by the injecting physician and subject self-assessment for 6 months following treatment.
RESULTS: 17 of 20 subjects completed all study visits. At the 6-month follow up visit 16 of 17 subjects were found to have clinically significant improvement of the midface and 14 of 17 subjects were found to have clinically significant improvement of the nasolabial folds. No serious adverse events occurred.
CONCLUSION: In this early stage, proof-of-concept trial, the majority of patients treated demonstrated clinically significant, aesthetically pleasing improvement 6 months after injection of Perlane in the midface.
J Drugs Dermatol. 2015;14(9):943-947.
Safety and Effectiveness of Small and Large Gel-Particle Hyaluronic Acid in the Correction of Perioral Wrinkles
Background: FDA-approved for the correction of moderate-to-severe facial wrinkles and folds, small gel-particle hyaluronic acid (SGP-HA, Restylane,® Medicis Aesthetics, Inc., Scottsdale, AZ) and large gel-particle hyaluronic acid (LGP-HA, Perlane,® Medicis Aesthetics, Inc., Scottsdale, AZ) were studied to evaluate their safety for the correction of oral commissures, marionette lines, upper perioral rhytides and nasolabial folds (NLFs).
Objectives: The primary objective of this study was to investigate the safety of SGP-HA and LGP-HA in treating facial wrinkles and folds around the mouth; the secondary objective was to evaluate the effectiveness of these products.
Methods: This open-label, 4-week study at two US centers evaluated SGP-HA and LGP-HA in patients who intended to undergo intradermal injection for correction of of perioral wrinkles and folds. At screening, a 5-grade Wrinkle Severity Rating Scale (WSRS) was used to evaluate the baseline appearance of bilateral NLFs, and a 6-grade Wrinkle Severity (WS) scale was used to evaluate the appearance of bilateral oral commissures, marionette lines and upper perioral rhytides. To qualify, each patient must have had moderate-to-severe wrinkles at one pair of marionette lines and upper perioral rhytides. Each wrinkle was treated to optimal correction with either SGP-HA or LGP-HA at the discretion of the treating investigator. All reported local and systemic adverse events (AEs) were recorded. At two weeks after treatment or touch-up, the treating investigator and the patient assessed appearance using the Global Aesthetic Improvement Scale (GAIS).
Results: Twenty patients with a mean age of 59.6 years (range 49 to 65 years) were treated with an average of 5.58±1.15 mL of HA for the entire perioral area. Treatment areas included NLFs, marionette lines, oral commissures and perioral rhytides. Eighteen of 20 patients received both SGP-HA and LGP-HA. Product was injected into the mid or deep dermis using primarily linear threading and multiple punctate pools. Patients experienced a total of 66 treatment-emergent AEs (TEAEs); each patient experienced at least one TEAE. The reported events in decreasing order of occurrence were bruising, tenderness, swelling, redness, headache and discomfort. Bruising was more common in the NLFs and marionette lines than in the oral commissures and perioral rhytides. Tenderness occurred more often in the perioral rhytides than in the other areas. The maximum intensity of all TEAEs was considered mild. Most TEAEs resolved within seven days, with an average duration of four days. No serious TEAEs occurred during the study. One hundred percent of GAIS evaluations by both investigators and patients indicated improvement, regardless of filler used or area treated.
Conclusion: Both SGP-HA and LGP-HA were found to be safe and effective for the correction of perioral wrinkles and folds, with few differences among treatment areas Both investigator and patient GAIS evaluations indicated aesthetic improvement after SGP-HA and LGP-HA treatment in the perioral area.
J Drugs Dermatol. 2011;10(9):982-987.
A 12-Month, Prospective, Evaluator-Blinded Study of Small Gel Particle Hyaluronic Acid Filler in the Correction of Temporal Fossa Volume Loss
Amir Moradi MD,a Azadeh Shirazi MD,b and Jeanette Moradi CRCa| |
STUDY DESIGN: This is a US Food and Drug Administration-approved, blinded, prospective, single-center, open-label trial enrolling 20 subjects undergoing subcutaneous injection of SGP-HA for rejuvenation of the temples. Primary outcomes were measured using a standardized grading system—the Hollowness Severity Rating Scale (HSRS)—at each visit by the treating investigator, a blinded physician assessment of randomized photos using the HSRS, and patient questionnaires over a 12-month period. AEs were monitored by the investigator and via patient diaries.
RESULTS: At weeks 4, 12, and 24, and month 12, all graders (ie, investigator, blinded physician assessor, and patients) reported improvement overall in hollowness. At baseline, temporal fossa hollowness was measured as moderate to severe. At week 4 to month 12, temporal fossa was graded at none or only mild hollowness. No touch-ups were necessary at week 4 on all subjects. All AEs were mild or moderate and resolved within 2 weeks.
CONCLUSION: Our study demonstrates clinically significant efficacy and safety in the use of Restylane for temple augmentation and, thus, facial rejuventation.
J Drugs Dermatol. 2013;12(4):470-475.
Safety and Effectiveness of Hyaluronic Acid Injectable Gel in Correcting Moderate Nasolabial Folds in Chinese Subjects
Yan Wu MD PhD,a Jinhua Xu PhD,b Yi Jia MD MSc PhD,c and Diane K. Murphy MBAd| |
OBJECTIVE: To evaluate the safety and effectiveness of Juvéderm Ultra vs Restylane® for the correction of moderate NLFs in Chinese subjects.
METHODS: In this double-blind randomized study, adult Chinese subjects with moderate NLFs received Juvéderm Ultra (24 mg/mL) in 1 NLF and Restylane injectable gel (20 mg/mL) in the other NLF. NLFs were evaluated using the validated 5-point photonumeric Allergan NLF Severity Scale (NLFSS); scores ranged from 0 (“no wrinkle”) to 4 (“very deep wrinkle”). Response was defined as ≥1-point improvement at 6 months. Investigator-assessed responder rate (primary outcome), NLF mean improvement, and subject-assessed responder rate and preference were assessed.
RESULTS: Among the 104 subjects who completed the study, median initial volumes (mL) were 0.8 (range, 0.2–1.4) for Juvéderm Ultra and 0.8 (0.3–1.5) for Restylane; median touch-up volumes were 0.3 (0.1–0.5) and 0.3 (0.1–0.5), respectively. At 6 months, investigator-assessed responder rates were 87.3% for both products, indicating that Juvéderm Ultra was noninferior to Restylane; mean improvement in NLFSS scores from baseline was 1.0 for both products. At 6 months, Juvéderm Ultra and Restylane subject-assessed responder rates were 86.3% and 79.4%, respectively, and mean improvement in NLFSS scores from baseline was 1.2 and 1.0, respectively. Among subjects who expressed a preference, 57.9% preferred Juvéderm Ultra. For both products, the most commonly reported treatment site responses were swelling, firmness, and tenderness; treatment site responses were generally mild or moderate in severity. Juvéderm Ultra had fewer severe responses than Restylane.
CONCLUSIONS: Juvéderm Ultra is noninferior to Restylane and is a safe and effective treatment for correcting moderate NLFs in Chinese subjects.
J Drugs Dermatol. 2016;15(1):70-76.
Amy E. Rose MD| |
Optimizing Facial Rejuvenation Outcomes by Combining Poly-L-Lactic Acid, Hyaluronic Acid, Calcium Hydroxylapatite, and Neurotoxins: Two Case Studies
Z. Paul Lorenc MD FACSa and Elizabeth Daro-Kaftan PhDb| |
J Drugs Dermatol. 2014;13(2):191-195.
Resident Rounds: Part I - Program Spotlight: Western University of Health Sciences – Silver Falls Dermatology, Salem, Oregon
Bryce L. Desmond DO and Ben M. Perry DO| |
Maritza I.Perez MD| |
Sandeep S. Saluja MD and Scott R. Florell MD| |
Resident Rounds Part I: Program Spotlight: Baylor University Medical Center Dermatology Residency Program
Mahir Patel MD and Mary E. Horner MD| |
Deborah S. Sarnoff MD| |
Safety and Efficacy of a Cohesive Polydensified Matrix Hyaluronic Acid for the Correction of Infraorbital Hollow: An Observational Study With Results at 40 Weeks
Oscar Hevia MD,a,b Bernard H. Cohen MD,b,c and David J. Howell PhDd| |
OBJECTIVE: The objective of this study was to determine the safety and efficacy of the latest hyaluronic acid filler, created with a cohesive polydensified matrix, with a low elasticity and viscosity, for infraorbital hollows correction.
METHODS AND MATERIALS: Subjects (49) with at least a grade 2 Merz infraorbital hollow scale in the Validated Assessment Scales for the mid face (0-4) of the right and/or left side were photographed and treated at baseline, and with a touch up treatment after 2 weeks if necessary. Subjects were also photographed at 2, 6, and 10 months after baseline, with optional retreatment at 6 months. The photographs were graded by a blinded sub-investigator.
RESULTS: Mean hollowness scores for both eyes, either individually or combined, at 2, 6, and 10 months were considerably improved compared to baseline (P <.001). No serious adverse events were reported. Of the 46 subjects completing the study, 31 (66%) did not request retreatment after 6 months. At 10 months, 27/31 (87%) still exhibited a hollowness improvement of at least 1-point from baseline.
CONCLUSION: Belotero Balance was safe and effective for the correction of infraorbital hollows.
J Drugs Dermatol. 2014;13(9):1030-1036.
Efficacy and Tolerability of a New Monophasic, Double-Crosslinked Hyaluronic Acid Filler for Correction of Deep Lines and Wrinkles
Tatjana Pavicic PhD
Clinic and Polyclinic for Dermatology and Allergology, Ludwig-Maximilians-University, Munich, Germany
Objective: To investigate the efficacy and tolerability of Belotero.
Methods and Materials: A total of 149 patients received injections. Efficacy was assessed on the Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS). Adverse events were recorded at each evaluation session.
Results: Mean WSRS improved significantly (P<0.001) by 1.9 score points without any decline throughout the 12-week period. Improvement was found in 89.9 percent of patients on the (GAIS), 59.7 percent of whom were designated as very much/much improved. Investigator and patient satisfaction was stated in more than 90 percent of cases as excellent/good. Adverse events, exclusively localized to the injection area, occurred in 85.9 percent of patients immediately after injection and declined to 12.8 percent in week 2. None were serious.
Conclusion: The findings indicate the benefit of the highly cross-linked, monophasic hyaluronic acid dermal filler, especially in the treatment of patients with deep and extremely deep folds. Overall, the filler appears to be well tolerated. This evaluation raised no major safety concerns.
J Drugs Dermatol. 2011;10(2):134-139.
Calcium Hydroxylapatite for Augmentation of Face and Hands: A Retrospective Analysis in Italian Subjects
Gabriele F. Muti MD,a Giorgio Astolfi MD,b Massimo Renzi MD,c and Pier P. Rovatti MDd| |
J Drugs Dermatol. 2015;14(9):948-954.
Shino Bay Aguilera DO,a Yvette A. Tivoli DO,b and Stacey J. Seastrom DOc| |
M. Shane Hamman MD,a Sabrina G. Fabi MD,b and Mitchel P. Goldman MDb
aDepartment of Dermatology, University of California San Diego, San Diego, CAbGoldman Butterwick Fitzpatrick Groff & Fabi, Cosmetic Laser Dermatology, San Diego, CA
Objective: To report and compare the efficacy and safety of HA used to treat tear trough deformities with two different injection techniques.
Materials and Methods: This is a retrospective, single-center study of 81 patients comparing the two injection techniques used for the treatment of tear trough deformities from 2003 to 2011. Hyaluronic acid was administered either in a single depot in the nasojugal groove and massaged into position or in multiple small aliquots along the inferior orbital rim and massaged into position. Patient satisfaction and the incidence of adverse reactions were evaluated.
Results: Of the 194 patients treated during the study period, 81 (42%) were successfully contacted. The overall patient satisfaction with the correction was similar for both techniques. Two patients treated with a single depot of HA were later given hyaluronidase, but otherwise, there was no statistically significant difference in the incidence and severity of side effects.
Conclusions: We describe and compare an alternative technique for the correction of tear trough deformity using a single deposition of HA in the nasojugal groove with favorable outcomes.
J Drugs Dermatol. 2012;11(12):e80-e84.
Redaelli Alessio MD,a Berthold Rzany MD ScM,b Linda Eve MD,c Yann Grangier MD,d
Pedro Herranz MD,e Frédérique Olivier-Masveyraud MD,f and Danny Vleggaar MDg
J Drugs Dermatol. 2014;13(9):1057-1066.
Hervé Raspaldo MD,a Jonquille Chantrey MD,b Lakhdar Belhaouari MD,c David Eccleston MD,d Roy Saleh MD,e Raj Acquilla MD,f and Diane K. Murphy MBAg| |
OBJECTIVE: Evaluate the safety and effectiveness of Juvéderm Volbella with Lidocaine versus non-animal stabilized hyaluronic acid with lidocaine (Restylane-L®).
METHODS: This study randomized 280 subjects desiring lip enhancement to Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated outcomes using Allergan’s Lip Fullness Scale (LFS), Perioral Lines Severity Scale, and Oral Commissures Severity Scale. Independent central reviewers (ICRs) assessed 3-dimensional photographs using these scales. Noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L was based on ICR assessment of LFS responders (≥1-point improvement from baseline) at month 3. Subjects were evaluated up to 12 months and after repeat treatment.
RESULTS: Juvéderm Volbella with Lidocaine was noninferior to Restylane-L at 3 months. Investigator assessments showed significant improvements in lip fullness (P≤.03), perioral lines (P≤.04), and oral commissures (P≤.03) with Juvéderm Volbella with Lidocaine versus Restylane-L at months 6 to 12. There was less acute swelling and fewer severe injection site responses with Juvéderm Volbella with Lidocaine. Safety and effectiveness of repeat treatment with Juvéderm Volbella with Lidocaine was comparable to initial treatment, regardless of initial filler.
CONCLUSIONS: Juvéderm Volbella with Lidocaine is safe and effective for lip and perioral enhancement, with effectiveness lasting up to 12 months.
J Drugs Dermatol. 2015;14(12):1444-1452.
Same-Patient Prospective Comparison of Botox Versus Dysport for the Treatment of Primary Axillary Hyperhidrosis and Review of Literature
Irene J. Vergilis-Kalner MD| |
J Drugs Dermatol. 2012;11(9):1081-1088.
Z. Paul Lorenc MD FACS,a Thomas Greene MD,b and Ronald W. Gottschalk MD FAAD FRCPCc| |
J Drugs Dermatol. 2016;15(6):759-762.
Ramin Fathi MD1 and Joel L. Cohen MD FAAD1,2,3| |
J Drugs Dermatol. 2016;15(7):809-815.
Kristen Lo Sicco MD, Mona Sadeghpour MD, Laura Ferris MD PhD, Lisa Grandinetti MD| |
An Evaluation of the Benefits of a Topical Treatment in the Improvement of Photodamaged Hands With Age Spots, Freckles, and/or Discolorations
Michael H. Gold MDa,b and Conor Gallagher PhDc| |
OBJECTIVE: To evaluate the efficacy of a topically applied cream formulated with an alpha-hydroxy acid, depigmenting agents, and antioxidants to improve the appearance of characteristics associated with photodamaged hands.
METHODS: This was a single-site, open-label study of a proprietary topical treatment (Vivité Vibrance Décolleté, Allergan, Inc.) in adult female subjects with moderate-to-severe photoaging of the hands. The treatment was administered to the hands twice daily over an 8-week period. Treatment efficacy was assessed at baseline and weeks 4 and 8 using the Investigator Global Assessment (IGA) score based on the percentage coverage and color depth of photodamaged areas. The severity of age spots, freckles, and hand skin discoloration were also assessed; digital and ultraviolet photography of the hands was performed. Subject-reported assessments of treatment efficacy were evaluated using a questionnaire administered at week 8. Statistical significance was defined with an α set at P≤.05.
RESULTS: Thirty-five subjects were enrolled with a mean age of 55.6 years; 33 subjects completed the study. The IGA of the appearance of hand photodamage improved from a mean (standard deviation) score of 5.0 (0.8) at baseline to 3.1 (1.5) and 2.6 (1.3) at weeks 4 and 8, respectively (1=mild; 9=severe). Based on expert-grader evaluation, subjects demonstrated statistically significant improvements from baseline in IGA at weeks 4 and 8 in age spots and freckling at weeks 4 and 8, (P<.0003) and in skin discolorations at week 8 (P<.05). The majority of subjects reported that they perceived improvements in each of the 9 parameters associated with skin appearance. No adverse events were reported.
CONCLUSIONS: The appearance of age-related hand pigmentation characteristics were significantly improved at 4 and 8 weeks of treatment. Subjects reported post-treatment improvements in other characteristics associated with healthy skin.
J Drugs Dermatol. 2013;12(12):1468-1472.
Daneeque Woolfolk MD, Kehinde Ogunmakin MD, Jeffrey Brackeen MD, and Bryan Carroll MD| |
Background: Facial lipoatrophy is one of the most distressing manifestation for HIV patients. It can be stigmatizing, severely affecting
quality of life and self-esteem, and it may result in reduced antiretroviral adherence. Several filling techniques have been proposed
in facial wasting restoration, with different outcomes. The aim of this study is to present a triangular area that is useful to fill in facial
Methods: Twenty-eight HIV patients rehabilitated for facial wasting were enrolled in this study. Sixteen were rehabilitated with a non- resorbable filler and twelve with structural fat graft harvested from lipohypertrophied areas. A photographic pre-operative and post- operative evaluation was performed by the patients and by two plastic surgeons who were “blinded.” The filled area, in both patients rehabilitated with structural fat grafts or non-resorbable filler, was a triangular area of depression identified between the nasolabial fold, the malar arch, and the line that connects these two anatomical landmarks.
Results: The cosmetic result was evaluated after three months after the last filling procedure in the non-resorbable filler group and after three months post-surgery in the structural fat graft group. The mean patient satisfaction score was 8.7 as assessed with a visual analogue scale. The mean score for blinded evaluators was 7.6.
Conclusion: In this study the authors describe a triangular area of the face, between the nasolabial fold, the malar arch, and the line that connects these two anatomical landmarks, where a good aesthetic facial restoration in HIV patients with facial wasting may be achieved regardless of which filling technique is used.
J Drugs Dermatol 2012;11(2):202-208.
Efficacy and Safety of IncobotulinumtoxinA for the Treatment of Platysmal Bands of the Aging Neck: An Open-Label, Prospective Pilot Study
Elena I. Gubanova MD,a Olga S. Panova MD,b Elena A. Sanchez MD,b
Maria Y. Rodina MD,a and Polina A. Starovatovaa
OBJECTIVE: To determine the efficacy and safety of incobotulinumtoxinA for the treatment of platysmal bands.
METHODS: Women, 35–65 years of age, with platysmal bands scoring 2 or 3 on the validated 5-point Merz dynamic platysmal bands scale received a total of 60 U incobotulinumtoxinA divided between four platysmal bands (20 U in both medial bands and 10 U in both lateral bands). Investigator assessments according to the 5-point scale were made at baseline and from standardized clinical photographs taken at follow-up visits 14±2, 56±7 and 84±7 days after treatment. The global aesthetic improvement scale (GAIS) and a novel questionnaire were used to assess subject treatment satisfaction. Adverse events were recorded.
RESULTS: Twenty-five women (mean age 51.8 years) were included in the study. With a responder defined as a subject with at least a 1-point improvement from baseline on the dynamic platysmal bands scale, the response rate at maximum contraction was 100% at Day 14 as assessed by the investigator. By the same definition, a high response rate (96%) was maintained at maximum contraction at Day 84. Subjects reported that, at Day 84, 86.3% of the maximal effect (defined as the effect on Day 14) persisted. Subject-reported satisfaction was high, as indicated by the self-assessment on the GAIS and results from the subject satisfaction questionnaire. Treatment- related adverse events were mild and reversible.
CONCLUSION: IncobotulinumtoxinA is an effective, well-tolerated treatment for platysmal bands, with a high percentage of the treatment effect maintained at 3 months after treatment. Investigator and subject assessments both indicated high levels of treatment satisfaction.
J Drugs Dermatol. 2013;12(12):1461-1466.
Background: Upper lip wrinkling is a common complaint of patients seeking perioral rejuvenation. Lately, manual dermabrasion has
become more popular due to its safety, minimal cost, and favorable results. In several hospitals, the ability to efficiently ste rilize
sand paper has been questioned.
Methods: Between 2007 and 2010, 29 patients underwent manual dermabrasion of the skin of the upper lip using an electric cautery scratch pad during their surgeries.
Results: The average patient was aged 60.2 years. The average healing period was 5.8 days. Patient satisfaction from the procedure ranged from very good to excellent. No serious or long lasting complications have been encountered during our follow-up period.
J Drugs Dermatol.2012;11(5):649-652.
Pilot Comparative Study of the Topical Action of a Novel, Crosslinked Resilient Hyaluronic Acid on Skin Hydration and Barrier Function in a Dynamic, Three-Dimensional Human Explant Model
Hema Sundaram MD,a Nicolas Mackiewicz PhD,b Emeline Burton MSc,b Laurent Peno-Mazzarino BSc,c Elian Lati PhD,c and Stéphane Meunier PhDb| |
METHODS: Standardized doses of each HA product were applied daily for 9 days to human skin explant surfaces. Untreated explants served as controls. Water content of the stratum corneum and entire epidermis was analyzed by Raman spectroscopy. Transepidermal water loss (TEWL) was measured to assess skin barrier function. Explant morphology and microrelief were evaluated by optical and scanning electron microscopy.
RESULTS: Crosslinked RHA achieved a significant increase in epidermal water content (7.6%) over the control. Spectral cartography confirmed a higher epidermal water content with RHA than with HMW HA or LMW HA. TEWL was reduced by 27.8% with RHA, and by 15.6% with HMW HA, but increased by 55.5% with LMW HA. Cutaneous microrelief improved with RHA. Corneocyte cohesion improved with RHA and HMW HA.
CONCLUSIONS: This comparative, multimodal study demonstrated greater benefits of topical crosslinked RHA over linear HMW HA or LMW HA in reducing TEWL, retaining and redistributing water within the epidermis, maintaining skin integrity, and improving skin barrier structure and function. RHA was a more efficacious humectant than LMW HA, and a more efficacious occlusive moisturizer than HMW HA. These integrative epidermal repair activities are of significant value for addressing primary deficits of aging skin, improving tolerance to retinoids and other topical agents, and optimizing procedural outcomes. A combination of topical and injectable HA provides an elegant model of synergistic, multi-level skin restoration.
J Drugs Dermatol. 2016;15(4):434-441.
Resident Rounds Part I. The State University of New York Downstate Medical Center Dermatology Residency Training Program
Jaimie B. Glick MD and Ravneet Ruby Kaur MD| |
Full-Face Injections of Variable Total Doses of Abobotulinum Toxin Type A: A Randomized, Phase IV Clinical Trial of Safety and Efficacy
Doris Hexsel MD,a,b Cristiano Brum MD Ms,a,c Manoela D. Porto MD,a Mariana Soirefmann MD Ms,a,b Carolina Siega BSc,a Juliana Schilling-Souza BPharm,a and Ticiana C. Rodrigues MD PhDa,d| |
OBJECTIVE: To evaluate the safety and efficacy of full-face treatments with various total doses of abobotulinum toxin A (ABO).
METHODS: A total of 90 participants were enrolled. Subjects had at least two indications for BoNT-A treatments on each third of the face (upper, middle and lower). They were randomized into 3 groups, with pre-defined total dose range of ABO, varying from 120 to 250 U.
RESULTS: Most of the subjects were women (96.5%). The statistically significant improvement from baseline lasted for more than 24 weeks for glabellar lines, and more than 16 weeks for forehead wrinkles and crow's feet, all P<0.001, with no differences between groups. The most frequent adverse event (excessive perioral weakness) was related to high dose in the perioral area.
CONCLUSIONS: This is the first study to compare safety and efficacy of different doses of ABO administered to the entire face simultaneously. As long as the recommended doses are used, concomitant injections of ABO are safe and efficient, with no increase in adverse events.
J Drugs Dermatol. 2013;12(12):1356-1362.
Jesse D. Jensen DO and Wendy McFalda DO| |
Lucija Kroepfl MBChBa and Jason J. Emer MDb| |
Shino Bay Aguilera DO FAAD,a Sean Branch DO FAAD,b and Luis Soro DO FAADa| |
Joshua A. Farhadian,a Bradley S. Bloom,b and Jeremy A. Brauera,b,c| |
J Drugs Dermatol. 2015;14(9):1029-1034.
J Drugs Dermatol. 2012;11(9):1046-1052.
Shlomit Halachmi, MD PhD,a Dan Ben Amitai MD,b,d and Moshe Lapidoth MD MPHc,d| |
MATERIALS and METHODS: Twelve consecutive patients with moderate to severe acne scarring, who had completed a series of fractional laser resurfacing, underwent microinjections of 20 mg/mL hyaluronic acid (HA) gel into discrete depressed acne scars on the face.
RESULTS: Immediate visual improvement was observed in all lesions. The procedure was well tolerated. Adverse events were limited to transient pinpoint bleeding at the injection site.
CONCLUSION: Microinjection of low viscosity HA offers a valuable technique for the treatment of discrete depressed acne scars.
J Drugs Dermatol. 2013;12(7):e121-e123.
The Evolution of Injectable Poly-L-Lactic Acid From the Correction of HIV-Related Facial Lipoatrophy to Aging-Related Facial Contour Deficiencies
Cheryl Burgess MD| |
Tapan Patel MBBS MRCP,a Oren Tevet MScb| |
This study evaluated the clinical efficacy and safety of pneumatic injections of Hyaluronic Acid in the treatment of acne scars.
Two patients (Fitzpatrick skin type IV-V) with acne scars received two sessions of pneumatic, needleless injections of crosslinked hyaluronic acid (HA) at 4-week intervals. The treatment response was assessed by comparing pre‐ and 3‐month posttreatment clinical photography.
The patients’ acne scar grade improved from 2 to 1 in the first case, and 3 to 2 in the second case, based on independent physician assessment. Patient degree of satisfaction was similar to the physicians' assessment. No significant adverse events were noted. We conclude that pneumatic injection technology to deliver HA to the tissue is an effective and safe method for improving acne scars, even in patients with dark complexion.
J Drugs Dermatol. 2015;14(1):74-76.
Quality of Life and Satisfaction of Patients After Full-Face Injections of Abobotulinum Toxin Type A: A Randomized, Phase IV Clinical Trial
Doris Hexsel MD,a,b Cristiano Brum MD Ms,a,c Manoela D. Porto MD,a Mariana Soirefmann MD Ms,a,b
Carolina Siega BSc,a Juliana Schilling-Souza BPharm,a and Ticiana C. Rodrigues MD PhDa,d
OBJECTIVE: To assess the quality of life and satisfaction of patients treated with full-face injections of variable doses of abobotulinum toxin A (ABO).
METHODS: Ninety subjects were randomized into 3 different groups, receiving 120-165 U, 166-205 U and 206-250 U, respectively. WHOQOL- BREF and Satisfaction and Self-assessment Questionnaire (SSQ) were completed by subjects up to 6 months after treatment.
RESULTS: Most of the subjects were women (96.5%). For the physical domain in WHOQOL, a difference was observed between baseline and visit 2 (p = 0.036). There was no difference between groups for mean grades regarding amount of wrinkles, beauty, harmony and symmetry. However, there was a significant difference in the mean grades between visits. Patients' opinions also showed an improvement in their self-image up to four months after treatment, according to the self-grading.
CONCLUSION: The results presented in this study show improvements in patients' quality of life during the peak of action of BoNT-A treatment, regarding the physical aspect. In addition, patients reported good satisfaction after a full-face approach.
J Drugs Dermatol. 2013;12(12):1363-1367.
Allison P. Weinkle BS,a Bryan Sofen MD,b and Jason Emer MDc| |
J Drugs Dermatol. 2015;14(11):1215-1228.
Audrey S. Wang MD,a,b Olubukola Babalola BS,a,b and Jared Jagdeo MD MSa,b,c| |
J Drugs Dermatol. 2014;13(3):288-290.
J Drugs Dermatol. 2011;10(12):1370-1375.
Joel Schlessinger MD,a Subhash Saxena PhD,b and Stuart Mohrb| |
J Drugs Dermatol. 2016;15(4):496-503.
Oge C. Onwudiwe MD,a Ellen S. Marmur MD,b and Joel L. Cohen MDc| |
J Drugs Dermatol. 2013;12(2):199-205.
Cheryl Janene Gustafson MD, Meredith Woodard PA-C, and C. William Hanke MD| |
J Drugs Dermatol. 2016;15(2):241-243.
Evaluation of a Prescription Strength 4% Hydroquinone/10% L-Ascorbic Acid Treatment System for Normal to Oily Skin
Suzanne Bruce MDa and JoAnne Watson DPMb| |
Methods: Patients with minimal or mild facial photodamage and hyperpigmentation, and normal to oily facial skin, used the treatment system for 12 weeks.
Results: Of 34 females enrolled, 30 completed. Median scores for the overall integrated assessment of photodamage, overall intensity of pigmentation, fine lines and wrinkles, tactile roughness, and laxity were significantly improved at week 12 compared with baseline. Furthermore, ≥90 percent of patients considered their skin was smoother, softer, more evenly toned, and more radiant, and 100 percent were satisfied with the overall appearance of their skin.
Conclusion: The treatment system can help to ameliorate early signs of photodamage in normal to oily skin.
J Drugs Dermatol. 2011;10(12):1455-1461.
Suzanne Bruce MD,a Jwala Karnik MD,b Laurence Dryer PhD,c and David Burkholder PhDd| |
METHODS: Female subjects age 35-65 with Fitzpatrick Skin Type I-IV and mild to moderate amounts of photodamage, fine lines, and wrinkles used Regenica® Replenishing Crème and Regenica® Renew SPF 15 for 3 months. At each visit, photos were taken of subjects while investigators completed skin grading assessments and subjects completed self-assessments. Investigator assessments included evaluation of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance, and translucence on a 5-point scale. Subjects’ self-assessments included assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness, resilience, clarity, and radiance. Changes from baseline were evaluated for each parameter and P values for changes from baseline to each study visit for investigator’s assessments and to end-of-study for self-assessments were calculated.
RESULTS: Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study. Statistically significant improvements in investigator assessments of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance and translucency compared to baseline were observed at weeks 4, 8, and 12 after initiating treatments. Progressive improvement was seen through the last study visit (visit 5, week 12). Similar statistically significant improvements in subjects’ self-assessments were seen comparing the first post-baseline visit (visit 2, week 2) to subsequent visits. 93.5 % subjects agreed (somewhat or strongly) with all of the positive subject assessment statements at week 12. Importantly, 100 % of subjects indicated at the end of the study that they would recommend the product to a friend and would want to purchase the product. No treatment-related adverse events were recorded during the study.
CONCLUSIONS: Regenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35-65 years as measured by both investigator assessments and subjects’ self-assessments.
J Drugs Dermatol. 2014;13(9):1074-1081.
A Randomized, Double-blind, Split-face Study Comparing the Efficacy and Tolerability of Three Retinol-based Products vs. Three Tretinoin-based Products in Subjects With Moderate to Severe Facial Photodamage
Michael Babcock MD,1 Rahul C. Mehta PhD,2 Elizabeth T. Makino BS CCRA MBA2| |
J Drugs Dermatol. 2015;14(1):24-30.
Nils Krueger PhD,a Stefanie Luebberding MSc,a Gerhard Sattler MD,b C. William Hanke MD,c
Macrene Alexiades-Armenakas MD,d and Neil Sadick MDe
J Drugs Dermatol. 2013;12(7):737-742.
Danielle Tartar PhD,a Tina Bhutani MD,b Monica Huynh BA,c Timothy Berger MD,b and John Koo MDb| |
J Drugs Dermatol. 2014;13(5):564-568.
Does Increasing the Dose of Abobotulinumtoxina Impact the Duration of Effectiveness for the Treatment of Moderate to Severe Glabellar Lines?
John H. Joseph MD,a Laura L. Eaton RN BSN,b James Robinson MS,c Allison Pontius MD,d and Edwin F.Williams III MDd| |
Jeremy B. Green MD,a,b Andrei I. Metelitsa MD FRCPC,c,d Joely Kaufman MD,a,b and Terrence Keaney MDe,f,g,h| |
J Drugs Dermatol. 2015;14(9):1061-1064.
A Phase I Safety and Pharmacokinetic Study of ATX-101: Injectable, Synthetic Deoxycholic Acid for Submental Contouring
Patricia Walker MD PhD,a,b Jere Fellmann PhD,b and Paul F. Lizzul MD PhD MBA MPHb| |
J Drugs Dermatol. 2015;14(3):279-284.
Deborah S. Sarnoff MD FAAD FACPa and Robert H. Gotkin MD FACSb| |
J Drugs Dermatol. 2015;14(5):472-477.
Wendy E. Roberts MD| |
J Drugs Dermatol. 2014;13(4):472-482.
Deborah S. Sarnoff MD FAAD FACP| |
Pilot, Multicenter, Open-Label Evaluation of Safety, Tolerability and Efficacy of a Novel, Topical Multipotent Growth Factor Formulation for the Periorbital Region
Hema Sundaram MD,a Michael Gold MD,b Heidi Waldorf MD,c Mary Lupo MD,d Vivien L. Nguyen PharmD,e and Jwala Karnik MDe| |
METHODS: Thirty-nine female subjects with mean age of 56.8 years who had periorbital lines and wrinkles, uneven skin texture, puffiness, and lack of skin firmness were enrolled, and 38 completed the study. All subjects applied the multipotent growth factor formulation bilaterally to the periorbital area, twice daily for 60 days. Efficacy and treatment-related adverse events were evaluated at Baseline and days 14, 30, and 60. Investigators rated the periorbital areas based on 10-point scales.
RESULTS: Subjects’ self-reported compliance with treatment was greater than 99% throughout the study. At day 60, all subjects had improvement in infraorbital brightness (≥ 2 points), moistness (≥ 2 points), wrinkles (≥ 1 point), sallowness (≥ 1 point), crepiness (≥ 1 point), smooth texture (≥ 1 point), skin tightness (≥ 1 point), and skin tone (≥ 1 point). Investigator-rated assessments showed ≥ 1-point improvement for lateral canthal wrinkles, dyschromia/mottled pigmentation, skin tone, overall brightness, and moistness. Investigator-rated scoring on the Global Aesthetic Improvement Scale (GAIS) demonstrated that 67.6% of subjects were much improved/improved at day 14, and 63.1% remained improved at day 60. Overall, 76.2% and 79.0% of subjects were very pleased/pleased/mostly pleased with the appearance of their infraorbital and lateral canthal areas at day 60. Adverse events comprised one case of mild canthal erythema, and one case of mild eye irritation, both of which were respectively resolved.
CONCLUSIONS: This pilot study demonstrated that the topical multipotent growth factor formulation was safe, effective and well tolerated for periorbital skin rejuvenation.
J Drugs Dermatol. 2015;14(12):1410-1417.
Secukinumab Self-Administration by Prefilled Syringe Maintains Reduction of Plaque Psoriasis Severity Over 52 Weeks: Results of the FEATURE Trial
Alice B. Gottlieb MD PhD,a Andrew Blauvelt MD MBA,b Jörg C. Prinz MD,c Philemon Papanastasiou PhD,d Rashidkhan Pathan MS,e Judit Nyirady MD MBA,f Todd Fox PharmD ACPR,d Charis Papavassilis MD PhDd| |
J Drugs Dermatol. 2016;15(10):1226-1234.
Improved Neocollagenesis and Skin Mechanical Properties After Injection of Diluted Calcium Hydroxylapatite in the Neck and Décolletage:A Pilot Study
Yana Alexandrovna Yutskovskaya MD PhDa and Evgeniya Alexandrovna Kogan MD PhDb| |
Quantitative & Qualitative Evaluation of the Efficacy of a 1440 nm Nd:YAG Laser With Novel Bi-Directional Optical Fiber in the Treatment of Cellulite as Measured by 3-Dimensional Surface Imaging
Bruce Katz MD| |
OBJECTIVE: To evaluate the safety and efficacy of a single cellulite treatment using an Nd:YAG 1440-nm laser delivered with a special fiber delivery system and temperature control.
METHODS: Women with cellulite on their thighs and buttocks were enrolled in a prospective Institutional Review Board–approved study. Subjects were 15 healthy females of all Fitzpatrick Skin types with cellulite (grades II-III). A single treatment was performed with an average of seven 5 x 5 cm squares treated per leg. Evaluations with 2D and 3D imaging, patient and blinded evaluator scales as well as skin histology were performed at baseline, 3 and 6 months post treatment.
RESULTS: In the 2D photographs, blinded evaluators were able to identify treated photographs versus baseline in 90% of cases and the number of sites with improvement in contour irregularities was 94%. With 3D imaging, the average decrease in skin depressions (dimples) was 49% at 6 months and 66% of patients showed improvement in overall skin contour at 6 months follow-up. Patient and physician satisfaction scores were high and no adverse events were reported.
CONCLUSION: The Nd:YAG 1440 nm laser with a special fiber delivery system produced significant improvement in cellulite with one treatment after 6 months of follow up. There were no adverse events.
J Drugs Dermatol. 2013;12(11):1224-1230.
Generational Dermatology: Model for Prevention and Multi Decade Approach Toward the Evolving, Aging Patient
Wendy E. Roberts MD FAAD| |
J Drugs Dermatol. 2013;12(12):1396-1399.
Comparing the Clinical Attributes of AbobotulinumtoxinA and OnabotulinumtoxinA Utilizing a Novel Contralateral Frontalis Model and the Frontalis Activity Measurement Standard
Mark S. Nestor MD PhDa and Glynis R. Ablon MDb| |
Background: Studies on the pharmacodynamics of abobotulinumtoxinA (ABO) and onabotulinumtoxinA (ONA) have produced inconsistent results. This may be due to the lack of objective measurement methods.
Objective: To assess and compare pharmacodynamic attributes, including onset of action, spread and efficacy of ABO and ONA using a novel Frontalis Activity Measurement Standard (FMS) and 4-point Frontalis Rating Scale (FRS).
Methods: Twenty subjects with severe frontalis lines at maximum elevation received equal volumes of ABO or ONA using a dose ratio of 2.5:1 in five injection points on contralateral sides of the frontalis (statistical n=40). Subjects were evaluated using the FMS and FRS for 30 days using pre-defined endpoints for onset and effectiveness. Other assessments included areas of effectiveness and injection pain.
Results: For ABO vs. ONA, the FMS revealed a median Initial Onset of 12 vs. 48 hours (P<0.001), Full Onset of 24 vs. 72 hours (P<0.001) and Complete Onset of three vs. five days (P=0.01). The FRS indicated an Initial Onset for ABO and ONA of 18 hours vs. two days (P=0.002), Full Onset of two vs. three days (P=0.001) and Complete Onset of four days vs. eight days (P=0.01). The FMS showed 90 percent of ABO treatment achieved Complete Efficacy vs. 75 percent for ONO, while 90 percent of ABO treatments reached Complete Efficacy using the FRS vs. 65 percent for ONO. No differences in area of effectiveness or spread were observed. Most subjects (80%) reported ABO injections were less painful than ONA injections (P<0.05).
Conclusion: The FMS appears to be a sensitive, objective tool for measuring ABO and ONA pharmacodynamics. Using a dose ratio of 2.5:1, ABO displayed significantly earlier onset of effect and less injection pain than ONA but similar areas of effectiveness.
J Drugs Dermatol. 2011;10(10):1148-1157.
Prospective, Multicenter Study to Determine the Safety and Efficacy of a Unique Radiofrequency Device for Moderate to Severe Hand Wrinkles
Janelle M. Vega MDa, Vivian W. Bucay MDb, and Flor A. Mayoral MDa| |
J Drugs Dermatol. 2013;12(1):24-26.
Novel Nonablative Radio-Frequency Rejuvenation Device Applied to the Neck and Jowls: Clinical Evaluation and 3-Dimensional Image Analysis
Lisa K. Chipps MD MS,a,b,c Jason Bentow MD,c Heidi B. Prather MD,d Jeffrey J. So MS PA-C,a
Jonathan M. Schouest BS,a and David M. Ozog MD,a,e Ronald L. Moy MDa,b
STUDY DESIGN: Forty-nine subjects received a total of two radio-frequency treatments to the face and neck one-month apart. The novel radio-frequency delivery device was used to heat the dermis between 41-43°C for five heat cycles. Primary outcome measures were clinical efficacy quantified by the Global Assessment Improvement Scale (GAIS) and a patient survey that assessed treatment satisfaction.
RESULTS: Assessments of 3D photographs revealed an overall improvement in 74% of study subjects. 85% of patients noted an overall improvement in the appearance of their skin. 81% of patients rated their post-treatment skin laxity as improved, 85% rated their skin smoothness as improved and 62% rated their skin brightness as improved.
CONCLUSION: Subjects in this study demonstrated an overall improvement in face and neck appearance with regard to skin tightening, wrinkles, and skin texture suggested by overall patient satisfaction (85%) and physician-rated GAIS improvement (74%). This study suggests that radiofrequency applied with a continuous thermal treatment device is a safe and efficacious way to improve the overall appearance of aging facial skin.
J Drugs Dermatol. 2013;12(11):1215-1218.
Objective: Review the utility of JAK inhibitors in the treatment of psoriasis.
Methods: A review was performed using PubMed and Google to identify research relevant to the treatment of psoriasis using JAK inhibitors.
Results: In a CD18 mutant PL/J mouse model with T-cell dependent psoriasiform skin disease, the JAK inhibitor R348 reduced skin inflammation, with reductions in CD4+, CD8+, and CD25+ T-cell infiltration and systemic decreases of IL-17, IL-19, IL-22, IL-23 and TNF-α. Two JAK inhibitors, CP-690,550 (tasocitinib) and INCB018424 (ruxolitinib), were effective in psoriasis clinical trials. In a phase 1, randomized, double-blind, dose escalation trial for plaque psoriasis, CP-690,050 led to improvements in Psoriatic Lesion Severity Sum score at doses greater than 5 mg. A phase 2 trial showed CP-690,050 administered at 2, 5, and 15 mg twice daily resulted in a 75% reduction in Psoriasis Area and Severity Index (PASI) in 25%, 40.8%, and 66.7% of patients, respectively, for moderate to severe psoriasis. A phase 3 study of CP-690,550 for plaque psoriasis was begun in September 2010 (NCT01163253). INCB018424, another JAK inhibitor, was used topically at 3 doses (0.5%, 1%, 1.5%) in a phase 2B, double-blind, placebo-controlled trial, resulting in improved total lesion score, global assessment, and PASI for all doses.
Conclusion: Janus Kinase inhibitors are promising potential therapeutic options for psoriasis.
J Drugs Dermatol. 2012;11(8):913-918.
Pain Management With a Topical Lidocaine and Tetracaine 7%/7% Cream With Laser Dermatologic Procedures
Joel L. Cohen MD| |
J Drugs Dermatol. 2013;12(9):986-989.
Results of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Botulinum Toxin Type A Topical Gel for the Treatment of Moderate-to-Severe Lateral Canthal Lines
Richard Glogau MD,a,b Andrew Blitzer MD DDS,c Fredric Brandt MD,d Michael Kane MD,e Gary D. Monheit MD,f Jacob M. Waugh MDG| |
Objectives: To assess the safety and efficacy of RT001 for the treatment of lateral canthal lines in a randomized, double-blind, placebo-controlled study.
Materials & Methods: Adult subjects were enrolled to receive a single treatment of RT001 (n=45) or placebo (n=45) applied topically in the lateral canthal area. The primary endpoint was the composite of the Investigator Global Assessment of Lateral Canthal Line Severity (IGA-LCL) and the Patient Severity Assessment of lateral canthal line severity (PSA) defined as a 2-point or greater improvement on both scales.
Results: At four weeks, 44.4 percent of subjects treated with RT001 achieved a 2-point or greater improvement on a rigorous composite of both the IGA-LCL and PSA scales compared to 0.0% for the placebo subjects (P<0.0001). At four weeks, 88.9 percent of subjects achieved clinically relevant improvement by investigator assessment. Adverse events were mild in severity and unrelated to study treatment.
Conclusions: RT001 appears to be a safe and well-tolerated treatment for improvement of lateral canthal lines.
J Drugs Dermatol. 2012;11(1):38-45.
Adjunctive Use of a Facial Moisturizer SPF 30 Containing Ceramide Precursor Improves Tolerability of Topical Tretinoin 0.05%: A Randomized, Investigator-Blinded, Split-Face Study
Methods:This was a randomized, investigator/evaluator-blinded, split-face comparison in subjects with healthy skin. Subjects applied tretinoin cream 0.05% once daily to the whole face and Cetaphil® Dermacontrol Moisturizer (CDM) once daily to one side of the face based on randomization. Tolerability, perference and skin hydration were evaluated at each week, and a cosmetic acceptability questionnaire regarding CDM was completed at the end of the study.
Results: The majority (about 83% to 86%) of subjects experienced skin irritations on both sides of their face, though predominantly mild for the CDM + tretinoin treated side. Tolerability preferences favored the CDM+tretinoin sides. Adjunctive use of CDM with a topical tretinoin cream improves tolerance of the treatment.
J Drugs Dermatol. 2012;11(9):1104-1107.
Neocollagenesis in Deep and Superficial Dermis by Combining Fractionated Q-Switched ND:YAG 1,064-nm With Topical Plant Stem Cell Extract and N-Acetyl Glucosamine: Open Case Series
Kavita Beri MDa and Sandy S. Milgraum MDb| |
METHOD: Six healthy females (Skin types III - V) were selected for the study with mean average age of 56 years +/- 11 years. The rhytides on the face and neck were assessed using a comprehensive grading scale. Patients were then divided into two groups, one received only laser treatment with the fractionated QSW 1,064 nm laser and the other group received combined treatment with the laser and topical. Patients were assessed again at 4 and 8 weeks.
RESULTS: We observed an enhanced anti-aging effect of the laser in the patients with combined treatment.
DISCUSSION: Understanding the effect of this novel laser therapy on human stem cells and investigating the basis of its synergistic effect with plant stem cell extract and NAG will lead us to better understand stem cell activity. Non-ablative tissue regeneration is the next step in providing optimal anti-aging treatments.
J Drugs Dermatol. 2015;14(11):1342-1346.
A Prospective, Neurophysiologic Comparative Study to Assess the Efficacy and Duration of Effect of IncobotulinumtoxinA and AbobotulinumtoxinA in the Treatment of Crow’s Feet
Anastasia Saybel MD,a Ada Artemenko MD PhD,b Sergei Nikitin MD PhD,c and Alexei Kurenkov MD PhDd| |
J Drugs Dermatol. 2015;14(11):1291-1296.
Mary P. Lupo MD FAAD| |
Stabilized Hyaluronic Acid-based Gel of Non-animal Origin for Skin Rejuvenation: Face, Hand, and Decolletage
Meike Streker MD, Tilmann Reuther MD, Nils Krueger MD PhD, and Martina Kerscher MD| |
OBJECTIVE: To assess the efficacy and safety of a stabilized HA-based gel of non-animal origin manufactured using the patented NASHA® technology (Restylane® Vital Light, Q-Med AB, Uppsala, Sweden) administered using a pre-filled micropuncture injector device for rejuvenation of the skin.
METHODS: Three treatment sessions 4 weeks apart were performed on one side of the face, the dorsum of one of the hands and one side of the decolletage, leaving the other side untreated. Skin quality was assessed via blinded live evaluation and subject satisfaction by questionnaire. Aesthetic change was evaluated independently by the subject and a blinded evaluator. Subjects were followed up to week 36.
RESULTS: Thirty subjects aged 40–65 years were enrolled. Overall skin quality across all three treatment areas was judged to be improved on the treated side in over 80% of subjects throughout the study. Significant aesthetic improvements on the treated sides were observed at all visits, with the exception of the decolletage at week 36.
CONCLUSIONS: This was the first study that used a micropuncture injector device for injection of NASHA gel, and reveals that this is a promising treatment option for rejuvenation of the skin.
J Drugs Dermatol. 2013;12(9):990-994.
A Two-Center, Open-Label, Randomized, Split-Face Study to Assess the Efficacy and Safety of One Versus Three Intradermal Injection Sites of AbobotulinumtoxinA in the Treatment of Lateral Periocular Rhytides
Sabrina G. Fabi MD,a Hema Sundaram MD,b Isabella Guiha BS,a and Mitchel P. Goldman MDa,| |
OBJECTIVE: To determine the efficacy of one versus three injection sites of AbobotulinumtoxinA (ABO) in the treatment of lateral canthal rhytides.
METHODS: This was a two-center, evaluator-masked, 120 day study in which 40 patients with moderate to severe hyperdynamic lateral canthal rhytides at maximal contracture were randomized to receive one injection of 36 Units of ABO into the middle of the lateral orbital rhytides on one side, with the contralateral side treated with the same total dose of ABO, divided into three intradermal injections of 12 Units each, along the lateral canthal area. A blinded evaluator assessed lateral orbital rhytides at rest and maximal contraction at baseline, 7, 42, 90, and 120 days post treatment. Standardized digital photography and subject self- assessment were performed at each visit.
RESULTS: No statistically significant difference was seen at any visit between sides treated with one injection and those treated with three injections in any evaluation category. There was no difference in adverse events between the two sides.
CONCLUSION: Sites treated with three injections of ABO showed no statistically significant difference from those treated with one injection.
J Drugs Dermatol. 2013;12(8):932-937.
Evan A. Rieder MD,a Euphemia W. Mu MD,a and Jeremy A. Brauer MDa,b,c| |
J Drugs Dermatol. 2015;14(9):1023-1026.
Jean Carruthers MD FRCSC FRC (OPHTH)a and Alastair Carruthers MD MRCP FRCPCb| |
J Drugs Dermatol. 2014;13(suppl 1):s7-s11.
Subhash J. Saxena PhD,a Deysi Duque MS,b and Michael J. Schirripa PhDb| |
METHODS: 85 adult females ages 35-65 with Fitzpatrick skin types I through IV applied the test neck cream twice daily for a 3-month study period. Screening was conducted at Baseline, 2, 30, 60, and 90 days via a virtual trial. Subjects rated satisfaction in each of 4 anti-aging categories including hydration, texture, appearance of wrinkles, and appearance of laxity as well as three product attributes including application, feel, and smell.
RESULTS: Improvement was statistically significant for all measured categories (hydration, texture, appearance of wrinkles, and appearance of laxity) with 94% of study subjects noting improvement in one or more of the measured categories. Further, the quantity of “Satisfied” and “Highly Satisfied” assessments increased 8-fold from baseline with a 94x increase in the quantity of “Highly Satisfied” assessments.
DISCUSSION: The results demonstrate the product’s rapid and continuing ability to improve the self-perceived signs of aging in the neck area including improvement in skin texture on the neck and a reduction in the appearance of wrinkles and laxity along the jawline. Future studies are recommended to determine the primary action mechanisms and to assess the degree of improvement by blinded physician assessment.
J Drugs Dermatol. 2015;14(9):997-1002.
Improvement of Atrophic Acne Scars in Skin of Color Using Topical Synthetic Epidermal Growth Factor (EGF) Serum: A Pilot Study
Marie Alexia Stoddard BS,a Jennifer Herrmann MD,b,c,d Lauren Moy MD,e and Ronald Moy MDb,f| |
BACKGROUND: Atrophic scarring in skin of color is a common, permanent, and distressing result of uncontrolled acne vulgaris. Ablative lasers and chemical peels are frequently used to improve the appearance of atrophic scars, primarily through the stimulation of collagen and elastin; however, these treatment modalities are associated with risks, such as dyspigmentation and hypertrophic scarring, especially in patients with darker skin.
OBJECTIVE: We evaluated the efficacy of topically applied synthetic epidermal growth factor (EGF) serum in reducing the appearance of atrophic acne scars in skin of color.
METHODS: A single-center clinical trial was performed on twelve healthy men and women (average age 32.5) with Fitzpatrick Type IV-V skin and evidence of facial grade II-IV atrophic acne scars. Subjects applied topical EGF serum to the full-face twice daily for 12 weeks. Scar improvement was investigated at each visit using an Investigator Global Assessment (IGA), a Goodman grade, clinical photography, and patient self-assessment.
RESULTS: Eleven subjects completed the trial. Compared to baseline, there was an improvement in mean IGA score from 3.36 (SEM = 0.15) to 2.18 (SEM = 0.33). Mean Goodman grade was reduced from 2.73 (SEM = 0.19) to 2.55 (SEM = 0.21). Of the eleven pairs of before and after photographs, nine were correctly chosen as the post-treatment image by a blind investigator. On self-assessment, 81% reported a “good” to “excellent” improvement in their scars compared to baseline (P = 0.004).
CONCLUSION: Topical EGF may improve the appearance of atrophic acne scars in skin of color. Additional, larger studies should be conducted to better characterize improvement.
J Drugs Dermatol. 2017;16(4):322-326.
Rachel Seidel BAa,c and Ronald Moy MD FAADb,c| |
OBJECTIVE: The aim of this study was to evaluate the ability of the CO2 facial to oxygenate the skin.
METHODS AND MATERIALS: Twelve patients were enrolled in this split-face study. They were treated one week apart with a CO2 facial on one side of the face and particle-free microdermabrasion on the other. Measurements of transcutaneous oxygen tension (tcPO2) were recorded at baseline and after each treatment. Statistical significance was assessed by comparing the average tcPO2 difference in mmHg following microdermabrasion and after a carbon dioxide facial using a 1-tailed paired t-test (α = 0.05).
RESULTS: The average increase in tcPO2 after CO2 facial treatment was statistically significantly greater (p = .0252) than after microdermabrasion.
CONCLUSION: Carbon dioxide facials improve skin oxygenation immediately following treatment, attributable to the generation of an artificial Bohr effect.
J Drugs Dermatol. 2015;14(9):976-980.
A High-Potency, Multimechanism Skin Care Regimen Provides SignificantAntiaging Effects: Results From a Double-Blind, Vehicle-Controlled Clinical Trial
Patricia K. Farris MD, Brenda L. Edison BA, Irina Brouda MA, Ronni L. Weinkauf PhD, andBarbara A. Green RPh MSPatricia K. Farris MD,a Brenda L. Edison BA,b Irina Brouda MA,b Ronni L. Weinkauf PhD,b and Barbara A. Green RPh MSb| |
J Drugs Dermatol 2012;11(12):1447-1454.
A Split-Face Assessment of the Synergistic Potential of Sequential Q-Switched Nd:YAG Laser and 1565 nm Fractional Nonablative Laser Treatment for Facial Rejuvenation in Fitzpatrick Skin Type II-V Patients
Girish Munavalli MD MHS FAAD FACMS| |
Consensus Recommendations on the Use of Injectable Poly-L-Lactic Acid for Facial and Nonfacial Volumization
Danny Vleggaar MD,a Rebecca Fitzgerald MD,b Z. Paul Lorenc MD FACS,c J. Todd Andrews MD,d Kimberly Butterwick MD,e Jody Comstock MD,f C. William Hanke MD,g T. Gerald O’Daniel MD FACS,h Melanie D. Palm MD MBA,i Wendy E. Roberts MD,j Neil Sadick MD,k and Craig F. Teller MDl| |
J Drugs Dermatol. 2014;13(suppl 4):s44-s51.
Efficacy of Cream-Based Novel Formulations of Hyaluronic Acid of Different Molecular Weights in Anti-Wrinkle Treatment
Tatjana Pavicic,b Gerd G. Gauglitz,b Peter Lersch,a Khadija Schwach-Abdellaoui,c Birgitte Malle,c Hans Christian Korting,b Mike Farwickaa| |
Background: Due to its strong water-binding potential, hyaluronic acid (HA) is a well-known active ingredient for cosmetic applications. Native HA is proposed to help the skin to retain and maintain elasticity, turgor and moisture.
Objective: To observe the efficacy of topical application of 0.1% hyaluronan formulations of different molecular weights (MW) (50, 130, 300, 800 and 2000 kDa, respectively) in the periocular area as anti-wrinkle treatment.
Material and Methods: Seventy-six female subjects between 30 and 60 years of age with clinical signs of periocular wrinkles applied one of the formulations twice-daily to the area of interest in a randomized fashion for 60 days. Around the other eye, a vehicle control cream was applied. Measurements of skin hydration and skin elasticity were performed before treatment, 30 and 60 days thereafter. At similar time points negative replicas were taken and evaluated by semi-automated morphometry.
Results: All HA-based creams utilized in this study demonstrated a significant improvement in skin hydration and overall elasticity values (R2) when compared to placebo. Measurements of wrinkle depth using mean roughness (Ra) and maximum roughness (Rz) values revealed significant improvement in the 130 and the 50 kDa HA group after 60 days of treatment compared to placebo-treated area.
Conclusion: Topical application of all 0.1% HA formulations used in this study led to significant improvement in skin hydration and elasticity. Application of low-molecular-weight (LMW) HA was associated with significant reduction of wrinkle depth, which may be due to better penetration abilities of LMW HA.
J Drugs Dermatol. 2011;10(9):990-1000.
Reduced Appearance of Under-eye Bags With Twice-daily Application of Epidermal Growth Factor (EGF) Serum: A Pilot Study
Rachel Seidel BAa and Ronald L. Moy MD FAADa,b| |
OBJECTIVE: We studied the ability of a topical serum containing epidermal growth factor (EGF) to minimize the appearance of under-eye bags.
METHODS: A single-center clinical trial was performed on eighteen volunteer male and female patients with under-eye bags. Subjects applied EGF serum to the infraorbital area twice daily for 12 weeks. At each visit, subjects were evaluated using clinical photography and written self-assessment. A grade on the Merz Infraorbital Hollowness Scale was also given and two independent, blind investigators assigned an Investigator’s Global Assessment (IGA) score. At the trial’s end, patients shared their final evaluation and perception of results with a questionnaire.
RESULTS: Sixteen subjects completed the trial. The final average Merz grade was 1.63 (SEM = .273), statistically significantly lower than the mean baseline average of 2.06 (SEM = .232) (P = .0019). A reduction in average IGA score was also significant (P < .0001). Average initial IGA was 2.75 (SEM = .270) and average final IGA was 2.00 (SEM = .310). All but two subjects reported improvement at the final visit. Improvement was quantified as 76-100% by two subjects, 50-75% by three subjects, and 25-49% by nine subjects. Eleven subjects classified their under-eye bags as milder at the end of the trial compared to the first visit. Seven subjects reported greater satisfaction with their overall facial appearance. Of the subjects who had used other topical treatments in the past, two reported the serum to be “significantly better” and four said it was “better” in treating their under-eye bags.
CONCLUSION: Our results offer evidence that topical EGF can reduce the appearance of under-eye bags.
J Drugs Dermatol. 2015;14(4):405-410.
The projections of increases in the number of skin of color patients over the next several decades, necessitates expertise in cultural competence for health care providers. Acquiring competency begins with practitioners reflecting on their self identity and personal beliefs. Additionally, understanding African-American cultural habits and practices and their impact on disease is critically important. We review, in this article, the fundamentals of becoming cultural competent. Patients are best served when their physician embraces their culture, their view of the health care system as well as habits and practices.
J Drugs Dermatol. 2012;11(4):460-465.
The Mechanisms and Potential Impact of Stem Cell Activation in Skin Rejuvenation: An Evidence-Based Analysis
Hema Sundaram MD| |
Stem cells can propagate indefinitely in an undifferentiated state; or, with appropriate signals, differentiate into various types of mature cells. Strong interest in stem cell therapies for degenerative diseases has extended to skin aging, itself a degenerative process. This article reviews mechanisms of skin aging, and enables an evidence-based approach to topical skin rejuvenation - specifically, to formulations labeled as stem cell products.
J Drugs Dermatol. 2017;16(4):378-384.
Pilot Evaluation of a Novel Topical Formulation Containing High Level, Cholesterol-Dominant, Physiological Lipids for Specific Targeting of Skin Barrier Deficits in Aging Skin
Hema Sundaram MD,a Ana Du BS,b Margarita Yatskayer MS,b Stephen Lynch PhD,b Yevgeniy Krol,c and Christian Oresajo PhDb| |
Martina Kerscher MD,a Yana Yutskovskaya MD,b and Timothy Corcoran Flynn MDc| |
J Drugs Dermatol. 2013;12(6):e111-e120.
Cosmetic Use of AbobotulinumtoxinA in Men: Considerations Regarding Anatomical Differences and Product Characteristics
Jason D. Bloom MD,a Jeremy B. Green MD FAAD,b Whitney Bowe MD,c Erika von Grote PhD,d and Alessandra Nogueira MDd| |
Among the product options available in the US, Dysport® (abobotulinumtoxinA) (Galderma Laboratories, L.P., Fort Worth, Texas) is unique in that its recommendations for reconstitution provide the clinician with 2 different final product concentrations. The flexibility provided by a variable dose may be a valuable tool for tailoring treatments to male patient-specific needs, which may include a more conservative outcome, maintaining a certain degree of muscle activity and expressivity. Achieving a conservative outcome may be the key to a positive experience for the male patient.
J Drugs Dermatol. 2016;15(9):1056-1062.
Vic A. Narurkar MD,a Sabrina G. Fabi MD FAAD FAACS,b Vivian W. Bucay MD FAAD,c Ruth Tedaldi MD,d Jeanine B. Downie MD,e Joshua A. Zeichner MD,f Kimberly Butterwick MD,g Amy Taub MD,h Kuniko Kadoya PhD,i Elizabeth T. Makino BS MBA CCRA,i Rahul C. Mehta PhD,i and Virginia L. Vega PhDi| |
SkinMedica’s HA5 Rejuvenating Hydrator (SkinMedica Inc., an Allergan company, Irvine, CA) promotes restoration of endogenous epidermal HA homeostasis and provides instant smoothing and hydration of the skin. These dual benefits are accomplished through the combination of 2 breakthrough technologies: 1) a unique blend of actives powered by SkinMedica proprietary flower-derived stem cell extract that restores the endogenous production of HA; and 2) a proprietary mix of 5 HA forms that plump the skin, decreasing the appearance of fine lines/wrinkles.
Pre-clinical studies demonstrated that HA5 induces expression of key epidermal differentiation and barrier markers as well as epidermal HA synthases. A decrease expression of hyaluronidases was also observed upon HA5 application. Initial clinical studies showed that within 15 minutes of application, HA5 instantly improves the appearance of fine lines/wrinkles and skin hydration. Subjects that continue using HA5 (for 8 weeks) demonstrated significant improvements in fine lines/wrinkles, tactile roughness, and skin hydration. In summary, the blend of these 2 key technologies present in HA5 promotes restoration of endogenous epidermal HA while delivering instant smoothing effects.
J Drugs Dermatol. 2016;15(1 Suppl 2):s24-s37.
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