Volume 15 | Issue 9
Skin Barrier Health: Regulation and Repair of the Stratum Corneum and the Role of Over-the-Counter Skin Care
Thomas Lee MD and Adam Friedman MD|The epidermis functions as a physical barrier that separates the inner body from the outside environment. The outermost layer of the epidermis, the stratum corneum, plays a key role in maintaining this barrier. There are numerous biochemical changes that take place to and in the keratinocyte as it migrates from the bottom, or startum basale, to the top layer of the epidermis in order for this barrier to function appropriately. In addition, external and internal factors, such as irritants and underlying medical diseases, can also affect the stratum corneum, both of which can potentially lead to disruption of barrier function and ultimately skin pathology. In this article, we will review keratinocyte biology as it relates to the formation and function of the stratum corneum. We will also review stratum corneum structure, physiology, and the impact of chemical agents and defective stratum corneum components that can lead to skin disease. Finally, we will briefly discuss how moisturizers repair defects in the stratum corneum and restore barrier function.
J Drugs Dermatol. 2016;15(9):1047-1051.
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|The proportion of men seeking facial rejuvenation with botulinum neurotoxin type A (BoNTA) products is increasing. The number of male patients treated in the 5-year period between 2009 and 2014 grew by 25%. There is little clinical data supporting gender-specific efficacy with regard to dosing and injection placement in men. To nurture the confidence associated with treatment of male patients, clinicians are in need of more informational materials to develop their evaluation and treatment strategies. Three BoNTA products are currently available in the United States (US) for treatment of the upper face. The varying potency of the different BoNTA formulations is reflected by disparate dose-response characteristics, meaning they are not interchangeable for injection purposes. Clinicians who are familiar with the characteristics of all the BoNTA options will be equipped with the necessary tools to provide their male patients with a desired outcome.
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.
Patient Reported Outcomes from HIV Facial Lipoatrophy Treatment With a Volumizing Hyaluronic Acid Filler: A Prospective, Open-Label, Phase I and II Study
Derek Ho BSa,b and Jared Jagdeo MD MSa,b,c|BACKGROUND: Human immunodeficiency virus (HIV) facial lipoatrophy (FLA) is associated with the use of highly active antiretroviral therapy (HAART) and HIV disease. HIV FLA is primarily characterized by midface (cheeks and temples) volume loss, resulting in a “sunken” and aged appearance. Filler agents for treatment of HIV FLA can provide midface volumization and improve quality-of-life (QOL). A 20 mg/ml hyaluronic acid (HA) filler (Juvéderm Voluma® XC, Allergan plc, Irvine, CA) may provide an immediate, natural appearing facial enhancement outcome in one treatment. We hypothesized that this HA filler for treatment of HIV FLA is safe and efficacious and may help improve patients’ QOL.
OBJECTIVE: To provide patient reported outcomes from HA filler for treatment of HIV FLA and suggest recommendations on use of validated QOL outcome measures to assess patient concerns specific to HIV FLA.
METHODS: This was a prospective, open-label, phase I and II study to evaluate patient reported outcomes, in addition to safety and efficacy, of this HA filler for treatment of HIV FLA in 20 subjects at the Sacramento Veterans Affairs Medical Center, Mather, CA (ClinicalTrials.gov NCT02342223). Outcome measures include the Dermatology Life Quality Index (DLQI) and a subject satisfaction questionnaire (SSQ).
RESULTS: Nineteen subjects completed the 12-month follow-up. There was no significant improvement of DLQI score. Subject comments revealed high degree of satisfaction and there were no negative comments on the SSQ.
CONCLUSIONS: In this study, we report that all subjects that completed this study were satisfied and had subjective improvement of their QOL post-treatment. We recommend against use of DLQI in the future as it may not fully encompass the emotional and mental health aspects that may be affected from HIV FLA. We recommend use of the Facial Appearance Inventory (FAI) and FACE-Q in future studies for HA filler treatment of HIV FLA.
J Drugs Dermatol. 2016;15(9):1064-1069.
Microneedling Prior to Levulan PDT for the Treatment of Actinic Keratoses: A Split-Face, Blinded Trial
James M. Spencer MD MSa,b and Scott A. Freeman PAb|INTRODUCTION: Photodynamic Therapy (PDT) with topical Levulan is an approved and efficacious method for treating actinic keratoses. This therapy depends on the ability of the Levulan (delta amino levulinic acid) to penetrate the stratum corneum and enter the cells of the epidermis. Microneedling is an increasing popular cosmetic therapy in which an array of tiny needles is used to make holes in the epidermis and presumably induce a wound healing cascade that leads to cosmetic improvement of the skin. We were interested to know if prior microneedling would enhance the penetration of topical Levulan and thus enhance the PDT treatment, and if a cosmetic improvement beyond the PDT alone would be seen when it is used in conjunction with microneedling.
METHODS: 20 patients each with at least 4 non hyperkeratotic AKs on each side of their face were enrolled. All patients were randomized to receive multiple passes with a microneedling device to ½ of their face, left or right, followed by application of Levulan to the entire face. The Levulan was allowed to incubate 1 hour followed by exposure to blue light (Blu U) for 1000 seconds.
RESULTS: 19 patients completed the study with 4-month follow up. The mean percentage reduction in AKs was 89.3% on the microneedling side versus 69.5% on the PDT alone side, a significant difference. A physician’s global cosmetic assessment was performed based on Canfield Visia photographs: 15 of the 19 patients had a noticeable improved cosmetic appearance on one side of the face versus the other, and in 13 of these patients the improved side was the microneedled side.
DISCUSSION: Prior microneedling significantly enhances the effect of Levulan PDT. It also seems to provide a cosmetic benefit above and beyond the PDT alone. It was safe and well tolerated in this study.
J Drugs Dermatol. 2016;15(9):1072-1074.
Annie Chiu MD,a Sabrina Fabi MD,b Steven Dayan MD,c and Alessandra Nogueira MDd|The shape and fullness of the lips have a significant role in facial aesthetics and outward appearance. The corrective needs of a patient can range from a subtle enhancement to a complete recontouring including correction of perioral rhytides. A comprehensive understanding of the lower face anatomical features and injection site techniques are foundational information for injectors. Likewise, the choice of filler material contributes to the success of the injection techniques used, and facilitates a safe, effective, and natural appearing outcome. The small-particle HA 20 mg/mL with lidocaine 0.3% (SP-HAL, Restylane® Silk; Galderma Laboratories, Fort Worth, Texas) is indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytides. Due to its rheological properties and smaller particle size, SP-HAL is a well-suited filler for the enhancement and correction of lip shape and volume, as well as for the correction of very fine perioral rhytides. This work is a combined overview of techniques found in the current literature and recommendations provided by contributing authors.
J Drugs Dermatol. 2016;15(9):1076-1082.
Efficacy and Safety of IncobotulinumtoxinA in Asian Subjects: A Pooled Analysis of Clinical Trials in the Treatment of Glabellar Frown Lines
Kyle Seo MD PhD,a,b Tsen-Fang Tsai MD,c Yates Yen-Yu Chao MD,d Greg J. Goodman FACDe,f|BACKGROUND: Owing to differences in facial anatomy and cultural beauty ideals, dose adaptations are often necessary when administering botulinum toxin type A to Asians and non-Asians. Objective: To assess potential differences in the efficacy and safety of incobotulinumtoxinA in Asian and non-Asians.
METHODS: Efficacy data were pooled from several Phase II/III trials that used 20 U incobotulinumtoxinA to treat glabellar frown lines in Asian subjects. The variable of interest was investigator-assessed improvement in scores on the 4-point Facial Wrinkle Scale from baseline to days 30, 60, 90, and 120. Subjects with a 1-point improvement were considered ‘responders’. Data were also assessed for treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest among a pool of incobotulinumtoxinA safety studies.
RESULTS: Four trials were pooled, comprising 19 Asian and 563 non-Asian subjects. At maximum frown on day 30, 100% of Asians and 87% of non-Asians were responders; by day 120, values were 37% and 40%, respectively. At rest on day 30, 63% of Asians and 56% of non-Asians were responders. Corresponding values for day 120 were 11% and 25%. The mean change in score on the Facial Wrinkle Scale from baseline over time was similar in both groups. Very few adverse events occurred. Overall, treatment-emergent adverse events were lower amongst Asians than non-Asians.
CONCLUSIONS: Compared with non-Asians, a trend towards slightly higher responses was observed in Asians at maximum frown. There were no clinically relevant differences in the safety of incobotulinumtoxinA when administered to Asian and non-Asian subjects.
J Drugs Dermatol. 2016;15(9):1084-1087.
Patrick Micheels MD,a Stéphanie Besse MD,b and Didier Sarrazin MDc|BACKGROUND: Hyaluronic acid (HA) fillers are commonly used for enhancement of lips, and for softening fine lines and correcting skin depressions. Objective: This study sought to investigate whether the Vycross™ technology used for Volbella™ gel resulted in a cohesive gel, as documented in our previous studies with three other HA fillers (Restylane® NASHA™ [Q-MED, Uppsala, Sweden], Esthélis® Basic CPM™ [Anteis SA, Geneva, Switzerland], and Juvéderm® Ultra 3 using Hylacross technology [Allergan, Irvine, CA, USA]).
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.
An Open Label Clinical Trial of a Peptide Treatment Serum and Supporting Regimen Designed to Improve the Appearance of Aging Facial Skin
Zoe Diana Draelos MD,a Tatiana Kononov BS MBA,b and Theresa Fox BSb|A 14-week single-center clinical usage study was conducted to test the efficacy of a peptide treatment serum and supporting skincare regimen in 29 women with mild to moderately photodamaged facial skin. The peptide treatment serum contained gamma-aminobutyric acid (GABA) and various peptides with neurotransmitter inhibiting and cell signaling properties. It was hypothesized that the peptide treatment serum would ameliorate eye and facial expression lines including crow’s feet and forehead lines. The efficacy of the supporting skincare regimen was also evaluated. An expert investigator examined the subjects at rest and at maximum smile. Additionally, the subjects completed self-assessment questionnaires. At week 14, the expert investigator found a statistically significant improvement in facial lines, facial wrinkles, eye lines, and eye wrinkles at rest when compared to baseline results. The expert investigator also found statistically significant improvement at week 14 in facial lines, eye lines, and eye wrinkles when compared to baseline results at maximum smile. In addition, there was continued highly statistically significant improvement in smoothness, softness, firmness, radiance, luminosity, and overall appearance at rest when compared to baseline results at the 14-week time point. The test regimen was well perceived by the subjects for efficacy and product attributes. The products were well tolerated with no adverse events.
J Drugs Dermatol. 2016;15(9):1100-1106.
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Melissa Meland BS,a Chris Groppi MS,a and Z. Paul Lorenc MDb|BACKGROUND: Calcium hydroxylapatite with integral lidocaine, CaHA (+), received FDA approval in 2015 and CE mark approval in 2016. This formulation has been associated with significant pain reduction compared to CaHA. In a previous rheometry study, CaHA without lidocaine demonstrated higher viscosity and elasticity when compared with hyaluronic acid fillers. Study Objective: To compare the rheological properties of CaHA (+) lidocaine to CaHA without lidocaine and to compare the rheological measures of CaHA (+) to 5 cross-linked hyaluronic acid (HA) fillers with integral 0.3% lidocaine.
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.
Alan B. Fleischer Jr. MDa and Isabelle Raymond PhDb|Econazole nitrate topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. The symptom of itch or pruritus was evaluated in two randomized, double-blind, parallel-group, vehicle-controlled, multicenter Phase III studies in which econazole foam was compared with foam vehicle in subjects with interdigital tinea pedis. A thin, uniform layer of study treatment was applied once daily to all clinically affected interdigital regions of both feet for four weeks. At baseline, at least 69% of all subjects had moderate to severe itch. Throughout the duration of both studies, numerically econazole foam was numerically superior to vehicle in achieving absence of itch. After the cessation of treatment, from day 29, itching continues to improve until day 43 in the active treatment group, whereas there is no evident continued improvement within the vehicle foam groups. At day 43, in the active treatment groups, 83% in Study 1 and 71% in Study 2 achieved complete absence of itching. Using less stringent criteria, for the econazole nitrate foam arm, achieving no itch or mild itch (0 or 1), in Study 1, 95% and 86.8% in Study 2 achieved this outcome. Tolerability of the products was excellent with few treatment-related adverse events. In summary, econazole foam decreased the burden of itch as early as day 8 in patients with interdigital tinea pedis, and this improvement continued after cessation of treatment.
J Drugs Dermatol. 2016;15(9):1111-1114.
Efinaconazole 10% and Tavaborole 5% Penetrate Across Poly-ureaurethane 16%: Results of In Vitro Release Testing and Clinical Implications of Onychodystrophy in Onychomycosis
Chris G. Adigun MD,a Tracey C. Vlahovic DPM,b Michael B. McClellan MS,c Kailas D. Thakker PhD,c Ryan R. Klein PhD,c Tuan A. Elstrom BS,d and Daniel B. Ward Jr. MD FAADd|BACKGROUND: Poly-ureaurethane has been previously described for the management of dry, brittle, and in general, dystrophic nails. The polymer yields a waterproof, breathable barrier to protect the nail plate and prevent further damage to the nail, while regulating transonychial water loss (TOWL). Because nail dystrophy and dessication are contributing factors to onychomycosis, a barrier that protects the nail but also allows a topical antifungal to permeate its shield is potentially an advantageous combination. Oral antifungals such as terbinafine, itraconazole, and fluconazole, as well as the newer topical antifungals efinaconazole and tavaborole (although formulated to penetrate the nail unit and work with the porosity and inherent electrical charge of the nail plate), do not take into account nail damage that has been created from years of harboring a dermatophyte infection. Up to 50% of cases presumed to be onychomycosis are in fact onychodystrophy without fungal infection, and laboratory testing for fungus should be obtained prior to initiating antifungal treatment. Whether a nail has onychomycosis, or onychodystrophy due to other causes, barrier function and structural integrity are compromised in diseased nails, and should be addressed. A poly-ureaurethane barrier that protects against wetting/drying, fungal reservoirs, and microtrauma, followed by the addition of oral or topical antifungals after laboratory fungal confirmation may optimize outcomes in the treatment of onychomycosis.
OBJECTIVE: The purpose of this work was to determine through in vitro release testing (IVRT) whether poly-ureaurethane 16% allows for penetration of efinaconazole 10% or tavaborole 5%. Results could spur subsequent clinical studies which would have implications for the addition of an antifungal based on fungal confirmation, after addresssing the underlying nail dystrophy primarily.
METHODS: A vertical diffusion cell system was used to evaluate the ability of efinaconazole 10% and tavaborole 5% to penetrate across poly-ureaurethane 16%. The diffusion cells had a 1.0 cm2 surface area and approximately 8 mL receptor volume. Poly-ureaurethane 16% was applied to a 0.45 μm nylon membrane and allowed to dry before use. Efinaconazole 10% or tavaborole 5% was then applied to the poly-ureaurethane 16% coated membrane, and samples were pulled from the receptor chamber at various times. Reverse phase chromatography was then used to assess the penetration of each active ingredient across the membrane.
RESULTS: The flux and permeability of efinaconazole or tavaborole across poly-ureaurethane 16% were determined from efinaconazole 10% or tavaborole 5%, respectively. The flux and permeability of efinaconazole were determined to be 503.9 +/- 31.9 μg/cm2/hr and 14.0 +/- 0.9 nm/sec. The flux and permeability of tavaborole were determined to be 755.5 +/- 290.4 μg/cm2/hr and 42.0 +/- 16.1 nm/sec.
CONCLUSION: In addition to the treatment of onychoschizia, onychorrhexis, and other signs of severe dessication of the nail plate, a barrier that regulates TOWL should be considered in the management onychomycosis to address barrier dysfunction and to promote stabilization of the damaged nail. Previously published flux values across the nail are reported to be 1.4 μg/cm2/day for efinaconazole and 204 μg/cm2/day for tavaborole. These values are substantially lower than the herein determined flux for both molecules across poly-ureaurethane 16%. A comparison of the data suggests that poly-ureaurethane 16%, if used prior to efinaconazole or tavaborole, would not limit the ability of either active ingredient to access the nail, and therefore, would be unlikely to reduce their antifungal effect. Onychodystrophy is inherent in, and often precedes onychomycosis, and consideration should be given for initiation of treatment in the same sequence: stabilizing and protecting the nail plate barrier primarily, and subsequently adding oral or topical antifungals after laboratory confirmation. Future clinical studies will be needed to determine combination efficacy for in vivo use.
J Drugs Dermatol. 2016;15(9):1116-1120.
Aaron S. Farberg MD,a Adam C. Rigel MMS MS,b and Darrell S. Rigel MD MSc|The American Academy of Dermatology and dermatologists
Breanne Mordorski BA,a Adam Friedman MD,b George Han MD PhDc|Cutaneous anaplastic large cell lymphoma (ALCL) is an uncommon diagnosis that may either present as a primary cutaneous process or develop secondary to systemic disease. It is imperative to distinguish between these two entities due to differences in treatment recommendations and prognosis. Here, their salient features will be reviewed. It is also important that clinicians recognize atypical clinical morphologies of cutaneous ALCL, including pustular lesions, which may masquerade as infectious or other inflammatory conditions, thereby delaying the onset of treatment. In this report, we present a case of secondary cutaneous ALCL associated with an atypical pustular morphology and an aggressive, fatal course.
J Drugs Dermatol. 2016;15(9):1132-1135.
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|Current concepts of facial aging propose that volume losses of bone and fat in specific compartmentalized areas are the primary and the most important causes of the characteristic changes seen in the aging face. The authors propose that the use of Radiesse in the supra-periosteal space of the temple, zygomatic arch, anterior cheek, pyriform aperture, and pre-jowl sulcus most effectively and most efficiently corrects these volume losses, and therefore best helps to restore a youthful appearance. Placement of filler directly on bone produces a lifting effect on all of the overlying tissues as a single unit which the authors term “composite volumization”.
J Drugs Dermatol. 2016;15(9):1136-1141.
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|Although infrequent, non-inflammatory nodules are potential complications associated with dermal filler injections. There is a lack of consensus in the literature regarding potential treatments to help resolve nodules associated with calcium hydroxylapatite (CaHA) filler injections. This case report describes the successful treatment of a non-inflammatory nodule related to CaHA injection using a combination of 5-fluorouracil, dexamethasone, and triamcinolone.
J Drugs Dermatol. 2016;15(9):1142-1143.
2016 Arte Poster Competition First Place Winner: Circadian Rhythm and UV-Induced Skin Damage: An In Vivo Study
Linna Guan BS,a,* Amanda Suggs MD,a,* Sayeeda Ahsanuddin BS,a Madeline Tarrillion DO,a Jacqueline Selph MD,a Minh Lam PhD,a and Elma Baron MDa,b,c|Exposure of the skin to ultraviolet (UV) irradiation causes many detrimental effects through mechanisms related to oxidative stress and DNA damage. Excessive oxidative stress can cause apoptosis and cellular dysfunction of epidermal cells leading to cellular senescence and connective tissue degradation. Direct and indirect damage to DNA predisposes the skin to cancer formation. Chronic UV exposure also leads to skin aging manifested as wrinkling, loss of skin tone, and decreased resilience. Fortunately, human skin has several natural mechanisms for combating UV-induced damage. The mechanisms operate on a diurnal rhythm, a cycle that repeats approximately every 24 hours. It is known that the circadian rhythm is involved in many skin physiologic processes, including water regulation and epidermal stem cell function. This study evaluated whether UV damage and the skin’s natural mechanisms of inflammation and repair are also affected by circadian rhythm. We looked at UV-induced erythema on seven human subjects irradiated with simulated solar radiation in the morning (at 08:00 h) versus in the afternoon (at 16:00 h). Our data suggest that the same dose of UV radiation induces significantly more inflammation in the morning than in the afternoon. Changes in protein expression relevant to DNA damage, such as xeroderma pigmentosum, complementation group A (XPA), and cyclobutane pyrimidine dimers (CPD) from skin biopsies correlated with our clinical results. Both XPA and CPD levels were higher after the morning UV exposure compared with the afternoon exposure.
J Drugs Dermatol. 2016;15(9):1124-1130.
The Effects of a Daily Skincare Regimen on Maintaining the Benefits Obtained from Previous Chemical Resurfacing Treatments
Suzanne Bruce MD,a Wendy Roberts MD,b Craig Teller MD,c and Lora Colvan BSd|BACKGROUND: Chemical peels are versatile treatments that involve chemical exfoliation of the skin for cosmetic improvement. Deeper peels produce more significant results, but can be associated with longer healing time and potential complications. Novel chemical resurfacing treatments (AGE and MELA) were developed in Europe to produce skin resurfacing via controlled inflammation to promote cell regeneration with minimum negative effects associated with conventional peelings. The AGE Resurfacing regimen is indicated for the treatment of photoaging, and consists of multi-ingredient peeling solution with trichloroacetic acid, pyruvic acid, salicylic acid, mandelic acid, and lactobionic acid. The MELA Resurfacing regimen addresses hyperpigmentation concerns and contains mandelic acid, potassium azeloyl diglycinate, retinol, salicylic acid, phytic acid, lactobionic acid, and lactic acid. Results of previously conducted US clinical experience trial of AGE and MELA resurfacing protocols rated 81% of subjects with some level of improvement according to physician assessment.
OBJECTIVES: To evaluate whether a daily skin care regimen used for 12 weeks could maintain the benefits achieved with AGE and MELA chemical resurfacing treatments.
METHODS: Subjects who completed participation in the AGE and MELA skin resurfacing clinical trial were recruited to participate in a continuation trial and used a daily regimen of MDRejuvena facial products for 12 weeks. No other facial products were permitted. Physicians assessed the severity of individual skin parameters at baseline and week 12 and provided global assessment. Subjects assessed improvement of individual skin parameters at week 12 and provided an overall assessment.
RESULTS: Thirteen subjects participated in the 12-week continuation trial. According to the physician’s global assessment, all subjects demonstrated some level of improvement at week 12 compared to baseline. Physician assessment showed a decrease in severity of all skin parameters assessed at week 12 compared to baseline. According to the subject overall assessment at week 12, 11 of 12 subjects noted some level of improvement, 1 subject saw no improvement, and 1 subject did not provide an overall assessment. Mild to moderate improvement was observed by subjects in all individual skin parameters assessed except for skin discoloration.
CONCLUSIONS: The results of the continuation study demonstrate that use of a daily skin care regimen, which include combination of 2 various strengths of MDRejuvena Rejuvaphyl® Rejuvenating Complex: low strength (LS) and high strength (HS), not only maintains but can enhance the beneficial effects of skin resurfacing treatments for at least 12 weeks.
J Drugs Dermatol. 2016;15(9):1145-1150.
Mary P. Lupo MD FAAD|*Proceedings from a recent cosmetic dermatology conference, Cosmetic Bootcamp, Aspen, CO
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.