Volume 11 | Issue 1
Perry Robins MD|No abstract details for the moment.
Perry Robins MD|No abstract details for the moment.
Letter to the Editor: The New Face of Fillers: Integrating Evidence, Experience and a Little Imagination at the Next Frontier
Hema Sundaram MD|No abstract details for the moment.
News, Views and Reviews provides focused updates, topic reviews and editorials concerning the latest developments in dermatologic therapy.
Two Randomized, Controlled, Comparative Studies of the Stratum Corneum Integrity Benefits of Two Cosmetic Niacinamide ⁄ Glycerin Body Moisturizers vs. Conventional Body Moisturizers
Jeremy C. Christman MS,a Deborah K. Fix BS MBA,b Sawanna C. Lucus BS,a Debrah Watson BS,a Emma Desmier BS,a Rolanda J. Johnson Wilkerson PhD,a Charles Fixler MDb|Background and Objective: Despite numerous body moisturizers being available, cosmetic xerosis continues to be a leading skin problem for consumers. We performed two 35-day studies to evaluate the ability of a variety of body moisturizers containing various levels of oils/lipids, humectants, as well as other ingredients (e.g., niacinamide) to improve stratum corneum integrity.
Methods: 63 and 58 female subjects were enrolled and randomized in an incomplete block design to six of nine products (eight moisturizers or no treatment control) in studies 1 and 2, respectively. The primary endpoints included visual dryness by a qualified skin grader, skin hydration as measured by Corneometer, and barrier integrity as measured by transepidermal water loss (TEWL). The primary comparisons for the two niacinamide/glycerin moisturizers were to the other six moisturizers and to the no treatment control for each endpoint.
Results: The two niacinamide/glycerin moisturizers demonstrated an overall better solution towards rapid and prolonged improvement of cosmetic xerosis due to functional improvement of stratum corneum barrier function compared to no treatment and the other moisturizers tested.
Conclusions: These studies establish the benefit of including niacinamide in a body moisturizer to improve the integrity of the stratum corneum and thus reduce cosmetic xerosis over time.
J Drugs Dermatol. 2012;11(1):22-29.
Application of a Topical Biomimetic Electrical Signaling Technology to Photo-Aging: A Randomized, Double-Blind, Placebo-Controlled Trial of a Galvanic Zinc-Copper Complex
Jeannette Chantalat MS MBA, Elizabeth Bruning BSC LLB, Ying Sun PhD, Jue-Chen Liu PhD|Background: The first signs of facial skin photo-aging often occur in the skin of the periorbital area and include sagging, loss of firmness and definition, and sallowness. Epidermal wounds have been shown to alter the trans-epithelial electrical potential creating an electric signal that directs cell migration in epithelial wound healing; this electric field declines sharply with age. A topical galvanic zinc-copper complex, which couples elemental zinc and copper to create a biomimetic electric field, has demonstrated anti-inflammatory activity and extracellular matrix improvement in vitro, including collagen and elastin production.
Objectives: To evaluate the efficacy and tolerability of a galvanic zinc-copper complex on photo-aging parameters in a randomized, double-blind, placebo-controlled clinical trial.
Materials and Methods: In this eight-week study, women (40-65 years) with mild to moderate photo-aging were randomized to use placebo or 1 of 3 galvanic zinc-copper complex compositions (gel and activating moisturizer). Efficacy evaluations included clinical grading, specialized clinical imaging, and subject self-assessments performed at baseline, 15-30 minutes after product application and after 1, 2, 4, and 8 weeks. Tolerability was based on adverse events and clinical grading of irritation. Significance was set at P≤0.05 versus baseline and between treatment groups.
Results: The study was completed by 124 women. Compositions containing the galvanic zinc-copper complex showed statistically significant clinical improvements versus placebo and baseline rapidly (15-30 min) after application and through week 8. Clinical grading showed significant improvement versus placebo in skin radiance and under-eye dark circles 15-30 minutes after first application with continued improvement through week 8, and in overall photo-damage, fine lines, lifted appearance of the eyes, and under-eye wrinkles starting after two weeks and continuing through week 8. Test compositions were well tolerated.
Conclusion: This galvanic zinc-copper complex provided rapid and lasting improvements versus placebo in photo-aged skin, supporting its use in topical anti-aging formulations.
J Drugs Dermatol. 2012;11(1):30-37.
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|Background: Injections of botulinum toxin type A are commonly used to treat facial wrinkles; however, undesirable effects are associated with injections (e.g., pain, bruising, ptosis, immunogenicity, and needle aversion). To address these issues, RT001 Botulinum Toxin Type A Topical Gel is being developed for the treatment of lateral canthal lines.
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.
Nonanatomic Free Cartilage Batten Grafting With Second Intention Healing for Defects on the Distal NoseBackground: Defects of the distal nose, particularly the nasal ala, pose a reconstructive challenge due to the lack of loose adjacent tissue and proximity to a free margin.
Objective: We report our experience using nonanatomic free cartilage batten grafts in combination with second intention healing for nasal ala defects.
Methods: A retrospective study of distal nose defects repaired using nonanatomic free cartilage batten grafting with second intention healing was performed. Detailed data on the quality of the scar, post-operative complications, free margin distortion, functional impairments, and patient satisfaction were recorded. Digital images were also shown to an experienced fellowship-trained Mohs surgeon to assess the overall aesthetic outcome using a 5-point score ranging from poor to excellent.
Results: Sixteen subjects were included in the study. Complications were common, but minor. Five (~31%) subjects had subtle contour depressions, three (~18%) subjects had excessive granulation tissue, two (~12%) subjects had post-operative ear pain at the donor site lasting up to 10 days, and one (~6%) subject had a hypertrophic scar at the recipient site. There were two occurrences (~12%) of mild alar notching but no occurrences of significant alar margin distortion or nasal valve dysfunction. In terms of aesthetic outcome, seven (~43%) were assessed by an independent fellowship-trained Mohs surgeon as having excellent aesthetic outcomes, six (~38%) were very good, and three (~19%) were good. All sixteen subjects reported satisfaction on follow-up evaluation.
Conclusions: Nonanatomic free cartilage grafting with second intention healing allows for facile, single-step repair of nasal ala defects with high patient satisfaction and aesthetically pleasing results. This provides an attractive alternative to other flap techniques, skin grafting, and healing via secondary intention.
J Drugs Dermatol. 2012;11(1):46-50.
Tian-Hua Xu MD,a John ZS Chen MD,b Yuan-Hong Li MD,a Yan Wu MD,a Yao-Jia Luo MD,a Xing-Hua Gao MD,a Hong-Duo Chen MDa|
Background: L−ascorbic acid has been widely used to treat photo-aged skin. However, its aqueous formula is prone to oxidation. Therefore, a new formula that contains 23.8% L−ascorbic acid and a chemical penetration enhancer was developed.
Objective: Observe the efficacy and safety of topical 23.8% L−ascorbic acid serum on photo-aged skin.
Methods: Twenty Chinese women with photo-aged skin were enrolled in this split-face study. They were treated with topical L−ascorbic acid serum with iontophoresis on one side of the face once a day for 2 weeks; the other side of the face was spared treatment through participants´ self-control. Changes in photo-aged skin were evaluated using a global evaluation, an overall self-assessment, a spectrophotometer, the phase-shift rapid in vivo measurement of skin (PRIMOS) 3D, and a corneometer.
Results: Sixteen of 20 patients (80%) experienced a score decrease of 2 or 3 grades, according to the dermatologist. Fifteen patients (75%) rated their overall satisfaction as excellent or good. Dyspigmentation, surface roughness, and fine lines on the treated side improved significantly.
Conclusion: Topical 23.8% L−ascorbic acid serum is effective for the treatment of photo-aged skin and does not cause any obvious side effects.
J Drugs Dermatol.2012;11(1):51-56.
Treatment of Focal Axillary Hyperhidrosis Using a Long-Pulsed Nd:YAG 1064 nm Laser at Hair Reduction SettingsBackground and Objective: Axillary hyperhidrosis is a rather common idiopathic disorder of the eccrine sweat glands, which can interfere with daily activities and cause significant social distress. The effects of 1064 nm laser hair reduction on sweat production in a pilot study in patients with focal axillary hyperhidrosis are described.
Study Design/Materials and Methods: In a prospective, case-controlled, randomized pilot study, one axilla from six different subjects with axillary hyperhidrosis was treated with monthly laser hair reduction sessions using the 1064 nm Nd:YAG laser at typical settings. The contralateral axilla acted as a control. Subjects were asked to subjectively classify improvement of axillary sweating using a Global Assessment Questionnaire (GAQ) weekly after each treatment. Qualitative evaluation of sweating was also performed using a modified starch iodine test monthly after each treatment. In addition, prior to the first treatment and at one month following the final treatment, a punch biopsy was performed on the treatment axilla to assess for histologic changes to the eccrine gland and surrounding structures.
Results: Statistically significant improvements in subjective ratings of sweating using the GAQ compared to baseline were observed. Objective improvements in sweating with modified starch iodine testing comparing treated versus non-treated axillae were also seen for at least nine months in selected subjects. No significant differences in pre- and post-treatment biopsies were noted on routine histology.
Conclusions: Laser hair reduction using the 1064 nm Nd:YAG at laser hair removal settings provides subjective and objective improvements in patients with focal axillary hyperhidrosis.
J Drugs Dermatol. 2012;11(1):59-63.
A Randomized, Double-Blind, Controlled Comparative Trial of the Anti-Aging Properties of Non-Prescription Tri-Retinol 1.1% vs. Prescription Tretinoin 0.025%
Elizabeth T. Ho BS,a Nathan S. Trookman MD,b Brian R. Sperber MD PhD,b Ronald L. Rizer PhD,c Ralph Spindler PhD,d Sujatha Sonti PhD,a Vincent Gotz MS Pharm,e Rahul Mehta PhDa|Vitamin A and its derivatives (commonly termed retinoids) are widely used in topical anti-aging products. Certain retinoids such as retinol and its esters are available without a prescription, while others such as tretinoin are available only via prescription. A randomized, double-blind, controlled clinical study was conducted to compare the efficacy and tolerability of a tri-retinol 1.1% gradual release cream vs. tretinoin 0.025% cream in females with mild-to-moderate facial photodamage. Subjects applied the test product to the entire face in the evening after cleansing in a progressively increasing frequency starting twice weekly for the first week, followed by three times weekly during the second week and then daily as tolerated for the third week and beyond. Treatment was continued for a total of three months. Clinical evaluations and standardized digital photographs were performed at baseline and after four, eight, and 12 weeks of treatment. Self-assessment questionnaires were completed by the subjects at four, eight, and 12 weeks to assess perceived efficacy of the test products. Thirty-four subjects (16: tri-retinol and 18: tretinoin) completed the study. Both test products significantly improved signs of photodamage, including fine and coarse periocular wrinkles, skin firmness, skin tone, mottled pigmentation, tactile roughness, overall photodamage and global photodamage improvement. There were no significant differences in efficacy between the two products for these assessments. The adverse effects (which were graded as mild or less) were those typically seen with topical retinoids. Subjects reported >93 percent overall satisfaction with both products at weeks 8 and 12.
J Drugs Dermatol. 2012;11(1):64-69.
Comparison of the Effects of Contractubex® Gel in an Experimental Model of Scar Formation in Rats: An Immunohistochemical and Ultrastructural Study
Mustafa T. Sahin MD,a Sevinc Inan MD,b Serap Ozturkcan MD,a Elif Guzel MDc Cemal Bilac MD,a Gülsen Giray MD,b Sevda Muftuoglu MDd|
Background: Contractubex® gel, a commercial treatment for scars, consists of a mixture of onion extract (cepea extract), heparin sodium, and allantoin. It exerts a softening and smoothing effect on indurated, hypertrophic, painful, and cosmetically-disfiguring scar tissue.
Aim: To compare and discuss the immunohistochemical and ultrastructural effects of treatment of an experimental scar in a rat model with Contractubex gel.
Methods: Thirty-two Sprague-Dawley rats were divided into four groups. Skin biopsies were taken to develop full thickness wounds. After 10 days, Contractubex gel, heparin, and allantoin were topically applied daily to groups 2, 3, and 4, respectively. Group 1 was the control group. On the 30th day, scar tissues were excised to investigate the immunohistochemical and ultrastructural effects of these agents. For this purpose we used TGF-beta, laminin, and fibronectin primary antibodies.
Results: Increased immunoreactivities of laminin, fibronectin, and TGF-beta in control group, moderate immunoreactivities in heparin and allantoin groups, and mild immunoreactivities in the Contractubex gel group were observed. In semi-thin sections, Group 2 showed the thinnest epidermis of the four groups. In electron micrographs of Group 2, completely keratinized and normally appearing cells could be seen.
Conclusions: Immunohistochemical and ultrastructural observations demonstrated that the Contractubex gel significantly improved the quality of wound healing and reduction of scar formation. Also, it was a more appropriate treatment choice than heparin monotherapy and allantoin monotherapy in keloidal and hypertrophic scars.
J Drugs Dermatol. 2012;11(1):74-81.
Safety and Efficacy Evaluation of Tretinoin Cream 0.02% for the Reduction of Photodamage: A Pilot StudyBackground: Clinical studies as well as histologic data maintain that tretinoin improves the appearance of photodamage; however, the long-term benefits of tretinoin 0.02% in moderate to severe photodamage have not been established.
Objective: We performed independent assessments to demonstrate the long-term safety and efficacy of tretinoin emollient cream 0.02% for moderate to severe facial photodamage.
Methods: A single-center, open-label, single-group observational study followed 19 patients over 52 weeks. Efficacy assessments consisted of the Glogau Photodamage Classification Scale and severity grading of photodamage signs and symptoms. Facial photography and biopsies were taken from three subjects at baseline and final visits. Tolerability was assessed by the investigator.
Results: Twelve patients completed 52 weeks of treatment. Mean change in Glogau photodamage demonstrated statistically significant differences at 3, 6, 9, and 12 months (P<.0005). All patients with moderate to severe photodamage had improved to mild photodamage status by 9 months. Statistically significant improvements (P<.05) were observed at all time points for fine wrinkling, tactile roughness, and mottled hyperpigmentation as well as for lentigines at 6, 9, and 12 months and telangiectasia at 12 months. Biopsy samples revealed microscopic improvement in photodamage. Tretinoin cream 0.02% was generally well-tolerated, with few subjects experiencing adverse events.
Limitations: Our pilot study is limited by lack of control and the small study sample.
Conclusions: Tretinoin cream 0.02% was safe and effective for moderate to severe photodamage of facial skin and demonstrated sustainable benefits over an entire year based on the clinically validated Glogau classification system and expert visual grading analysis.
J Drugs Dermatol. 2012;11(1):83-90.
Tejaswi Mudigonda BS, Tushar S. Dabade MD, Steven R. Feldman MD PhD|
Background: 308 nm excimer laser phototherapy is efficacious in the treatment of localized psoriasis. Different approaches regarding dose fluency, number of treatments, and maintenance have been utilized, and there is yet to be a consensus on standard protocol.
Objective: To characterize treatment parameters for 308 nm excimer laser phototherapy.
Methods: We performed a PubMed search for studies describing excimer laser treatment protocol with particular attention to dosage determination, dose adjustment, dose fluency, number of treatments, and maintenance.
Results: Seven prospective studies were found describing the excimer efficacy for psoriasis. All studies determined the initial treatment dose using either the minimal erythema dose (MED) or induration. Fluency ranged from 0.5 MED (low) to 16 MED (high); one study demon- strated that medium to high fluencies yielded better improvement in fewer number of treatments. Fluency adjustments during the course of treatment were important to minimize phototherapy-associated side effects. The use of higher fluencies was reported to result in higher occurrences of blistering. One study implemented a maintenance tapering of dose-frequency phase to better manage psoriasis flare-ups.
Conclusion: The 308 nm excimer laser is an effective therapy for psoriasis regardless of the method used to determine initial dosage, dose fluency, or number of treatments. As its usage as a targeted monotherapy increases, future trials should consider evaluating and modifying these parameters to determine the most optimal management of localized psoriasis. Based on our reviewed studies, there is no consensus for a single excimer laser therapy protocol and as a result, patient preferences should continue to be an important consid- eration for phototherapy regimen planning.
J Drugs Dermatol. 2012;11(1):92-97.
Background: The bilobed and hatchet flaps are well-accepted reconstructive options for the correction of defects of the lower third of the nose. Optimal utilization of these flaps depends on understanding the characteristics of each flap as well as anatomic considerations related to the distal nasal area. Disregarding the limitations of either method may lead to flap failure and unacceptable aesthetic results.
Objective: We present three original ideas: 1) a bilobed flap may be considered as a hatchet flap with a Z-plasty; 2) the trap door deformity (TDD) associated with a bilobed flap can be used as an advantage; and 3) an easy method for preoperative planning of a bilobed flap.
Methods: We collected data from patients who underwent excision of basal cell carcinoma (BCC) of the distal third of the nose and reconstruction with a hatchet or a bilobed flap within the last 20 years.
Results: Favorable cosmetic results were achieved when a hatchet flap was used to reconstruct defects of the inferior third of the nasal side wall, above or bordered with the alar crease, and when a bilobed flap was used to reconstruct nasal tip para-medial defects above the lower lateral cartilage convexity.
Conclusions: We suggest choosing between the hatchet and bilobed flaps for nasal reconstruction according to the defect location as outlined by our findings.
J Drugs Dermatol. 2012;11(1):99-102.
Topical bimatoprost was FDA approved in December of 2008 for the treatment of eyelash hypotrichosis. Since its approval, some physicians have advocated the use of bimatoprost "off label" for hair growth in other areas, such as the scalp or eyebrows, but there has yet to be published scientific evidence to support this use. We report one of the first cases of significant eyebrow hair growth in a patient after use of topical bimatoprost for eyebrow hypotrichosis.
J Drugs Dermatol. 2012;11(1):106-108.
Elizabeth Lazaridou MD PhD, Christina Fotiadou MD, Christina Giannopoulou MD, Demetrios Ioannides MD PhD|
The painful, erythematous and eroded vulva often proves to be a diagnostic problem both clinically and histologically. Its differential diagnosis includes both non-neoplastic and neoplastic diseases like Bowen's disease and squamous cell carcinoma (SCC). We report the case of a 62-year-old woman diagnosed, after considerable delay, with Bowen's disease of the vulva that eventually progressed to invasive SCC, despite the treatment with imiquimod 5% cream. Our case indicates, on one hand, that dermoscopy could contribute to the accuracy of the pre-operative clinical diagnosis. On the other hand it confirms the fact that treatment of Bowen's disease of the vulva could be rather intriguing. Although imiquimod 5% cream is an effective, non-invasive treatment option for large lesions or poor healing sites, it should be administered with great consideration in carefully selected cases.
J Drugs Dermatol. 2012;11(1):110-112.
Transient Improvement in Chronic Psoriasis After Treatment of TNF-α Blocker Induced Disseminated M. Tuberculosis Infection
Philip R. Letada MD, Erin Hitchcock DO, Samuel L. Steele MD, Douglas Winstanley DO|Improvement in psoriasis after treatment of reactivated latent tuberculosis following initiation of TNF-α inhibitor therapy has yet to be described in the literature. The authors present a case of transient, yet significant, improvement in chronic plaque psoriasis after antibiotic therapy for reactivated TB.
J Drugs Dermatol. 2012;11(1):119-120.
In the US, soft tissue fillers are currently administered using sharp, hypodermic needles. The choice in length and gauge of needle is determined by the injector's preferences, as well as the physical properties of the filler itself. While some adverse events are injector-dependent, others may be due to risks inherent to using sharp needles. The use of new, flexible cannulas with blunt tips may potentially both lower these risks and change the techniques by which fillers are administered in the future.
J Drugs Dermatol. 2012;11(1):70-72.
Ali Alikhan MD and Alison J. Bruce MBBS|Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the Mayo Clinic Dermatology Residency Training Program. The editor of Resident Rounds is Omar A. Ibrahimi MD PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at OIbrahimi@jddonline.com.
No abstract details for the moment.
No abstract details for the moment.
Kendra Gail Bergstrom MD|Atopic dermatitis is increasing in prevalence throughout the developed world, in parallel with asthma and hay fever. The reasons for the increase remain unclear. As a practical question, it is valuable to understand which interventions might decrease risk for childhood atopic disease. Prospective studies among infants and children are challenging to design and to execute. Fortunately, several large studies from Europe and the United States are better characterizing whether behavioral interventions such as breastfeeding, delayed introduction of solid foods, hydrolyzed protein infant formulas, or pets in the home might be protective or impart increased risk of developing atopic dermatitis. As this body of literature grows, physicians will be able to recommend behavioral interventions that can prevent atopic dermatitis in individuals and ideally decrease prevalence over the population.
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
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.
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|Emervel: Full-Face Rejuvenation With a Range of Customized Hyaluronic Acid Fillers This supplement to the Journal of Drugs in Dermatology discusses a new range of hyaluronic acid fillers suited for various indications. The authors highlight the key physical properties of this new range of fillers and present results of a multi-center, comprehensive trial in which up to eight indications could be treated simultaneously (including nasolabial folds, marionette lines, periorbital lines, upper lip lines, cheek folds, tear-troughs, lips and cheeks) using this filler range.