Claudia Hossain BS,a Dennis A. Porto MD,b Iltefat Hamzavi MD,b and Henry W. Lim MDb
Vitiligo is an acquired condition resulting in patches of depigmented skin that is cosmetically disfiguring and can subsequently be psychologically disturbing. For patients seeking to mask their vitiligo, camouflage options have historically been limited and been designated
as a cosmetic, rather than a medical, concern. As research has indicated that proper concealment of vitiligo lesions can vastly improve quality of life, we believe it is essential that dermatologists become aware of all the options available to their patients and that discussions of camouflage options be broached from the first visit. Methods for concealment include cosmetic tattoos, dihydroxyacetone,
general cosmetics, and various topical camouflage agents, including the newest product, Microskin™. We conducted a literature review of all of the available options for vitiligo concealment and evaluated their advantages and disadvantages. Ultimately, temporary methods of concealment are recommended; but the particular agent used can come from discussion with the patient based on the location of the lesions, degree of concealment desired, cost, and availability.
J Drugs Dermatol. 2016;15(4):384-387.
Kurt Jarnagin PhD,a Sanjay Chanda PhD,b Dina Coronado BS,a Vic Ciaravino PhD,a Lee T. Zane MD,a Emma Guttman-Yassky MD PhD,b and Mark G. Lebwohl MDb
Crisaborole topical ointment, 2% (formerly known as AN2728) is a benzoxaborole, nonsteroidal, topical, anti-inflammatory phosphodiesterase 4 (PDE4) inhibitor investigational compound that recently completed phase 3 studies for the treatment of mild to moderate atopic dermatitis (AD). The unique configuration of boron within the crisaborole molecule enables selective targeting and inhibition of PDE4, an enzyme that converts the intracellular second messenger 3’5’-cyclic adenosine monophosphate (cAMP) into the active metabolite adenosine monophosphate (AMP). By inhibiting PDE4 and thus increasing levels of cAMP, crisaborole controls inflammation. The use of boron chemistry enabled synthesis of a low–molecular-weight compound (251 daltons), thereby facilitating effective penetration of crisaborole through human skin. In vitro experiments showed that crisaborole inhibits cytokine production from peripheral blood mononuclear cells in a pattern similar to other PDE4 inhibitors and distinct from corticosteroids. Crisaborole also displayed topical anti-inflammatory activity in a skin inflammation model. Once crisaborole reaches systemic circulation
after topical application, it is metabolized to inactive metabolites. This limits systemic exposure to crisaborole and systemic PDE4 inhibition. In phase 1 and 2 clinical studies, crisaborole ointment, 2% was generally well tolerated and improved AD disease severity scores, pruritus, and all other AD signs and symptoms. Two large, randomized, controlled, phase 3, pivotal clinical trials assessing
the efficacy and safety of crisaborole topical ointment, 2% in children, adolescents, and adults with mild to moderate AD were recently completed with positive results.
J Drugs Dermatol. 2016;15(4):390-396.
Amy McMichael MD,a Hanh Pham MA,b Erika von Grote PhD,c and Matthew H. Meckfessel PhDc
Female pattern hair loss (FPHL), also known as female androgenic alopecia, affects over 21 million women in the United States with devastating effects on self-esteem and psychosocial functioning. Topical minoxidil 2% and 5% formulations are the only US Food and Drug Administration-approved treatments for FPHL. The length of time it typically takes to observe the benefits is a challenge for many patients, and may affect adherence to treatment. Herbal extracts, which are also believed to promote healthier-looking hair, have a long history of use in hair care formulations. The safety and efficacy of a twice-daily regimen of 2% minoxidil solution used in combination with the botanical hair solution for 12 weeks in 54 subjects was evaluated in a multicenter, single-arm, open-label study. Assessments included investigator and subject ratings of improvement and subject satisfaction. Investigator ratings indicated significant improvement
in hair growth and overall treatment benefits in as early as 6 weeks (P<.001). Subject self-ratings indicated significant satisfaction with hair volume and quality improvement at week 6 (P<.001). Subjects also indicated an increase in self-confidence and attractiveness
at week 12 (P<.001). The investigator and subject-assessed efficacy and subject satisfaction with this regimen provides clinicians with an effective treatment option for FPHL that also provides a high level of patient acceptance, which ultimately may help promote minoxidil treatment adherence.
J Drugs Dermatol. 2016;15(4):398-404.
Terrence C. Keaney MD,a Hanh Pham MA,b Erika von Grote PhD,b and Matthew H. Meckfessel PhDc
Androgenic alopecia (AGA) is the most common type of hair loss in men, characterized by hair miniaturization, hairline recession, and vertex balding. It affects approximately 50% of men, negatively affecting self-esteem and sociability. Topical minoxidil formulations are approved up to a 5% concentration for men, but patient adherence to treatment is challenged by gradual results that may be perceived as a lack of initial benefit. Herbal extracts, which are also believed to promote healthier-looking hair, have a long history of use in hair care formulations. The safety and efficacy of a twice-daily regimen of 5% minoxidil foam used in combination with a novel botanical hair solution was evaluated in a 12-week, multicenter, single-arm, open label study in 56 subjects with mild to moderate AGA. Assessments
included investigator ratings of improvement and subject self-ratings of satisfaction. Investigator ratings indicated significant improvement in scalp hair coverage and perception of overall treatment benefit in as early as 4 weeks (P<.001). Subject self-ratings were significant for improved hair growth and hair appearance in as few as 4 weeks (P<.05). The regimen was well tolerated, and subjects indicated a high degree of satisfaction. Investigator and subject-assessed efficacy and subject satisfaction with this novel regimen provide clinicians with an effective treatment option for AGA that also provides a high level of patient satisfaction, which may help promote patient adherence to long-term treatment.
J Drugs Dermatol. 2016;15(4):406-412.
Lauren R. Seale BS,a Ariana N. Eglini BA,b and Amy J. McMichael MDc
5 α-reductase inhibitors such as finasteride and dutasteride have been studied for the treatment of hair loss in men, with finasteride being the only Food and Drug Administration-approved treatment. Increasingly, in recent years, off-label use of these drugs has been employed in the treatment of female pattern hair loss (FPHL) and frontal fibrosing alopecia (FFA) in women. Side effects with 5 α-reductase inhibitors can include changes in sexual function, and recent publications have characterized an increasing prevalence of these in men. A review of 20 peer-reviewed articles found that very few side effects, or adverse events, related to sexual function
have been reported in studies in which dutasteride or finasteride has been used to treat hair loss in women. Future publications should investigate not only the efficacy of these drugs in treating FPHL and FFA, but the side effect profile in patients as well.
J Drugs Dermatol. 2016;15(4):414-419.
E. Victor Ross MD,a Travis W. Blalock MD,a Douglas Winstanley DO,a Joel L. Cohen MD,b and James J. Childs PhDc
A melanin meter has been created to assess real time skin pigmentation to optimize settings for visible light aesthetic applications.
METHODS: A handheld meter was applied to non sun-damaged skin on the back of volunteers to measure skin pigmentation prior to treatment with IPL light sources over a range of pulse widths and ascending fluences. Curves for maximum epidermal tolerances as a function of pigmentation were determined. These curves were then tabulated for each pulse width in device software to provide guidance in the selection of fluences. Based on these findings, the device was applied in over 300 patients at a comprehensive laser and cosmetic dermatology center.
RESULTS: A pigment meter evaluation led to treatment parameter guidance in intense pulsed light applications. These suggested ranges for settings based on the melanin index score proved useful, accurate, and safe in applications over a broad range of skin colors and across various anatomic units of the skin.
CONCLUSION: A pigment meter can be used to identify appropriate settings with IPL treatments in order to enhance safety and efficacy when treating epidermal pigmented lesions, vessels, general photodamage and excessive hair (where the principles of selective photothermolysis
J Drugs Dermatol. 2016;15(4):421-432.
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
BACKGROUND: Hyaluronic acid (HA) is a popular ingredient in topical formulations for cosmetic improvement of the skin. Most formulations
contain linear, non-crosslinked HA oligomers, low molecular weight (LMW) HA, and/or high molecular weight (HMW) HA. Crosslinking
of HA enhances its clinical longevity and mechanical characteristics. The objective of this study was to characterize the topical effects of a new, crosslinked resilient HA (RHA) that is also available as a cohesive, tissue-integrating injectable filler, compared with non-crosslinked HMW HA and LMW HA. Living human skin explants that preserve the 3-dimensional structure of in vivo skin were used to maximize clinical relevance.
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.
Douglas E. Kligman MD PhDa and Zoe D. Draelos MDb
BACKGROUND: Salicylic acid (SA) and retinoids, tretinoin (all-trans retinoic acid [ATRA]), and retinol (all-trans retinol) are widely used as topical agents for the improvement of photodamage and acne vulgaris. They can be used in daily take-home products or as part of an in-office procedure, combining the benefits of a keratolytic (SA) and a retinoid.
OBJECTIVE: The objective of this research was to compare the efficacy for ameliorating photodamage of topical tretinoin (0.25%) and retinol (0.25%) to baseline and with each other when applied after a 30% salicylic acid peel on human facial skin.
METHODS: Twenty female subjects received a full face 30% SA peel followed by the overnight application of tretinoin to a 1 randomized half-face and retinol to the opposite side (split-face study). The identical procedure was repeated at week 2. Double-blinded subject and investigator assessments of the results were captured at weeks 2 and 4.
RESULTS: By investigator evaluation, both peeling regimens were effective in improving photodamage parameters compared to baseline. (ATRA P-values at week 4 were: P=.00008 texture, P=.00013 roughness, P=.00221 pores, P=.00098 dryness, P=.02770 erythema, and P=.00008 overall appearance. Retinol P-values at week 4 were: P=.00019 texture, P=.00053 roughness,
P=.00221 pores, P=.00147 dryness, P=.02770 erythema, and P=.0043 overall appearance.) By subject self-assessment compared with baseline, both tretinoin and retinol were effective in improving overall appearance (ATRA P=.0229 and retinol P=.0190). By investigator evaluation comparing tretinoin with retinol, tretinoin was slightly better than retinol at week 4 in improving texture P=.00506, roughness P=.01171, and overall appearance P=.00506. By subject self-assessment comparing tretinoin with retinol, there was no difference in overall appearance (ATRA P=.2367 and retinol P=.3613).
CONCLUSION: Either topical tretinoin (0.25%) or retinol (0.25%) can be used safely and effectively when applied in office immediately after SA peeling to ameliorate signs of photoaging.
J Drugs Dermatol. 2016;15(4):442-450.
Emily C. Milam BA and Evan A. Rieder MD
The cosmeceutical industry is a multi-billion dollar, consumer-driven market. Products promise highly desirable anti-aging benefits, but are not subject to regulation. We present an introduction to cosmeceuticals for the general and cosmetic dermatologist, including definitions
and explanations of key terms, an approach to the evidence base, a dissection of chamomile and green tea, two paradigmatic cosmeceutical products, and a window into the underlying psychology of this vast marketplace.
J Drugs Dermatol. 2016;15(4):452-456.
This randomized, controlled, investigator-blinded study performed by an independent research organization evaluated the appearance of periorbital and perioral wrinkles following twice-daily application of a specific blend of matrikines and matrikine-like synthetic peptides
for skin rejuvenation over a 6-month period. Fine lines and wrinkles of 133 women, aged 38 years to 65 years, were assessed by an independent expert evaluator using a 5-point visual analogue score. Subjects were divided into 3 groups and randomized to receive either the matrikine-based technology (MPC) or 1 of the 2 materials containing traditional growth factors. Test materials were well tolerated, and all 3 significantly reduced the appearance of periorbital and perioral wrinkles after 3 and 6 months. In the group receiving
the matrikine-based technology, periorbital wrinkles improved (≥ 1 unit) in 28% of subjects after 1 month, in 65% after 3 months, and in 81% after 6 months. Perioral wrinkles improved (≥ 1 unit) in 39% of subjects after 1 month, in 41% after 3 months, and in 59% after 6 months. Improvements in skin firmness, tactile roughness, and pore appearance were also observed with each test material. Use of MPC was associated with significantly improved skin elasticity after 2 months (20%) and at 6 months (16%), whereas the comparator materials had no significant effects on elasticity. This study demonstrates that topical use of a specific blend of matrikines and matrikine-like peptides is suitable for skin rejuvenation. It also provides evidence that topical use of this novel technology provides comparable results to other technologies that use traditional growth factors for skin rejuvenation, with an additional potential benefit of improved skin elasticity.
J Drugs Dermatol. 2016;15(4):457-464.
Marta Rendon MD FAADa and Laurence Dryer PhDb
OBJECTIVE: To evaluate the treatment of mild-to-moderate epidermal melasma and photodamage using a 4% hydroquinone skin care system plus tretinoin 0.02% cream.
METHODS: Single-center, investigator-blinded study in 39 adult females with mild-to-moderate epidermal melasma, mild-to-marked pigmentation
intensity, and Fitzpatrick skin type III to VI treated for 24 weeks. Improvements in melasma severity, pigmentation intensity, photodamage, and patient satisfaction were assessed at weeks 4, 8, 12, 18, and 24. Cutaneous tolerability was assessed by investigator
(erythema, dryness, peeling) and patients (burning and stinging). Adverse events (AEs) were monitored throughout.
RESULTS: Melasma severity, pigmentation intensity, and melasma area and severity index (MASI) scores relative to baseline were all significantly reduced from week 4 onward (P<.001). In addition, signs of facial photodamage were significantly improved. At week 24, 87.9% of patients were “satisfied” or “very satisfied” with the overall treatment effectiveness and Quality of Life (QoL) was much improved. No patient discontinued due to lack of efficacy or treatment-related AEs. One patient (2.8%) reported severe cutaneous intolerability (erythema at week 4).
CONCLUSION: Treating mild-to-moderate melasma using a 4% hydroquinone skin care system plus 0.02% tretinoin cream can significantly
reduce the severity and intensity of melasma and associated pigmentation, and improve signs of photodamage within four weeks. Treatment was generally well tolerated and associated with high levels of patient satisfaction.
J Drugs Dermatol. 2016;15(4):466-475.
James H. Herndon Jr. MD,a Lily I. Jiang PhD,a Tatiana Kononov BS MBA,b and Theresa Fox BSb
A 12-week open-label, single-center clinical usage trial was conducted to determine the effectiveness of a dual product regimen
consisting of a 0.5% retinol treatment and an anti-aging moisturizer with 30% vitamin C in women with mild to moderate hyperpigmented and photodamaged facial skin. Clinical grading of several efficacy parameters, tolerability evaluations, subject self-assessment questionnaires, and digital photography were completed at baseline and at weeks 4, 8, and 12. A total of 44 women completed the study. Effective ingredients incorporated into the 0.5% retinol treatment included encapsulated retinol for a retinol concentration of 0.5%, bakuchiol, and Ophiopogon japonicus root extract. The anti-aging moisturizer with 30% vitamin C contained 30% vitamin C in the form of tetrahexyldecyl ascorbate (THD ascorbate), alpha-tocopheryl acetate (vitamin E) and ubiquinone
(coenzyme Q10). The facial regimen produced a statistically significant decrease (improvement) in clinical grading scores for all parameters assessed at weeks 8 and 12 when compared with baseline scores. In addition, the majority of these parameters were improved at week 4. The test regimen was well-perceived by the subjects for various inquiries regarding facial skin condition, product efficacy, and product attributes. Several tolerability parameters were assessed with no statistically significant increase except for dryness. A statistically significant increase in clinical grading scores for dryness on the face occurred at weeks 4 and 8 when compared to baseline scores. The increase in dryness is expected when introducing a retinol product to a facial regimen and the dryness did not persist to the week 12 time point.
J Drugs Dermatol. 2016;15(4):476-482.
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
Although manufacturers’ instructions for use of dermal fillers ordinarily direct injection in the superficial, mid or deep dermis, or, in some cases, the hypodermis (subcutis), the precise depth of injection may not always be for injectors. In this article, investigators report findings gathered from histopathology, ultrasound, “live” one on one training injections, as well as application of a mathematical formula for depth calculation of the various layers within the dermis. Areas of particular interest are the superficial reticular dermis and the mid dermis. Following the depth measurements detailed by Della Volpe et al in 2012, investigators compare and contrast their own depth findings of the various layers, arriving at the conclusion that the depth of the dermis is not as deep as had been previously assumed.
The investigators also develop an argument for the appropriate angles of injection for placement of dermal filler into the various layers, demonstrating that the heretofore widely used angles of 30˚ and 45˚ are far more acute than required.
J Drugs Dermatol. 2016;15(4):483-490.
Jeanine Downie MDa and Miroslav Kaspar MDb
BACKGROUND: Noninvasive body shaping methods seem to be an ascending part of the aesthetics market. As a result, the pressure to develop reliable methods for the collection and presentation of their results has also increased. The most used techniques currently include ultrasound measurements of fat thickness in the treated area, caliper measurements, bioimpedance-based scale measurements
or circumferential tape measurements. Although these are the most used techniques, almost all of them have some limitations in reproducibility and/or accuracy. This study shows Magnetic Resonance Imaging (MRI) as the new method for the presentation of results in the body shaping industry.
MATERIALS AND METHODS: Six subjects were treated by a contactless selective radiofrequency device (BTL Vanquish ME, BTL Industries Inc., Boston, MA). The MRI fat thickness was measured at the baseline and at 4-weeks following the treatment. In addition to MRI images and measurements, digital photographs and anthropometric evaluations such as weight, abdominal circumference, and caliper fat thickness measurements were recorded. Abdominal fat thickness measurements from the MRI were performed from the same slices determined by the same tissue artefacts.
RESULTS: The MRI fat thickness difference between the baseline measurement and follow up visit showed an average reduction of 5.36 mm as calculated from the data of 5 subjects. One subject dropped out of study due to non-study related issues. The results were statistically significant based on the Student’s T-test evaluation.
CONCLUSIONS: Magnetic resonance imaging abdominal fat thickness measurements seems to be the best method for the evaluation of fat thickness reduction after non-invasive body shaping treatments. In this study, this method shows average fat thickness reduction of 5.36 mm while the weight of the subjects didn’t change significantly. A large spot size measuring 1317cm2 (204 square inches) covers the abdomen flank to flank. The average thickness of 5.36 mm of the fat layer reduced under the applicator translates into significant cumulative circumferential reduction. The reduction was not related with dieting.
J Drugs Dermatol. 2016;15(4):491-495.
Joel Schlessinger MD,a Subhash Saxena PhD,b and Stuart Mohrb
There are few creams that have been developed for the purpose of treating the aging hand, yet UV damage and secondary signs of aging on the hands make them one of the most obvious indicators of age outside the face. This study documents results of a 120 day trial using a novel cream preparation containing ingredients including Retinol, Alpha-Arbutin, Kojic Dipalmitate, Azaeleic Acid, Hexylresorcinol,
Licorice Root, and other ingredients. Results were tabulated comparing physician and patient assessment scores using a comprehensive
scoring assay, which showed significant improvements across eight parameters tested. This was statistically significant for physician ratings of texture, wrinkles and pigment at 120 days versus baseline (P <0.001). Further research is needed, but the results appear to indicate the benefits of a targeted hand cream in improving the appearance of the aging hand.
J Drugs Dermatol. 2016;15(4):496-503.