A Multi-center Trial Evaluating a Serum Comprised of Plant-based Adaptogens Targeting Skin Quality.

Objective: The ability of the skin to maintain homeostasis declines with age. Adaptogens support the capacity of the skin to respond to stress. We sought to evaluate the efficacy of a novel serum comprised of plant-based adaptogens for improving photoaged skin following twice-daily application. Methods: A multi-center, 12-week trial was conducted in participants aged 45 to 65 years, Fitzpatrick Skin Type (FST) I to VI, with mild-to-severe photoaging based on a 10-point grading scale (3 [Minimum] to 7 [Maximum]). Visible improvements were assessed in erythema, pore size, skin dullness, skin texture, and uneven pigmentation utilizing a six-point grading scale (0=None to 5=Severe). Global skin quality was measured utilizing our Global Skin Quality Index (GSQI). Sebum measurements were obtained in a subset of participants. Patient satisfaction and tolerability were recorded throughout the study. Results: Fifty-three participants were enrolled and completed the study. Mean age was 56 years and 66 percent were White, 17 percent were Black, 8 percent were Hispanic, 6 percent were Asian/Pacific Islander, and 81 percent had moderate photodamage. At Week 12, significant mean percent improvements from baseline were demonstrated in erythema (50%), dullness (44%), texture (52%), pore size (23%), and uneven pigmentation (21%; all p<.0001). Significant GSQI improvements from baseline were observed at Week 12 (39%; p<0.0001). Significant mean reductions from baseline in skin surface sebum were demonstrated at Week 12 (-38%; p<0.0001). All adverse events (AEs) were mild and transient. Conclusion: A novel serum comprised of plant-based adaptogens, demonstrated improvements from baseline in the appearance of erythema, dullness, texture, pore size, uneven pigmentation, and global skin quality over 12 weeks. Participants reported high levels of satisfaction, with mild, transient AEs reported.

Gene Expression Analysis of a Topical Serum Comprised of Plant-based Adaptogens Developed to Support Homeostasis and Skin Quality.

Objective: A topical serum comprised of plant-based adaptogens was purposefully developed to support the ability of the skin to adapt and achieve balance. The study described herein evaluated changes in the expression of target genes related to skin homeostasis following topical exposure. Methods: Utilizing an in vitro epidermal skin model, quantitative polymerase chain reaction (qPCR) analysis of gene expression was conducted following 48-hour exposure to 15µL of the study product (MYS serum) to the surface of each tissue (N=4). Biomarkers that play a key role in skin homeostasis were analyzed: Aryl hydrocarbon receptor (AhR), chloride channel accessory 2 (CLCA2), metallothionein 1A (MT1A), 1F (MT1F), and 1G (MT1G), and thioredoxin reductase 1 (TXNRD1). Statistically significant changes were calculated using unpaired t-test analysis (p<0.05) versus control (saline). A linear Fold Change (FC) value >2 was considered statistically significant. Results: An 85 percent (FC=1.85) increase in expression of AhR vs. control occurred following exposure to MYS serum indicating enhanced support of cellular and epidermal homeostasis, and the skin barrier's response to stress. Statistically significant increases in expression occurred with TXNRD1 (293%; FC=3.93), MT1A (307%; FC=4.07), MT1F (529%; FC=6.29), and MT1G (163%; FC=12.63) vs. control, indicating support of skin's adaptive response to stress and immune homeostasis. Significantly decreased levels of CLCA2 were demonstrated (69%; FC=-3.24) indicating inhibition of oxidative stress-induced senescence. Conclusion: Utilizing an in vitro epidermal skin model, a serum comprised of plant-based adaptogens demonstrated changes in the expression of target genes that play important roles in skin's ability to respond to stress and achieve homeostasis.

Evaluation of an advanced antioxidant and double-conjugated retinoid/AHA cream in participants with FST IV-V.

BACKGROUND: Topical antioxidants and retinoids are foundational components of an effective skincare regimen. Pyrroloquinoline quinone (PQQ) is a potent free radical scavenger that supports efficient mitochondrial energy creation. An advanced antioxidant combines topical allyl PQQ with existing WEL antioxidant technology (TAP) to comprehensively address extrinsic and intrinsic skin aging. In conjunction with TAP, a double-conjugated retinoid/alpha hydroxy acid (AHA-Ret) designed to minimize irritation and optimize delivery was used over 12 weeks to improve the appearance of photodamaged skin. PATIENTS/METHODS: Twice-daily application of TAP and nightly application of AHA-Ret was evaluated in female participants aged 40-65 years with FST IV-V and mild (3) to moderate (6) facial photodamage using a 10-point grading scale. Visible improvements from baseline in lines/wrinkles, skin texture, skin tone, skin dullness and erythema were assessed using a six-point grading scale (0 = None to 5 = Severe). Adverse Events (AEs) were captured throughout the study period. RESULTS: Participants (N = 21; mean age, 56 years) equally represented mild and moderate photodamage, and FST IV and V (41%, Hispanic; 36%, African American; and 32%, Caucasian). Significant mean improvements from baseline occurred in skin dullness, skin texture, and skin tone (all, p < 0.0001), and significant mean reductions from baseline were demonstrated in erythema and melanin at Week 12. Mild, transient AEs were reported. No participant discontinued study participation due to an AE. CONCLUSIONS: A skincare regimen comprised of an advanced antioxidant and AHA-Ret cream, in conjunction with daily use of a broad-spectrum sunscreen (SPF 56), led to significant improvements at 12 weeks in the appearance of photodamaged skin in females with FST IV and V.

Cysteamine Isobionic-Amide Complex Versus Kligman's Formula for the Treatment of Melasma: Equal Efficacy and Rapid Onset of Action.

BACKGROUND: Modified Kligman's formula (mKF) is the gold standard treatment for melasma; however, its prolonged use is not recommended due to side effects. Cysteamine is a potent, safe, and effective depigmenting agent. Here, we conducted a double-blind, randomized, and placebo-controlled clinical trial to assess the efficacy of cysteamine isobionic-amide -- a complex with enhanced depigmenting efficacy -- and compared it to mKF for the treatment of melasma. METHODS: This study involved a total of 80 patients divided into 3 groups: cysteamine-isobionic amide, placebo, or mKF. The modified Melasma Area Severity Index (mMASI) score and spectrophotometric evaluation were conducted at baseline, week 4, week 8, and week 16. Dermatological assessment, patients’ feedback, and satisfaction including quality-of-life scores were also collected. RESULTS: At week 4, cysteamine isobionic-amide and mKF groups showed an equivalent onset of action in terms of mMASI and skin pigmentation contrast reduction. The 2 groups significantly reduced melasma severity and improved the overall skin condition with a comparable efficacy at week 16. Quality of life of melasma patients was significantly improved in the cysteamine isobionic-amide group at week 8 and further at week 16 (P<0.001) compared to the mKF group. Patients’ feedback and satisfaction were higher with the cysteamine isobionic-amide product compared to mKF. CONCLUSION: Cysteamine isobionic-amide provided a rapid onset of action and was as effective as the mKF for the treatment of melasma. The data suggest that cysteamine isobionic-amide could potentially be an acceptable alternative to mKF for the long-term treatment of melasma. J Drugs Dermatol. 2024;23(2):9-16.  doi:10.36849/JDD.7428.

Best practices in the treatment of melasma with a focus on patients with skin of color.

BACKGROUND: Melasma is a chronic hypermelanosis of the skin that affects approximately 1% of the global population, predominantly affects women, and is more prevalent in skin of color. Melasma is a common driver for patients with skin of color to seek out a dermatologist for treatment, and ensuring the right approach for these patients is important because some treatments may be associated with adverse side effects. Because of the chronicity of the disease and established psychosocial and emotional impacts, there is a large need to ensure care follows the best available evidence on the treatment of patients with melasma. OBJECTIVE: Here, we summarized current available topical treatments for melasma with considerations dermatologists should have for their patients with skin of color. METHODS: Steering committee consensus on clinical best practices. RESULTS: We describe a flexible and focused treatment algorithm that reflects both treatment and maintenance periods that is a consensus of our extensive clinical experience. LIMITATIONS: Use of real-world evidence and potential for individual practice bias. CONCLUSION: Melasma can be challenging to treat, particularly in patients with skin of color, and our recommendations for best practices for patients in the United States are an important step toward standardizing care.

Dermatology's role in the fight against human trafficking: A report from the AAD Ad Hoc Task Force and call to action.

While the majority of American Academy of Dermatology members have some broad awareness of human trafficking, most are not aware of it in their communities or of the skin signs that could prompt identification of those being exploited, and have requested educational resources to assist patients affected by trafficking. The American Academy of Dermatology Ad Hoc Task Force on Dermatologic Resources for the Intervention and Prevention of Human Trafficking has been working to develop relevant resources, including an online toolkit on the American Academy of Dermatology website: https://www.aad.org/member/clinical-quality/clinical-care/human-trafficking.

Decades of beauty: Achieving aesthetic goals throughout the lifespan.

BACKGROUND: Several elements, including age, influence judgments of beauty and attractiveness. Aging is affected by intrinsic factors (e.g., genetics, race/ethnicity, anatomical variations) and extrinsic factors (e.g., lifestyle, environment). AIMS: To provide a general overview of minimally invasive injectable procedures for facial beautification and rejuvenation to meet the aesthetic goals of patients across their lifespan, organized by decade. METHODS: This case study review describes aesthetic considerations of females in their third to sixth decade of life (i.e., 20-60 years of age or beyond). Each case study reports the treatments, specifically botulinum toxin type A and soft tissue fillers, used to address aesthetic concerns. RESULTS: Signs of aging, as well as aesthetic goals and motivations, vary by age groups, cultures, and races/ethnicities. However, there are overarching themes that are associated with each decade of life, such as changes in overall facial shape and specific facial regions, which can be used as a starting point for aesthetic treatment planning. Appropriate patient selection, thorough aesthetic evaluation, product knowledge, and injection technique, as well as good physician-patient communication, are essential for optimal treatment outcomes. CONCLUSIONS: Nonsurgical facial injectable treatments can successfully enhance and rejuvenate facial features across different age ranges. A comprehensive understanding of facial aging and the aesthetic considerations of patients by the decade contributes to optimal treatment planning and maintenance.

PrabotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines in Adult Patients With Skin of Color: Post Hoc Analyses of the US Phase III Clinical Study Data.

BACKGROUND: Limited US clinical data are available on the use of aesthetic products in patients with skin of color (SOC). OBJECTIVE: To compare the efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines in patients with and without SOC. METHODS AND MATERIALS: Post hoc analyses were performed on the pooled population of all 492 patients treated with 20U prabotulinumtoxinA in the 2 US single-dose Phase III glabellar line clinical studies. Patients were grouped by Fitzpatrick skin Type: IV + V + VI (with SOC) versus I + II + III (without SOC). The primary efficacy end point was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. Adverse events (AEs) were also summarized. RESULTS: Responder rates among patients with SOC (n = 140) were lower than those without SOC (n = 352), by 5.9% on average across all visits; at no time point were differences statistically significant. At Day 30, responder rates were 94.0% and 96.0%, respectively (p = .401). Headache was the most common treatment-related AE, occurring in 12.1% and 8.2% of patients with and without SOC, respectively. CONCLUSION: A single dose of 20U prabotulinumtoxinA was well tolerated and similar in effectiveness in patients with and without SOC for the treatment of glabellar lines.

A case of hyperpigmentation induced by hydroxychloroquine and quinacrine in a patient with systemic lupus erythematosus and review of the literature.

Hydroxychloroquine (HQ) and quinacrine are widely used antimalarials for systemic lupus erythematosus (SLE) and other autoimmune diseases. We report a case of antimalarial-induced hyperpigmentation in a 57-year old African-American woman. The patient had a long-standing history of SLE that was treated with HQ and quinacrine in varying doses for 16 years. The disease improved considerably and entered remission; however, the patient subsequently developed severe, disseminated hyperpigmentation on her face, trunk, upper and lower extremities. A malar facial biopsy revealed numerous perivascular and scattered interstitial, heavily pigment laden dark brown to black macrophages. The Fontana Masson staining was positive for melanin, and Perl's stain for iron was negative. This staining pattern, to our knowledge, has only been reported once before in the literature. Our patient represents a rare case of severe recalcitrant hyperpigmentation induced by combination HQ and quinacrine therapy for SLE.

Impact of Iron-Oxide Containing Formulations Against Visible Light-Induced Skin Pigmentation in Skin of Color Individuals.

Visible light (400-700nm), which contributes to 45% of solar radiation, contributes to skin darkening and worsening of dyschromias, particularly in individuals with Fitzpatrick skin phototypes III and higher. Currently, sunscreens provide limited protection against that spectrum. Due to their capabilities in absorbing, scattering, and reflecting visible light, topical products containing pigments and/or metal oxides can provide additional photoprotection. In this study, the efficacy of two formulations containing iron oxide was evaluated in preventing visible light-induced pigmentation compared with a non-tinted mineral SPF 50+ sunscreen. Expert grading and colorimetry demonstrated that the iron-oxide containing formulations significantly protected against visible light-induced pigmentation compared to untreated skin or mineral SPF 50+ sunscreen in Fitzpatrick IV individuals. These results highlight that iron-oxide containing formulas in a foundation format have dual functions and can provide additional benefits in patients' daily routine by masking existing pigmentation and preventing the development of pigmentation triggered by sunlight exposure, extending protection beyond UV spectrum. J Drugs Dermatol. 2020;19(7): doi:10.36849/JDD.2020.5032 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Safety and Effectiveness of VYC-17.5L for Long-Term Correction of Nasolabial Folds.

BACKGROUND: Juvéderm Vollure XC (VYC-17.5L; Allergan plc, Dublin, Ireland) belongs to a family of hyaluronic acid gels based on the Vycross technology platform. OBJECTIVES: The authors sought to evaluate the safety and effectiveness of Vollure for correction of moderate to severe nasolabial folds (NLFs) over 18 months and after repeat treatment. METHODS: In this prospective, randomized study, patients (N = 123) received initial/touch-up treatment with Vollure in 1 NLF and control filler in the contralateral NLF. Patients received optional repeat treatment with Vollure after month 12, 15, or 18. Assessments included investigator-rated NLF Severity Scale responder rates (≥1-point improvement vs baseline), patient-assessed Appraisal of Nasolabial Folds scale of the FACE-Q questionnaire, and patient satisfaction (11-point scale). RESULTS: Median volume of Vollure injected was 1.7 mL for initial/touch-up treatment combined and 0.6 mL for repeat treatment. The NLF Severity Scale responder rates were 93%, 85%, and 59% at months 6, 9, and 18 after initial/touch-up treatment and increased to 94% at 1 month after repeat treatment. Mean patient-reported FACE-Q scores significantly improved from baseline at all timepoints. Most patients were very satisfied with treatment at all timepoints from day 3 (75%) through month 18 (68%) and at 1 month after repeat treatment (94%). Common injection site responses after initial/touch-up and repeat treatment were firmness, swelling, and tenderness to touch; most were mild/moderate. CONCLUSIONS: Vollure was safe and effective for correction of moderate to severe NLFs, with results lasting 18 months in 59% of NLFs. Repeat treatment required one-third of the injection volume to achieve similar improvement in NLF severity as initial/touch-up treatment.

In Vitro and In Vivo Efficacy and Tolerability of a Non-Hydroquinone, Multi-Action Skin Tone Correcting Cream

Background: Pigmentation disorders are therapeutically challenging to treat, requiring complicated regimens. Objectives: Alternatives to hydroquinone (HQ) are desired. We evaluated the efficacy and tolerability of a non-HQ multi-action skin tone corrector (ETCS) developed to inhibit melanin production and improve skin quality. Design and Methods: Twice-daily use of ETCS and ETCS + AHA-Ret, a retinoid-based alpha hydroxy acid cream, was evaluated in subjects with mild to severe dyschromia. Digital images were obtained at baseline, 4, 8, and 12 weeks and included assessment of dyschromia, erythema, fine lines/wrinkles, pores, texture, and global improvement. Melanin Index (MI) measurements were obtained at baseline, 4, 8, and 12 weeks. Subject self-assessments were obtained over the course of the study. Adverse Events (AEs) were collected throughout the study. An extension study evaluated use over 16-weeks. Results: Significant mean reductions from baseline occurred in dyschromia for ETCS (n=42) and ETCS + AHA-Ret (n=10) over 12 weeks (P<0.0001, each). Significant mean reductions from baseline in MI were achieved in both groups at every timepoint (ETCS: P<0.0001; ETCS + AHA-Ret: P<0.02, 4 weeks; P<0.0001, 8 and 12 weeks). Substantial improvements were demonstrated in global improvement, fine lines/wrinkles, erythema, pores, and texture at 12 weeks. Reductions from baseline occurred in dyschromia and MI (P<0.0001, each) at 16 weeks. High levels of subject satisfaction were reported with nearly all subjects reporting reduced appearance of uneven skin tone/discoloration and lightened darker patches, and improvement in overall skin tone. Mild, transient AEs were reported with no discontinuations due to an AE. Conclusions: Twice daily use of ETCS led to early, significant reductions in dyschromia and melanin index. Combination use with a retinoid-based, AHA cream in the evening demonstrated enhanced reductions. ETCS effectively reduced hyperpigmentation, improved overall skin appearance, and was highly tolerable. J Drugs Dermatol. 2019;18(7):642-648.

Comparison of 311-nm Titanium:Sapphire laser and 308-nm excimer laser treatment for vitiligo: A randomized controlled non-inferiority trial.

OBJECTIVES: The 308-nm excimer laser (EL) has been widely used for localized vitiligo. The recently developed Titanium:Sapphire laser, emits a wavelength of 311 nm, would be expected to be as effective as excimer laser in treatment of vitiligo but few controlled trials have been reported. We sought to compare the efficacy and safety of the TSL and EL as vitiligo treatments. METHODS: A randomized controlled non-inferiority trial based on split-body was conducted. Patients with stable vitiligo between June 2016 and May 2017 were enrolled. Paired symmetrical vitiligo lesions were randomized to either the EL or TSL treatment group, and treated with a 308-nm EL or a 311-nm TSL twice weekly for 12 weeks. The extent of repigmentation was assessed every 4 weeks, and the non-inferiority margin was set to 10%. We also recorded any adverse events. RESULTS: Seventy-four paired lesions in 21 patients were assigned to both the EL group or TSL group. The mean difference between two groups (EL minus TSL) was -2.862%, and the 95% confidence interval (-6.531% to 0.807%) was lower than the non-inferiority margin. No serious adverse events were noted in either group. CONCLUSIONS: The Titanium:Sapphire laser showed similar therapeutic effect to excimer laser in localized vitiligo with good safety profiles in this non-inferiority randomized controlled trial. The Titanium: Sapphire laser can serve as an alternative treatment option for localized vitiligo. Lasers Surg. Med. 51:239-244, 2019. © 2019 Wiley Periodicals, Inc.

Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study.

BACKGROUND: Juvéderm Vollure XC (VYC-17.5L) belongs to a family of nonanimal hyaluronic acid (HA) gels based on the Vycross technology platform. OBJECTIVE: To evaluate the safety and effectiveness of VYC-17.5L for correction of moderate to severe nasolabial folds (NLFs) compared with a control HA dermal filler. METHODS: In this double-blind study, 123 adults with 2 moderate or severe NLFs as measured on the 5-point photonumeric NLF severity scale (NLFSS) were randomized to VYC-17.5L in 1 NLF and control in the contralateral NLF. The coprimary effectiveness end points at Month 6 were difference in improvement in mean NLFSS score for VYC-17.5L versus control and NLFSS responder rate (≥1-point improvement) for VYC-17.5L. RESULTS: The coprimary effectiveness end points were met. NLFSS scores improved by 1.4 with VYC-17.5L and by 1.3 with control; NLFSS responder rate with VYC-17.5L was 93.2%. More than three-quarters of subjects (82%) treated with VYC-17.5L were very satisfied at Month 6. Investigators reported that VYC-17.5L was smoother and more natural looking and easier to inject and mold than control. VYC-17.5L resulted in significantly fewer severe injection site responses than control. CONCLUSION: VYC-17.5L was safe and effective for correcting moderate to severe NLFs, with results lasting through 6 months in 93% of subjects.

Considerations When Treating Cosmetic Concerns in Men of Color.

BACKGROUND: Men of color include a diverse population encompassing individuals with Fitzpatrick skin Types IV through VI. Yet, there is a paucity of data describing the cosmetic concerns of this population. OBJECTIVE: To review the basic science of advantages and disadvantages of skin of color and pathophysiology, incidence, and treatment of disorders of cosmetic concern in men of color. METHODS: A MEDLINE search was performed for publications on sex and racial differences in basic science of skin, common disorders in men of color, and evidence-based treatments. RESULTS: There are intrinsic differences in skin and hair of darker-complexioned men, particularly in Hispanics, African Americans, Asians, and Afro-Caribbeans. Advantages of darker skin include increased photoprotection, slowed aging, and a lower incidence of skin cancer. However, the increased content of melanin is associated with myriad dyschromias including melasma and postinflammatory hyperpigmentation (PIH). Additional common skin conditions of concern in men of color include pseudofolliculitis barbae, acne keloidalis nuchae, and keloids. CONCLUSION: A skin color conscious approach should be administered in caring for the cosmetic concerns of men of color that is cognizant of differences in biology of the skin and hair, associated PIH of disorders, and cultural/social practices among this population.