Efficacy and Tolerability of an Acne Treatment Regimen with Antiaging Benefits in Adult Women: A Pilot Study.

Objective: The objective of this study was to assess clinical safety and efficacy of a novel acne treatment regimen in adult women. Methods: Participants in the study included an ethnically diverse group of adult women (n=24) with mild-to-moderate acne who were treated twice daily with a topical regimen (cleanser, acne cream, and rebalancing gel) for eight weeks. Following baseline assessments, subjects returned to clinic at Weeks 2, 4, and 8 for clinical assessments and self-assessment questionnaires. Results: Twenty-one of the 24 enrolled women completed the eight-week clinical trial. Statistically significant clinical improvements were seen in both acne and aging parameters over time. The product regimen was well tolerated without adverse reactions commonly seen with topical acne products. Conclusion: The regimen demonstrated efficacy and tolerability in adult women with acne and signs of skin aging.

Efficacy of Trifecting® Night Cream, a Novel Triple acting Skin Brightening Product: A Double-blind, Placebo-controlled Clinical Study.

Background: Melasma is a common, persistent disorder of hyperpigmented facial skin predominantly attributed to ultraviolet light exposure, hormonal influences, and genetic predisposition. Objectives: This double-blind, placebo-controlled, randomized clinical trial was conducted to assess the efficacy and tolerance of a multimodality night cream when used over a course of 24 weeks followed by a four-week regression in female subjects with moderate to severe melasma, presence of solar lentigines, and periocular lines and wrinkles. Methods: Subjects were randomized into one of two groups: Cell 1 received Trifecting® Night Cream (Envy Medical, Long Beach, California) 1.0 and Cell 2 did not. All subjects were supplied with a two-product regimen comprising a cleanser and sunscreen to use during the trial. Clinical grading, tolerability assessments, and Chroma Meter measurements (Konica Minolta, Tokyo, Japan) were performed at baseline and at Weeks 8, 16, 24, and 28 (regression). Standardized digital photographs were taken and self-assessment questionnaires were completed. Results: Twenty-five subjects completed the 28-week study, with 14 subjects in Cell 1 and 11 subjects in Cell 2. Subjects in both groups showed improvements in facial conditions. Cell 1 outperformed Cell 2 in improving fine lines, solar lentigines, and melasma conditions. These improvements were sustained during regression period. Conclusions: Trifecting® Night Cream 1.0, is effective for the treatment of moderate to severe melasma, solar lentigines, and periocular lines and wrinkles over 24 weeks of usage, with its benefits sustained for at least four weeks after treatment.

A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating an Oral Anti-aging Skin Care Supplement for Treating Photodamaged Skin.

OBJECTIVE: Evaluate an anti-aging skin care supplement on the appearance of photodamaged skin. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. Following a one-month washout period, subjects received two anti-aging skin care formula tablets (total daily dose: marine complex 210mg, vitamin C 54mg, zinc 4mg) or placebo daily for 16 weeks. Subjects were restricted from products/procedures that may affect the condition/appearance of skin, including direct facial sun or tanning bed exposure. PARTICIPANTS utilized a standardized facial cleanser and SPF15 moisturizer. SETTING: Single study center (Texas, United States; June-November 2007). PARTICIPANTS: Healthy women aged 35 to 60 years (mean, 50 years), Fitzpatrick skin type I-IV, modified Glogau type II-III. MEASUREMENTS: Subjects were assessed at Weeks 6, 12, and 16 on clinical grading (0-10 VAS), bioinstrumentation, digital photography, and self-assessments. Analysis of variance with treatment in the model was used for between-group comparisons (alpha P≤0.05). RESULTS: Eighty-two anti-aging skin care formula subjects and 70 placebo subjects completed the study. Significant differences in change from baseline to Week 16 scores were observed for clinical grading of overall facial appearance (0.26; P<0.0001), radiant complexion (0.59; P<0.0001), periocular wrinkles (0.08; P<0.05), visual (0.56; P<0.0001) and tactile (0.48; P<0.0001) roughness, and mottled hyperpigmentation (0.15; P<0.001) favoring the subjects in the anti-aging skin care supplement group. Ultrasound skin density (Week 16) was significantly reduced for placebo versus anti-aging skin care supplement group (-1.4% vs. 0%; P<0.01). Other outcomes were not significant. Mild gastrointestinal symptoms possibly related to the anti-aging skin care supplement (n=1) and placebo (n=2) were observed. CONCLUSION: Women with photodamaged skin receiving anti-aging skin care supplement showed significant improvements in the appearance of facial photodamage. TRIAL REGISTRY: Not applicable. Study precedes FDAAA 801 clinical trial registration and results submission requirements.

Development and Clinical Assessment of a Comprehensive Product for Pigmentation Control in Multiple Ethnic Populations.

BACKGROUND: Pigmentary changes in people of different ethnic origins are controlled by slight variations in key biological pathways leading to different outcomes from the same treatment. It is important to develop and test products for desired outcomes in varying ethnic populations. OBJECTIVES: To develop a comprehensive product (LYT2) that affects all major biological pathways controlling pigmentation and test for clinical efficacy and safety in different ethnic populations. METHODS: A thorough analysis of biological pathways was used to identify ingredient combinations for LYT2 that provided optimal melanin reduction in a 3-D skin model. Expression of four key genes for melanogenesis, TYR, TYRP-1, DCT, and MITF was analyzed by qPCR. Clinical study was conducted to compare the efficacy and tolerability of LYT2 against 4% hydroquinone (HQ). RESULTS: Average melanin suppression by LYT2 in 7 independent experiments was 45%. All four key genes show significant down- regulation of expression. LYT2 provided statistically significant reductions in mean overall hyperpigmentation grades as early as week 2 compared to baseline, with continued significant improvements through week 12 in all ethnic groups tested. CONCLUSION: We have successfully combined management of 6 categories of pathways related to melanogenesis: melanocyte activation, melanosome development, melanin production, melanin distribution, keratinocyte turnover, and barrier function to create a comprehensive HQ-free product. The outcome clearly shows greater pigmentation control with LYT2 compared to other HQ-free products in skin tissue models and earlier control in clinical studies compared to 4% HQ. Clinical study shows pigmentation control benefits of LYT2 in people of Caucasian, Hispanic, and African ethnic origins. J Drugs Dermatol. 2016;15(12):1562-1570.

Protective effects of a topical antioxidant mixture containing vitamin C, ferulic acid, and phloretin against ultraviolet-induced photodamage in human skin.

BACKGROUND: Ultraviolet (UV) irradiation of the skin leads to acute inflammatory reactions, such as erythema, sunburn, and chronic reactions, including premature skin aging and skin cancer. AIM: In this study, the effects of a topical antioxidant mixture consisting of vitamin C, ferulic acid, and phloretin on attenuating the harmful effects of UV irradiation on normal healthy volunteers were studied using biomarkers of skin damage. SUBJECTS/METHODS: Ten subjects (age, 18-60 years; Fitzpatrick skin types II and III) were randomized and treated with antioxidant product or vehicle control on the lower back for four consecutive days. On day 3, the minimal erythema dose (MED) was determined for each subject at a different site on the back. On day 4, the two test sites received solar-simulated UV irradiation 1-5x MED at 1x MED intervals. On day 5, digital images were taken, and 4-mm punch biopsies were collected from the two 5x MED test sites and a control site from each subject for morphology and immunohistochemical studies. RESULTS: UV irradiation significantly increased the erythema of human skin in a linear manner from 1x to 5x MED. As early as 24 h after exposure to 5x MEDs of UV irradiation, there were significant increases in sunburn cell formation, thymine dimer formation, matrix metalloproteinase-9 expression, and p53 protein expression. All these changes were attenuated by the antioxidant composition. UV irradiation also suppressed the amount of CD1a-expressing Langerhans cells, indicating immunosuppressive effects of a single 5x MED dose of UV irradiation. Pretreatment of skin with the antioxidant composition blocked this effect. CONCLUSION: This study confirms the protective role of a unique mixture of antioxidants containing vitamin C, ferulic acid, and phloretin on human skin from the harmful effects of UV irradiation. Phloretin, in addition to being a potent antioxidant, may stabilize and increase the skin availability of topically applied vitamin C and ferulic acid. We propose that antioxidant mixture will complement and synergize with sunscreens in providing photoprotection for human skin.