Brightening and Improvement of Facial Skin Quality in Healthy Female Subjects With Moderate Hyperpigmentation or Dark Spots and Moderate Facial Aging

December 2018 | Volume 17 | Issue 12 | Original Article | 1310 | Copyright © 2018

Monica Serra,a Bohnert Krista,a Mridvika Narda PhD,b Corinne Granger MD,b Neil Sadick MDc

aSadick Dermatology and Research, New York, NY bInnovation and Development, ISDIN S.A., Barcelona, Spain cWeill Cornell Medical College, Cornell University; Sadick Dermatology and Research, New York, NY

Abstract

OBJECTIVE: To evaluate the safety and efficacy of ISDINCEUTICS Melaclear® serum (Barcelona, Spain) on skin brightness, skin quality, and signs of facial aging. DESIGN: This was a single-center, observational, open label, prospective clinical study. Ten healthy females (ages 30-70) with moderate signs of facial aging and moderate photodamage (hyperpigmentation and/or sun spots) were enrolled. Treatment consisted of topical twice-daily application of Melaclear serum, morning and evening, to the face and neck for 12 weeks. Efficacy assessments were conducted at weeks 4, 8, and 12. Standardized photographs, expert investigator grading, tolerability assessments, and subjects reported outcome measures were performed at all visits. Adverse events (AEs) were monitored throughout. Visual assessments of the face and neck included grading for radiance, smoothness, pigmentation, erythema, pore size, skin clarity, skin brightness, skin tone, luminosity, skin complexion, photodamage, hyperpigmentation, wrinkle severity, pigment via the modified Melasma Area and Severity Index (MASI), and overall global aesthetic improvement (GAIS). Safety and tolerability assessments included an evaluation of face and neck for stinging/burning by the subject and dryness, scaling, edema, and erythema by the treating investigator at all study visits. RESULTS: All enrolled subjects completed the study. At the 8 and 12-week follow up visit, there was a statistically significant improvement in the investigator GAIS (1.1 and 1.3, respectively) for the face from baseline. MASI scores were all statistically significantly reduced in the face from week 8 onward relative to baseline. In addition, all skin quality parameters assessed in the face significantly improved from baseline to week 12. Subject global aesthetic improvement scale scores (SGAIS) were also significantly improved at week twelve from baseline (1.8 change) as were skin quality assessments. The average rating for patient satisfaction was 2, or "satisfied" with the overall treatment effectiveness from week 4 onwards. For the neck none of the investigator or subject assessments improved significantly at any time point. No adverse events, tolerability events, or unexpected side effects were observed or reported for any of the subjects. CONCLUSION: Twice a day treatment of women with moderate facial photoaging and hyperpigmentation with Melaclear serum can significantly improve skin quality, reduce the severity and intensity of hyperpigmentation, and improve signs of photodamage within 12 weeks without any side effects. J Drugs Dermatol. 2018;17(12):1310-1315.

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INTRODUCTION

The natural aging process, regardless of an individual’s genetic disposition and lifestyle, leads to a variety of skin manifestations such as dyschromias, change in pore size, lines, textural irregularities, loss of skin elasticity, and firmness that is mostly evident on the face and neck. External factors like long-term exposure to sunlight (ultraviolet A and B) can aggravate aging, a condition commonly referred to as photoaging and photodamage, and lead to more severe cuta- neous disorders including actinic keratosis, skin cancer, and melasma. As a blemish free, clear, even-toned skin is a universal indication of health and beauty, the effects of photoaging have a significant negative impact on women, leading to emotional distress and a decline in quality of life.1,2 To date multiple treatment modalities have been employed to address these concerns including topical preparations, chemical peels, lasers, energy-based devices, and a combination thereof. While chemical peels and energy-based devices, together with rigorous sun protection, have proven largely effective in improving the signs of photoaging, they require in-office visits as well as allocating an appreciative budget to this end. Topical treatments of photoaging on the other hand offer the advantage of reduced cost and ease of use, thus tend to be more popular with the wide population. The goal of topical formulations is to penetrate the stratum corneum and reduce the production and distribution of epidermal melanin. For a long time, the first line agent of treatment has been the tyrosinase inhibitor hydroquinone (HQ) that produces reversible 

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