January 29, 2019

For facial assessments, the investigators found a significant improvement in GAIS scores across all time points from baseline to week 12.

According to study results published in the Journal of Drugs in Dermatology, Melaclear® serum used on the face with sun protection can improve skin quality, prevent photoaging, and help fight signs of facial aging.

The investigators of this single-center, observational, open-label study sought to assess the effectiveness and safety of a new generation non-tyrosinase topical agent  to brighten facial skin and improve skin quality, as well as reduce signs of facial aging.

The study sample included 10 healthy women, aged 30 to 70 years, from Barcelona, Spain with moderate photodamage (hyperpigmentation, sunspots) and signs of facial aging. Participants applied topical Melaclear serum twice daily — once in the morning and once in the evening — to the face and neck, along with sun protection, for 12 weeks.

Efficacy and tolerability outcomes were assessed at 4, 8, and 12 weeks using standardized photographs, expert investigator grading, and tolerability assessments. Visual examination of the face and neck assessed skin quality parameters, including radiance, smoothness, pigmentation, erythema, pore size, clarity, brightness, skin tone, luminosity, and complexion. Changes in wrinkle severity, photodamage, and hyperpigmentation, as well as Dermatologic Quality of Life, were further assessed.

The primary study end point was overall improvement in skin quality measured using the Global Aesthetic Improvement Scale (GAIS). Secondary end points evaluated a change in pigmentation via the modified Melasma Area and Severity Index (mMASI) and in Skin Quality Assessments. Treatment-related adverse events were reported throughout the study as safety outcomes, and tolerability was evaluated for the presence of stinging, burning, dryness, scaling, edema, and erythema.

For facial assessments, the investigators found a significant improvement in GAIS scores across all time points from baseline to week 12 (GAIS 1.3±0.6; P =.01), and a significant reduction in mMASI scores from week 8 onward. All investigator assessments of facial skin quality, photoaging, and hyperpigmentation showed significant improvement from baseline to week 12. Evaluated by the participants, GAIS scores and skin quality assessments improved from baseline to end of the study, and quality of life scores improved by 1.7 points; the average patient satisfaction rating for overall treatment efficacy was 2, or “satisfied.”

Investigator and participant assessments for the neck indicated mild improvement in skin quality but were not statistically significant at any time point. No adverse or unexpected events were reported over the course of study, and Melaclear serum was well tolerated.

Limitations to the study included a small sample size and short follow-up period. In addition, the mMASI test was not developed for the neck area and may not be optimal to measure changes in neck pigmentation.

After 3 months of treatment, Melaclear serum used twice daily with sun protection was well-tolerated and effective for improvement of facial skin quality and for the reduction of appearance of photodamage and hyperpigmentation in women with signs of facial aging. Future studies should compare Melaclear serum with traditional therapies in a larger sample of patients.

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Reference

Serra M, Krista B, Narda M, Granger C, Sadick N. Brightening and improvement of facial skin quality in healthy female subjects with moderate hyperpigmentation or dark spots and moderate facial aging. J Drugs Dermatol. 2018;17(12):1310-1315.