NCT07429786

Evaluation of Efficacy and Tolerabilty of MelaB3 Serum in Combination of 35% Glycolic Acid Peeling Compared to 35% Glycolic Acid Peeling Alone in Various Hyperpigmentation Conditions

Randomized Clinical Trial to Assess the Effectiveness and Tolerability of MELA B3 Serum in Combination With 35% Glycolic Acid Peel vs. 35% Glycolic Acid Peel for the Treatment of Various Hyperpigmentation Conditions (Melasma, Post-inflammatory Hyperpigmentation and Solar Lentigo) and Signs of Aging in a Population of Participants From the Autonomous City of Buenos Aires, Argentina.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Randomized clinical trial to assess the effectiveness and tolerability of Mela B3 serum in combination with 35% glycolic acid peel vs. 35% glycolic acid peel for the treatment of various hyperpigmentation conditions (melasma, post-inflammatory hyperpigmentation and solar lentigo) and signs of aging in a population of participants from the Autonomous City of Buenos Aires, Argentina.

Detailed description

Interventional, monocentric, randomized, parallel-group, full-face clinical trial to analyze the effect of MB3 serum in combination with GAP 35 vs. GAP 35 alone. * Group A: GAP 35 on Day0 + post-peel * Group B: MB3 serum from Day-15 to Day84 + GAP 35 on D0 + post-peel Duration: 99 days Visits: Day-15, Day0, Day28, Day56, Day84 (5 visits) Evaluations: * To evaluate the occurrence and severity of post-procedure pigmentation changes, including the development or worsening of PIHP, melasma and solar lentigo, following treatment with MB3 serum and GAP35 determined by change in mMASI, PAHPI socre and SL score. * To demonstrate the effectiveness of MB3 serum in combination (pre- and post-treatment) with GAP 35 in the treatment of the signs of skin aging: * Fine lines and wrinkles * Pores * Skin smoothness * Skin tone, evenness and luminosity * Skin firmness and elasticity * Skin flaccidity * To assess the tolerability of MB3 serum in combination with GAP 35 * To evaluate the quality of life of subjects using QOL (quality of Life) questionnaires * To evaluate the satisfaction of the participants with MB3 serum and cosmeticity using patient satisfaction questionnaire and cosmeticity questionnaire. * To evaluate the changes in skin pigmentation using colorimeter measurements in areas affected by melasma, PIH and SL before and after treatment with MB3 serum and GAP35. * To illustrate the efficacy of the treatment determined by using VISIA imaging.

Conditions

• Hyperpigmentation
• Melasma
• Solar Lentigo
• Peeling

Interventions

Type	Name	Description
PROCEDURE	Glycolic acid peel alone	Glycolic acid peeling 35% at Baseline
OTHER	MelaB3 serum	Application of a serum MelaB3

Timeline

• Start date: 2026-03-04
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-02-24
• Last updated: 2026-02-24