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

NCT07429786 | Not Yet Recruiting

• 1 other identifier: LRP24058
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hyperpigmentation; Melasma; Solar Lentigo; Peeling

Outcome Measures

Primary Outcomes (1)

• Efficacy on hyperpigmentation severity

  To demonstrate the effectiveness of Mela B3 serum (MB3 serum) in combination (before and after treatment) with 35% glycolic acid peel (GAP 35) compared to 35% glycolic acid peel alone in the treatment of hyperpigmentation in three conditions: melasma, post-inflammatory hyperpigmentation (PIHP) and solar lentigo (SL) over 3 months' usage when compared to baseline determined by IGA, mMASI, PAHPI and Solar lentigo score.

  Day-15, Day0, Day28, Day56, Day84

Secondary Outcomes (5)

• Efficacy on Signs of Anti-ageing

  Day-15, Day0, Day28, Day56, Day84

• Local Tolerance

  Day-15, Day0, Day28, Day56, Day84

• Quality of Life (Dermatology Life Quality Index - DLQI)

  Day-15, Day28, Day84

• Instrumental assessment - Colorimetric measurement with Chromameter

  Day-15, Day0, Day28, Day56, Day84

• Stigmatization questionnaire (Patient Unique Stigmatization Holistic tool -PUSH-D)

  Day-15, Day 28, Day 84

Study Arms (2)

Control Group

EXPERIMENTAL

Peeling Alone

Procedure: Glycolic acid peel alone

MelaB3 serum Group

EXPERIMENTAL

MelaB3 serum + peeling

Procedure: Glycolic acid peel alone; Other: MelaB3 serum

Interventions

Glycolic acid peel alone PROCEDURE

Glycolic acid peeling 35% at Baseline

Control Group; MelaB3 serum Group

MelaB3 serum OTHER

Application of a serum MelaB3

MelaB3 serum Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men
• From 30 to 70 years of age (inclusive)
• Good general health
• With any type of phototype
• Hyperpigmentation condition with average darkness \> 3:
• Epidermal or mixed melasma (determined by Wood's lamp examination at screening), mild to moderate melasma (IGA 1 or 2)
• Post acne inflammatory hyperpigmentation (PIHP), mild to moderate (IGA 1 or 2) with no active acne and less than 10 inflammatory lesion on full face
• Solar lentigo (SL) with a pigmentation score\>5
• Willingness to protect oneself from the sun as much as possible for the duration of the study
• Willingness to avoid contraindicated products (irritants, other depigmenting agents)
• Signing of written informed consent

You may not qualify if:

• Pregnant, breastfeeding or with pregnancy plans.
• All contraindications for superficial peeling (for example, concomitant infectious processes or inflammatory processes that affect the skin barrier).
• Active acne with 10 or more inflammatory lesions.
• In the case of melasma, participants with recent change of contraception (less than 3 months) or less than 3 months since childbirth.
• Participant using irritating products (require a washout period of at least 2 weeks).
• Use of medications that may induce melasma, such as antiepileptics (requires a washout period of 1 month).
• Use of other products with depigmenting activity (requires a washout period of 1 month).
• Other facial dermatoses or known photosensitivity, or a pre-existing or latent dermatologic health condition and/or disease on the face (e.g., psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriations) that, in the judgment of the investigator, are considered inappropriate for participation or may interfere with study results.
• Topical treatments applied to the face (requires a 2-week washout period).
• Scheduled facial procedures during the course of the study.
• Participants undergoing phototherapy (requires a 1-month washout period).
• Known hypersensitivity to study products.
• History of laser resurfacing procedures, intense pulsed light, facial radiofrequency, deep peeling, facial mesotherapy with tranexamic acid, botulinum toxin or dermal filler injections, or cosmetic procedures on the face within 6 months prior to the start of the study.
• Facial treatment with microdermabrasion within 6 weeks prior to study entry.
• Persons with visible tanning, scars, moles, excessive hair or other dermal conditions on the face that, in the judgment of the investigator, may influence the results of the study.

Sponsors & Collaborators

• Cosmetique Active International: lead

MeSH Terms

Conditions

Hyperpigmentation; Melanosis

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Margot Broallier, Clinical Trial Manager

CONTACT

+33149643136; margot.broallier@loreal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 24, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share