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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperpigmentation; Melasma; Peeling; Solar Lentigo
• Intervention / Treatment: Procedure: Glycolic acid peel alone; Other: MelaB3 serum

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margot Broallier, Clinical Trial Manager; Phone Number: +33149643136; Email: margot.broallier@loreal.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Women and men
2. From 30 to 70 years of age (inclusive)
3. Good general health
4. With any type of phototype

5. Hyperpigmentation condition with average darkness > 3:

   1. Epidermal or mixed melasma (determined by Wood's lamp examination at screening), mild to moderate melasma (IGA 1 or 2)
   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
   3. Solar lentigo (SL) with a pigmentation score>5
6. Willingness to protect oneself from the sun as much as possible for the duration of the study
7. Willingness to avoid contraindicated products (irritants, other depigmenting agents)
8. Signing of written informed consent

Exclusion Criteria:

1. Pregnant, breastfeeding or with pregnancy plans.
2. All contraindications for superficial peeling (for example, concomitant infectious processes or inflammatory processes that affect the skin barrier).
3. Melasma with predominance of the pigmentary component at the dermis level, observed with Wood's light at the inclusion visit.
4. Active acne with 10 or more inflammatory lesions.
5. In the case of melasma, participants with recent change of contraception (less than 3 months) or less than 3 months since childbirth.
6. Participant using irritating products (require a washout period of at least 2 weeks).
7. Use of medications that may induce melasma, such as antiepileptics (requires a washout period of 1 month).
8. Use of other products with depigmenting activity (requires a washout period of 1 month).
9. 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.
10. Topical treatments applied to the face (requires a 2-week washout period).
11. Scheduled facial procedures during the course of the study.
12. Participants undergoing phototherapy (requires a 1-month washout period).
13. Known hypersensitivity to study products.
14. 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.
15. Facial treatment with microdermabrasion within 6 weeks prior to study entry.
16. 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.
17. History of skin cancer, immunosuppression or immunodeficiency disorders (including HIV infection or AIDS), or current use of immunosuppressive drugs.
18. Uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism or hypothyroidism. Persons with multiple health conditions may be excluded, even if controlled by diet or medication.
19. Participation in another clinical trial within one week prior to entering this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Group; Peeling Alone	Procedure: Glycolic acid peel alone; Glycolic acid peeling 35% at Baseline
Experimental: MelaB3 serum Group; MelaB3 serum + peeling	Procedure: Glycolic acid peel alone; Glycolic acid peeling 35% at Baseline; Other: MelaB3 serum; Application of a serum MelaB3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy on Signs of Anti-ageing	Using a Visual Analogical scale from 0 to 10 for each parameter: Fine lines and wrinkles; Pores; Skin smoothness; Skin tone, evenness and luminosity; Skin firmness and elasticity	Day-15, Day0, Day28, Day56, Day84
Local Tolerance	Clinical signs (erythema, dryness, and desquamation) assessed by Investigator Symptoms of local skin irritation (itching, tingling, and burning sensation) will be assessed by the patient using 5-level scoring scales from 0 to 3 (0/ 0,5 / 1/ 2/ 3): No signs of irritation (no erythema/dryness/desquamation) 0 Doubtful signs of irritation (doubtful erythema/dryness/desquamation) 0.5 Mild signs of irritation (mild erythema/dryness/desquamation) 1 Moderate signs of irritation (moderate erythema/dryness/desquamation) 2 Severe signs of irritation (severe erythema/dryness/desquamation) 3	Day-15, Day0, Day28, Day56, Day84
Quality of Life (Dermatology Life Quality Index - DLQI)	DLQI questionnaire : Ten questions about the impact of skin disease on quality of life over the last week. Each question is scored on a four-point Likert scale: Very much = 3; A lot = 2; A little = 1; Not at all = 0; Not relevant = 0; Question unanswered = 0; Question 7, 'prevented work or studying' scored 3 The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.	Day-15, Day28, Day84
Instrumental assessment - Colorimetric measurement with Chromameter	Instrumental assessment with Chromemeter Colorimetric measurements will be performed at each assessment visit in accordance with the study site's Standard Operating Procedures (SOPs). Three (3) areas will be assessed: Affected Exposed Area: average of 2 facial lesions with a diameter greater than 2 mm. Unaffected Exposed Area: Average of 2 distinct areas. Unaffected Unexposed Area: One single area (buttock area or inner arm). Skin color will be measured using a portable computer-controlled colorimeter Chromameter® CR 400 (Konica-Minolta, Osaka, Japan), using the L*a*b* color space, where: L* represents luminosity (L* = 0 corresponds to black and L* = 100 indicates diffuse white),; a* indicates the position between green and red (negative values indicate green, and positive values indicate red),; b* indicates the position between blue and yellow (negative values indicate blue, and positive values indicate yellow).	Day-15, Day0, Day28, Day56, Day84
Stigmatization questionnaire (Patient Unique Stigmatization Holistic tool -PUSH-D)	This questionnaire refers to the last 4 weeks. 17 questions. All of the claims are related to your skin condition. It is important that you answer each one spontaneously, based on what you feel or perceive. If any statement does not fit your reality at all, mark "Not applicable". Frequency 4 Very often 3 Often 2 Sometimes 1 Rarely 0 Never	Day-15, Day 28, Day 84

Collaborators and Investigators

• Sponsor: Cosmetique Active International

Study record dates

Study Major Dates

• Study Start (Estimated): March 4, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Skin and Connective Tissue Diseases; Melanosis; Hyperpigmentation
• Other Study ID Numbers: LRP24058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No