ClinicalTrials.gg
Not yet recruitingNCT07429786Updated Feb 24, 2026

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

An interventional study of Glycolic acid peel alone and MelaB3 serum in Hyperpigmentation, Melasma and Solar Lentigo, sponsored by Cosmetique Active International. Not yet recruiting. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Cosmetique Active International (part of L'Oréal) · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Hyperpigmentation by Cosmetique Active International — 6 open to participants now, 6 under way, none of them phase 3. Hyperpigmentation · Cosmetique Active International.

Started
2026
the only one that year
No phase
7 of 11
6 open now
Registered
10th of 11
by date

Among the 11 studies in Hyperpigmentation by Cosmetique Active International, this one is the only one that started in 2026, is one of 7 with no phase, and was the 10th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

No phasethis study7 · 6 open
Observational4 · 0 open

By the year they started

First in 2020; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 67 across the 7 interventional studies, 73 across the 4 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Hyperpigmentation by Cosmetique Active International, or all of them as a file.
02

Study 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.

Read the 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.
03

Conditions studied

  • Hyperpigmentation
  • Melasma
  • Solar Lentigo
  • Peeling
04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 products (irritants, other depigmenting agents)
  8. Signing of written

Exclusion criteria

Exclusion Criteria:

  1. Pregnant, breastfeeding or with pregnancy plans.
  2. All 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 (less than 3 months) or less than 3 months since childbirth.
  6. Participant using irritating products (require a 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 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, or immunodeficiency disorders (including 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Control Group

    Peeling Alone

    Procedure: Glycolic acid peel alone

  • Experimental
    MelaB3 serum Group

    MelaB3 serum + peeling

    Procedure: Glycolic acid peel alone · Other: MelaB3 serum

Interventions

  • ProcedureGlycolic acid peel alone

    Glycolic acid peeling 35% at Baseline

  • OtherMelaB3 serum

    Application of a serum MelaB3

06

What researchers measure

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.

    Time frame: Day-15, Day0, Day28, Day56, Day84

Secondary outcomes

  1. 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

    Time frame: Day-15, Day0, Day28, Day56, Day84

  2. 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

    Time frame: Day-15, Day0, Day28, Day56, Day84

  3. 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.

    Time frame: Day-15, Day28, Day84

  4. 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).

    Time frame: Day-15, Day0, Day28, Day56, Day84

  5. 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

    Time frame: Day-15, Day 28, Day 84

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07429786
Responsible party
Sponsor
First posted
Feb 24, 2026
Start date
Mar 4, 2026 (estimated)
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Feb 24, 2026

Study contacts

Margot Broallier, Clinical Trial Manager
Contact
margot.broallier@loreal.com
+33149643136

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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