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COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS

NCT07071363 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-20

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the dermatological tolerance and skin-lightening efficacy of a cosmetic depigmenting serum to a 4% hydroquinone-based product in adult male and female subjects aged 18-65 years with mild to moderate epidermal or mixed-type melasma.

The main questions it aims to answer are:

Does the cosmetic serum reduce the severity of melasma (measured by mMASI) after 84 days of use?

Is the cosmetic serum better tolerated than 4% hydroquinone under real-use conditions?

Researchers will compare the serum group and the hydroquinone group to determine whether the cosmetic product achieves comparable pigmentation improvement with superior skin tolerability.

Participants will:

Group 1: Apply a morning routine (Depiwhite Serum + Depiwhite M SPF50+ cream) Apply an evening routine (Depiwhite Serum + Placebo Cream without Hydroquinone)

Group 2: Apply a morning routine (Serum Placebo + Depiwhite M SPF50+ cream) Apply an evening routine (Serum Placebo + Depigmenting Cream with hydroquinone 4%)

Visit the clinical site at baseline (Day 0), Day 56, and Day 84 for assessments

Complete standardized photographs, self-assessment questionnaires, and quality-of-life surveys (MELASQoL and ASLQI)

Undergo clinical evaluations by a dermatologist, including mMASI scoring and tolerance assessment

Conditions

  • Healthy
  • Melasma (Facial Melasma)
  • Epidermal Melasma

Interventions

DRUG

Depigmenting Cosmetic Serum (Applied Morning and Evening)

Participants in Group 1 receive a depigmenting cosmetic serum with non-drug actives applied morning and evening, plus a placebo cream without hydroquinone applied in the evening. Group 2 receives a placebo serum (no active depigmenting ingredients) applied morning and evening, and a hydroquinone 4% cream applied in the evening. All participants apply an SPF50+ sunscreen in the morning throughout the 84-day study. The cosmetic serum is the investigational product; hydroquinone serves as the active comparator. Placebo products are visually matched to their respective actives to ensure blinding. The study distinguishes each intervention by active ingredients, timing of application (morning/evening), and role (test vs. reference vs. supportive care). All products are applied topically, and the regimen remains fixed across the study duration.

Sponsors & Collaborators

  • CIDP Mauritius

    collaborator UNKNOWN

  • Laboratoire Dermatologique ACM

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-23
Primary Completion
2025-10-31
Completion
2025-12-22

Countries

  • Mauritius

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07071363 on ClinicalTrials.gov