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

NCT07071363 | Recruiting

• 1 other identifier: 2425CMCL065
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Melasma; Hyperpigmentation Skin; Pigmentation Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Modified Melasma Area and Severity Index (mMASI) Score From Baseline (Day 0) to Day 84 ±1 Day, Assessed by a Blinded Dermatologist to Evaluate the Clinical Efficacy of the Investigational and Comparator Products in Subjects With Melasma

  The modified Melasma Area and Severity Index (mMASI) is a validated clinical scoring method used to assess the severity and extent of facial melasma. It evaluates four facial regions (forehead, right malar, left malar, and chin) based on the area of involvement and the intensity of pigmentation. Each region contributes proportionally to the total score, which ranges from 0 (no melasma) to 24 (severe melasma). In this study, the mMASI score will be assessed by a blinded dermatologist at baseline (Day 0) and again at Day 84 (±1 day). The primary objective is to quantify the change in mMASI score after 12 weeks of treatment with either the investigational cosmetic serum (Depiwhite Serum) or the comparator product containing hydroquinone 4% (Eldopinone). This outcome will serve as the primary measure of clinical efficacy in reducing melasma severity over the course of the study.

  Baseline (Day 0) to Day 84 ±1 day. The mMASI score will be assessed at both time points by a blinded dermatologist to evaluate the change in melasma severity over the 12-week treatment period.

Secondary Outcomes (6)

• Change in modified Melasma Area Severity Index (mMASI) at Day 56

  Day 56

• Change in Individual Typology Angle (ITA°) from baseline

  Day 56 and Day 84

• Change in Melasma Quality of Life Index (MELASQoL)

  Day 56 and Day 84

• Subject-rated product efficacy and cosmetic acceptability

  Day 28, Day 56, and Day 84

• Investigator-assessed dermatological tolerance

  Day 56 and Day 84

Study Arms (2)

Depiwhite Serum + Placebo Cream

EXPERIMENTAL

Subjects apply Depiwhite Serum (morning and evening) with Depiwhite M SPF50+ cream in the morning and a placebo cream (no hydroquinone) in the evening for 84 days.

Drug: Depigmenting Cosmetic Serum (Applied Morning and Evening)

Placebo Serum + Hydroquinone 4% Cream

ACTIVE COMPARATOR

Subjects apply a placebo serum (morning and evening) with Depiwhite M SPF50+ cream in the morning and hydroquinone 4% cream (Eldopinone) in the evening for 84 days.

Drug: Depigmenting Cosmetic Serum (Applied Morning and Evening)

Interventions

Depigmenting Cosmetic Serum (Applied Morning and Evening) DRUG

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.

Also known as: Hydroquinone 4% Cream (Applied in the Evening), Placebo Serum (Applied Morning and Evening), Placebo Cream (No Hydroquinone, Applied in the Evening), SPF50+ Sunscreen (Applied in the Morning)

Depiwhite Serum + Placebo Cream; Placebo Serum + Hydroquinone 4% Cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fitzpatrick skin phototype II to V
• Diagnosed with mild to moderate epidermal or mixed-type facial melasma, confirmed by Wood's lamp examination
• mMASI score between 3.5 and 13 at baseline
• Subject is in general good health as assessed by the investigator based on medical history and clinical examination
• Willing to avoid excessive sun exposure and use only the provided SPF50+ sunscreen during the study
• Able to understand the study procedures and provide written informed consent
• Willing and able to comply with study procedures and scheduled visits
• Women of childbearing potential must agree to use a reliable method of contraception for at least 3 months prior to and during the entire study duration

You may not qualify if:

• Presence of post-inflammatory hyperpigmentation (PIH), lentigines, or other non-melasma facial pigmentation
• Use of topical or systemic depigmenting treatments, retinoids, corticosteroids, or hormonal treatments within 4 weeks prior to baseline
• Known allergy or hypersensitivity to any component of the investigational or comparator products
• Excessive sun exposure or use of tanning beds within 2 weeks before baseline or planned during the study
• Active skin diseases (e.g., atopic dermatitis, psoriasis) or damaged skin in the test area
• Pregnant or breastfeeding women, or those planning to become pregnant during the study
• Participation in another clinical trial within 4 weeks prior to the study or planned participation in another trial during the study
• History of malignancy in the past 10 years (except treated basal cell carcinoma)
• Uncontrolled systemic illness (e.g., diabetes, cardiovascular, hepatic, renal, or pulmonary disease)
• Any psychological or cognitive condition that would limit the subject's ability to understand the study procedures
• Current use of photosensitizing medications
• BMI \> 40 or other conditions that may affect protocol compliance as judged by the investigator

Sponsors & Collaborators

• Laboratoire Dermatologique ACM: lead
• CIDP Mauritius: collaborator

Study Sites (1)

Centre International de Développement Pharmaceutique

Port Louis, Phoenix, 73408, Mauritius

RECRUITING

MeSH Terms

Conditions

Melanosis; Hyperpigmentation; Pigmentation Disorders

Interventions

hydroquinone

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Gitanjali PETKAR Principal Investigator (Dermatologist), (MBBS, DDV)

CONTACT

+2304012600; g.petkar@cidp-cro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigator is: The principal investigator who was masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, controlled, parallel-group study in which subjects are allocated in a 1:1 ratio to one of two intervention arms for a duration of 84 days. Group 1 (Cosmetic Product Group): Participants apply Depiwhite Serum (intensive anti-spot serum) in the morning followed by Depiwhite M SPF50+ cream and again apply Depiwhite Serum in the evening followed by a placebo cream (free of hydroquinone). Group 2 (Hydroquinone Group): Participants apply a placebo serum (lacking active depigmenting ingredients) in the morning followed by Depiwhite M SPF50+ cream and again apply the placebo serum in the evening followed by Eldopinone cream containing Hydroquinone 4% (USP). Both groups follow this regimen for 84 consecutive days. The primary aim is to compare the effectiveness and dermatological tolerance of the cosmetic product versus hydroquinone in subjects with facial melasma.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 17, 2025
• Study Start: June 23, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 22, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)