An interventional study of Depigmenting Cosmetic Serum (Applied Morning and Evening) in Healthy, Melasma (Facial Melasma) and Epidermal Melasma, sponsored by Laboratoire Dermatologique ACM. Recruiting at 1 site in Mauritius. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Laboratoire Dermatologique ACM · Not applicable, Interventional, and Treatment
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
Melasma is a chronic hyperpigmentation disorder of multifactorial origin, often aggravated by ultraviolet (UV) radiation, hormonal changes, and inflammation. It predominantly affects individuals with Fitzpatrick skin phototypes III to V and manifests as irregular brown macules and patches, particularly on sun-exposed facial areas. While 4% hydroquinone remains the gold standard topical agent for melasma, its long-term use is associated with adverse events such as irritant dermatitis and exogenous ochronosis, prompting the development of alternative dermocosmetic formulations.
This double-blind, randomized, controlled trial investigates the comparative efficacy and cutaneous tolerance of an intensive anti-spot cosmetic serum (Depiwhite Serum) versus a hydroquinone 4% cream (Eldopinone), both used in conjunction with a high-protection SPF50+ sunscreen (Depiwhite.M). The serum incorporates a combination of active ingredients designed to target melanogenesis and its upstream mediators through a multi-pathway mechanism, including anti-inflammatory, antioxidant, and melanin-regulatory actions.
The study will evaluate changes in melasma severity using a modified Melasma Area and Severity Index (mMASI) score and standardized facial photography acquired with the ColorFace® imaging system. These photographs will undergo high-resolution colorimetric analysis by QIMA Life Sciences, quantifying pigmentation changes through CIELab parameters (L*, a*, b*), ITA°, and contrast metrics (ΔE76, ΔITA°, etc.), tracked across predefined regions of interest (ROIs) from lesional and perilesional skin.
Additional assessments include subjective product performance evaluation, cosmetic acceptability, and patient-reported outcomes using two validated quality-of-life instruments (MELASQoL and ASLQI). Safety and local tolerance will be monitored at each clinical visit via dermatologist-led skin examinations and subject-reported functional symptoms.
The trial aims to generate robust clinical and instrumental data supporting the use of cosmetic formulations as a potential alternative or maintenance therapy to hydroquinone in melasma management, particularly for populations seeking better tolerability profiles without compromising efficacy.
Amendment Note (15 August 2025 The inclusion criteria have been revised to allow subjects with a baseline mMASI score of ≥3.5 (previously ≥4) to accommodate borderline moderate melasma cases. This change is reflected in Protocol Version 2.0.
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 157 interventional studies indexed under Melanosis.
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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.
Male or female subjects, primarily female, aged 18 to 65 years at the time of inclusion
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
Willing and able to comply with study procedures and scheduled visits
Women of must agree to use a reliable method of for at least 3 months prior to and during the entire study duration
Exclusion Criteria:
Presence of post-inflammatory hyperpigmentation (PIH), lentigines, or other non-melasma facial pigmentation
Use of topical or systemic depigmenting treatments, retinoids, , or hormonal treatments within 4 weeks prior to baseline
Known allergy or to any component of the 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 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
> 40 or other conditions that may affect protocol compliance as judged by the investigator
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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)
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.
Time frame: 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.
Change in modified Melasma Area Severity Index (mMASI) at Day 56
Clinical evaluation of melasma severity on each hemi-face using the modified mMASI score, comparing baseline to Day 56. Unit of measure: Score(0-24)
Time frame: Day 56
Change in Individual Typology Angle (ITA°) from baseline
Evaluation of melasma pigmentation using ITA° from standardized ColorFace® photographs. Two Regions of Interest (ROI) are analyzed: one in melasma-affected skin and one in adjacent healthy skin. Unit of Measure: Degrees (°)
Time frame: Day 56 and Day 84
Change in Melasma Quality of Life Index (MELASQoL)
Subjects complete the MELASQoL questionnaire to evaluate the emotional and social impact of melasma. Unit of Measure: Score (7-70)
Time frame: Day 56 and Day 84
Subject-rated product efficacy and cosmetic acceptability
Subjects assess perceived product performance (e.g., brightness, evenness, spot reduction) and cosmetic acceptability using a structured questionnaire. Unit of Measure: Score on 4-point scale
Time frame: Day 28, Day 56, and Day 84
Investigator-assessed dermatological tolerance
Evaluation of local intolerance signs (e.g., erythema, dryness, desquamation) by dermatologist using a standardized clinical scale. Unit of Measure: Severity score (0-4 scale)
Time frame: Day 56 and Day 84
Subject-reported local intolerance symptoms
Description: Subjects report symptoms such as burning, itching, stinging, and tightness on the face using a self-assessment scale. Unit of Measure: Severity score (0-4 scale)
Time frame: Day 56 and Day 84
Plan to share: No — Individual Participant Data (IPD) will not be shared for this study. The trial involves cosmetic products and is not subject to regulatory requirements mandating data sharing. Additionally, participant privacy and confidentiality are prioritized, and the data collected are not intended for secondary research use.
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