HealthyNCT07071363
COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS
A study testing Depigmenting Cosmetic Serum (Applied Morning and Evening) in people with Healthy and Melasma (Facial Melasma), run by Laboratoire Dermatologique ACM at 1 site in Mauritius.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy, Melasma (Facial Melasma), Epidermal Melasma
- What is being tested?
- Depigmenting Cosmetic Serum (Applied Morning and Evening)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMauritius
- Study dates
- 23 Jun 2025to 22 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr Gitanjali PETKAR Principal Investigator (Dermatologist), (MBBS, DDV) contact
Mauritius1 site, 1 recruiting
- Recruiting
Centre International de Développement Pharmaceutique
Port Louis, Phoenix, 73408
Dr Gitanjali PETKAR Principal Investigator (Dermatologist), MBBS, DDV, +2304012600, g.petkar@cidp-cro.com
About this study
Official title: COMPARATIVE EVALUATION OF THE DERMATOLOGICAL TOLERANCE AND EFFICACY OF A COSMETIC SERUM VERSUS A 4% HYDROQUINONE-BASED PRODUCT IN SUBJECTS WITH MELASMA, AFTER 84 DAYS OF USE - STUDY CONDUCTED UNDER DERMATOLOGICAL SUPERVISION
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:
Read more
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
Read the detailed description
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.
- Conditions
- Healthy, Melasma (Facial Melasma), Epidermal Melasma
- Being tested
- Depigmenting Cosmetic Serum (Applied Morning and Evening)
- Keywords
- Melasma, Hyperpigmentation Skin, Pigmentation Disorders
- Medical subject headings
- Melanosis, Hyperpigmentation, Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depigmenting Cosmetic Serum (Applied Morning and Evening)Drug
Also called 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)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Depigmenting Cosmetic Serum (Applied Morning and Evening) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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)
Measured: 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 (°)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: Day 56 and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start23 Jun 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoire Dermatologique ACM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CIDP Mauritius
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071363
- Sponsor's protocol ID
- 2425CMCL065
- Status last verified
- Aug 2025
- First submitted
- 27 Jun 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE EVALUATION OF THE DERMATOLOGICAL TOLERANCE AND EFFICACY OF A COSMETIC SERUM VERSUS A 4% HYDROQUINONE-BASED PRODUCT IN SUBJECTS WITH MELASMA, AFTER 84 DAYS OF USE - STUDY CONDUCTED UNDER DERMATOLOGICAL SUPERVISION
- ClinicalTrials.gov ID
- NCT07071363
- Acronym / sponsor ID
- 2425CMCL065
- Conditions
- Healthy, Melasma (Facial Melasma), Epidermal Melasma
- Keywords
- Melasma, Hyperpigmentation Skin, Pigmentation Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Laboratoire Dermatologique ACMIndustry (pharma, biotech, devices)
- Collaborators
- CIDP Mauritius
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Depiwhite Serum + Placebo Cream | Experimental | Drug: Depigmenting Cosmetic Serum (Applied Morning and Evening)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. |
| Placebo Serum + Hydroquinone 4% Cream | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depigmenting Cosmetic Serum (Applied Morning and Evening)Also: 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)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. | Drug | Depiwhite Serum + Placebo Cream, Placebo Serum + Hydroquinone 4% Cream |
Primary outcome
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
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.
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.
6 secondary outcomes
Change in modified Melasma Area Severity Index (mMASI) at Day 56
Time frame: Day 56
Change in Individual Typology Angle (ITA°) from baseline
Time frame: Day 56 and Day 84
Change in Melasma Quality of Life Index (MELASQoL)
Time frame: Day 56 and Day 84
Subject-rated product efficacy and cosmetic acceptability
Time frame: Day 28, Day 56, and Day 84
Investigator-assessed dermatological tolerance
Time frame: Day 56 and Day 84
Subject-reported local intolerance symptoms
Time frame: Day 56 and Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Gitanjali PETKAR Principal Investigator (Dermatologist), (MBBS, DDV) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depigmenting Cosmetic Serum (Applied Morning and Evening) in people with Healthy and Melasma (Facial Melasma), run by Laboratoire Dermatologique ACM at 1 site in Mauritius.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mauritius. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Gitanjali PETKAR Principal Investigator (Dermatologist), (MBBS, DDV) (+2304012600, g.petkar@cidp-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.