MelasmaNCT06787846
EFFICACY and TOLERABILITY of TESTED FORMULA VS. HYDROQUINONE 4% in the TREATMENT of FACIAL MELASMA
A study testing Experimental: Group TP and Active Comparator: Group HQ: Hydroquinone 4% in people with Melasma, run by Cosmetique Active International at 1 site in Brazil.
Trial summary
This study aims at assessing the non-inferiority of tested formula facial serum (2039125 03) versus hydroquinone 4% over 3 months for treatment and then 3 months for maintenance ofwomen subjects presenting facial melasma. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Experimental: Group TP and Active Comparator: Group HQ: Hydroquinone 4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Aug 2023to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women;
- Adults (over 18 y.o.) (preference 18-50 y.o.);
- Phototypes I to IV;
- Melasma epidermal or mixed (exclude dermal melasma);
- Ready to protect as much as possible from the sun for the duration of the study;
- Ready to avoid contraindicated products (irritants, other depigmenting agents);
- Participants demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form.
Who cannot join
- Subjects with dermal melasma (wood lamp at inclusion);
- Subjects who has already use of hydroquinone 4% in the past year;
- Subjects with stable hormonal therapy (contraceptive ou THS) for at least 6 months;
- Pregnant or breastfeeding women or pregnancy plans;
- Subjects applying irritants (such as peeling, acid..) (2 weeks wash out);
- Subjects under active treatment of melasma (including topicals or procedures) within the last 2 weeks;
Show all 18Show fewer
- Subjects using drugs that can induce melasma such as antiepileptics (1 month wash out);
- Subjects using other products claiming a depigmenting activity (1 month wash out);
- Subjects with other dermatosis of the face or known photosensitivity;
- All types of topical treatment applied to the face (wash out of 2 weeks)
- Subjects without any facial procedure planned during the course of the study
- Subjects under phototherapy (1 month wash out)
- Subjects hypersensitivity to the products of the study
- Any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction
- Subjects currently using any medication, which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
- Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics, or medication
- Participation in another clinical study
- Employee of the sponsor or the study site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION of the EFFICACY and TOLERABILITY of TESTED FORMULA VS. HYDROQUINONE 4% in the TREATMENT of FACIAL MELASMA OVER 3 MONTHS
This study aims at assessing the non-inferiority of tested formula facial serum (2039125 03) versus hydroquinone 4% over 3 months for treatment and then 3 months for maintenance ofwomen subjects presenting facial melasma.
Read the detailed description
Topical treatments are usually used first line. Among a high number of molecules claiming a depigmenting effect, hydroquinone used at various concentrations (typically 2 to 5%) is the most widely used skin depigmenting product and is considered, up to now, the gold standard when used at 4-5%.
Hydroquinone is sometimes combined in the Kligman's trio, with topical tretinoin and topical steroids, which remains the best initial treatment for melasma in terms of efficacy.
This randomized , two-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial hyperpigmentation.
This clinical trial is conducted in accordance with the protocol, the HELSINKI declaration (1964) and subsequent amendments, and/or the International Council on Harmonization (ICH) Good Clinical Practices (GCP)/ and in compliance with applicable regulatory requirements.
Statistical Analysis:
- Primary Efficacy Analysis: The primary performance endpoint is the difference between tested formula facial serum (2039125 03) versus hydroquinone 4% in mean change from baseline in modified Melasma Area Severity Index (mMASI) score at D84. A non-inferiority followed by a superiority evaluation will be assessed.
- Sensitivity analyses The same analysis will be repeated on the FAS population. Missing values (i.e. data of patients who dropped out the study or with no evaluable data) will not be imputed for this analysis.
Depending on the results of the baseline characteristics description, other sensitivity analyses could be performed by adding other relevant baseline covariables to the model.
. Safety Analysis: no statistical analysis will be performed on safety. The data are presented descriptively.
Categorical data are summarized using the number and percentage of patients in each category. Continuous data are summarized using the arithmetic mean, Standard Deviation (SD), Q1, Q3, minimum, median and maximum values.
Regarding the sample size determination, there was no formal calculation. A number of 104 patients , 52 patients in each group was considered sufficient to meet the study objective.
- Conditions
- Melasma
- Being tested
- Experimental: Group TP, Active Comparator: Group HQ: Hydroquinone 4%
- Keywords
- Melasma, Hydroquinone
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Group TPOther
Also called Tested Product
Serum : Application full face, twice daily, in the morning and at bedtime for 4 months and application Tinted sunscreen SPF 50+, twice a day
Active Comparator: Group HQ: Hydroquinone 4%Drug
Also called Hydroquinone
Cream : Application all over the face once a day (at bedtime) and Tinted sunscreen SPF 50+, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Group TP: Tested product | Experimental | Subjects (aged over 18 years) with mild to severe facial epidermal or mixed melasma Receives: Other: Experimental: Group TP |
| Group HQ: Hydroquinone 4% | Active comparator | Subjects (aged over 18 years) with mild to severe facial epidermal or mixed melasma Receives: Drug: Active Comparator: Group HQ: Hydroquinone 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mMASI scoring
The mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar and chin); area of involvement for each region (using a scale from 0 to 6): darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 4).
Measured: From baseline to 3months
Evaluation of Global Tolerance
The investigator evaluates the tolerance using a 5-point skin reaction scale (0 represent No local intolerance ; 4 represent a Very severe signs or symptoms of intolerance)
Measured: From 1month to 3 months
Secondary outcomes (4)
Change in Investigator's Global Assessment (IGA)
The investigator evaluates the severity of melasma using a 4-point scale (from 0 (cleared, almost cleared) to 3 (severe (markedly darker than the surrounding normal skin)).
Measured: From baseline to3 months
Change in Subject Global Assessment of Improvement (SGAI)
The subject evaluates the change on a 6-point scale from -1 (worsened) to 4 (totally cleared).
Measured: From 1month to 3 months
Change of Quality of life
Subjects evaluate about the impact of melasma on the quality of life. On a scale of 1 (not bothered at all) to 7 (bothered all the time), the subject's rate how they feel. MELAS Qol scores range from 7 to 70, with a higher score signifying worse quality of life.
Measured: From 1month to 3 months
Change of stigmatization evaluation
Subjects evaluate about the impact of melasma on stigmatization evaluation. On a scale of 1 (not bothered at all) to 7 (bothered all the time), the subject's rate how they feel. MELAS Qol scores range from 7 to 70, with a higher score signifying worse quality of life.
Measured: From 1month to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start17 Aug 2023
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renato Moura, Principal investigator, CIDP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787846
- Sponsor's protocol ID
- 21028 - Serum vs HQ4%
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Passeron T, Kerob D, Le Dantec G, Demessant-Flavigny AL, do Nascimento AR, Moura R, Salah S, Feiges M, Fernandez E, Alexis A. Efficacy and Tolerability of a New Facial 2-Mercaptonicotinoyl Glycine-Containing Depigmenting Serum Versus Hydroquinone 4% over 3-Month Treatment of Facial Melasma. Dermatol Ther (Heidelb). 2025 Sep;15(9):2379-2390. doi: 10.1007/s13555-025-01473-4. Epub 2025 Jun 30.
PubMed 40586974
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION of the EFFICACY and TOLERABILITY of TESTED FORMULA VS. HYDROQUINONE 4% in the TREATMENT of FACIAL MELASMA OVER 3 MONTHS
- ClinicalTrials.gov ID
- NCT06787846
- Acronym / sponsor ID
- 21028 - Serum vs HQ4%
- Conditions
- Melasma
- Keywords
- Melasma, Hydroquinone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 22 Jan 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.
This study aims at assessing the non-inferiority of tested formula facial serum (2039125 03) versus hydroquinone 4% over 3 months for treatment and then 3 months for maintenance ofwomen subjects presenting facial melasma.
Detailed description
Topical treatments are usually used first line. Among a high number of molecules claiming a depigmenting effect, hydroquinone used at various concentrations (typically 2 to 5%) is the most widely used skin depigmenting product and is considered, up to now, the gold standard when used at 4-5%.
Hydroquinone is sometimes combined in the Kligman's trio, with topical tretinoin and topical steroids, which remains the best initial treatment for melasma in terms of efficacy.
This randomized , two-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial hyperpigmentation.
This clinical trial is conducted in accordance with the protocol, the HELSINKI declaration (1964) and subsequent amendments, and/or the International Council on Harmonization (ICH) Good Clinical Practices (GCP)/ and in compliance with applicable regulatory requirements.
Statistical Analysis:
- Primary Efficacy Analysis: The primary performance endpoint is the difference between tested formula facial serum (2039125 03) versus hydroquinone 4% in mean change from baseline in modified Melasma Area Severity Index (mMASI) score at D84. A non-inferiority followed by a superiority evaluation will be assessed.
- Sensitivity analyses The same analysis will be repeated on the FAS population. Missing values (i.e. data of patients who dropped out the study or with no evaluable data) will not be imputed for this analysis.
Depending on the results of the baseline characteristics description, other sensitivity analyses could be performed by adding other relevant baseline covariables to the model.
. Safety Analysis: no statistical analysis will be performed on safety. The data are presented descriptively.
Categorical data are summarized using the number and percentage of patients in each category. Continuous data are summarized using the arithmetic mean, Standard Deviation (SD), Q1, Q3, minimum, median and maximum values.
Regarding the sample size determination, there was no formal calculation. A number of 104 patients , 52 patients in each group was considered sufficient to meet the study objective.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TP: Tested product | Experimental | Other: Experimental: Group TPSubjects (aged over 18 years) with mild to severe facial epidermal or mixed melasma |
| Group HQ: Hydroquinone 4% | Active comparator | Drug: Active Comparator: Group HQ: Hydroquinone 4%Subjects (aged over 18 years) with mild to severe facial epidermal or mixed melasma |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women;
- Adults (over 18 y.o.) (preference 18-50 y.o.);
- Phototypes I to IV;
- Melasma epidermal or mixed (exclude dermal melasma);
- Ready to protect as much as possible from the sun for the duration of the study;
Key exclusion criteria (18 listed)
- Subjects with dermal melasma (wood lamp at inclusion);
- Subjects who has already use of hydroquinone 4% in the past year;
- Subjects with stable hormonal therapy (contraceptive ou THS) for at least 6 months;
- Pregnant or breastfeeding women or pregnancy plans;
- Subjects applying irritants (such as peeling, acid..) (2 weeks wash out);
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 |
|---|---|---|
| Experimental: Group TPAlso: Tested ProductSerum : Application full face, twice daily, in the morning and at bedtime for 4 months and application Tinted sunscreen SPF 50+, twice a day | Other | Group TP: Tested product |
| Active Comparator: Group HQ: Hydroquinone 4%Also: HydroquinoneCream : Application all over the face once a day (at bedtime) and Tinted sunscreen SPF 50+, twice a day | Drug | Group HQ: Hydroquinone 4% |
Primary outcome
Change in mMASI scoring
Time frame: From baseline to 3months
The mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar and chin); area of involvement for each region (using a scale from 0 to 6): darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 4).
Evaluation of Global Tolerance
Time frame: From 1month to 3 months
The investigator evaluates the tolerance using a 5-point skin reaction scale (0 represent No local intolerance ; 4 represent a Very severe signs or symptoms of intolerance)
4 secondary outcomes
Change in Investigator's Global Assessment (IGA)
Time frame: From baseline to3 months
Change in Subject Global Assessment of Improvement (SGAI)
Time frame: From 1month to 3 months
Change of Quality of life
Time frame: From 1month to 3 months
Change of stigmatization evaluation
Time frame: From 1month to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Derived from this study: PubMed 40586974Passeron T, Kerob D, Le Dantec G, Demessant-Flavigny AL, do Nascimento AR, Moura R, Salah S, Feiges M, Fernandez E, Alexis A. Efficacy and Tolerability of a New Facial 2-Mercaptonicotinoyl Glycine-Containing Depigmenting Serum Versus Hydroquinone 4% over 3-Month Treatment of Facial Melasma. Dermatol Ther (Heidelb). 2025 Sep;15(9):2379-2390. doi: 10.1007/s13555-025-01473-4. Epub 2025 Jun 30.
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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. This study is not recruiting at the moment.
Renato Moura principal investigator
CIDP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Group TP and Active Comparator: Group HQ: Hydroquinone 4% in people with Melasma, run by Cosmetique Active International at 1 site in Brazil.
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 7 inclusion and 18 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: finished, as of the sponsor's last update on 22 Jan 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mMASI scoring (time frame: From baseline to 3months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787846, which also lists 1 linked publication.
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 22 Jan 2025.