EFFICACY and TOLERABILITY of TESTED FORMULA VS. HYDROQUINONE 4% in the TREATMENT of FACIAL MELASMA

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.

Study Overview

• Status: Completed
• Conditions: Melasma
• Intervention / Treatment: Other: Experimental: Group TP; Drug: Active Comparator: Group HQ: Hydroquinone 4%

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil
    • CIDP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Women;
2. Adults (over 18 y.o.) (preference 18-50 y.o.);
3. Phototypes I to IV;
4. Melasma epidermal or mixed (exclude dermal melasma);
5. Ready to protect as much as possible from the sun for the duration of the study;
6. Ready to avoid contraindicated products (irritants, other depigmenting agents);
7. 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.

Exclusion criteria

1. Subjects with dermal melasma (wood lamp at inclusion);
2. Subjects who has already use of hydroquinone 4% in the past year;
3. Subjects with stable hormonal therapy (contraceptive ou THS) for at least 6 months;
4. Pregnant or breastfeeding women or pregnancy plans;
5. Subjects applying irritants (such as peeling, acid..) (2 weeks wash out);
6. Subjects under active treatment of melasma (including topicals or procedures) within the last 2 weeks;
7. Subjects using drugs that can induce melasma such as antiepileptics (1 month wash out);
8. Subjects using other products claiming a depigmenting activity (1 month wash out);
9. Subjects with other dermatosis of the face or known photosensitivity;
10. All types of topical treatment applied to the face (wash out of 2 weeks)
11. Subjects without any facial procedure planned during the course of the study
12. Subjects under phototherapy (1 month wash out)
13. Subjects hypersensitivity to the products of the study
14. 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
15. 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.
16. Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics, or medication
17. Participation in another clinical study
18. Employee of the sponsor or the study site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group TP: Tested product; Subjects (aged over 18 years) with mild to severe facial epidermal or mixed melasma	Other: Experimental: Group TP; Serum : Application full face, twice daily, in the morning and at bedtime for 4 months and application Tinted sunscreen SPF 50+, twice a day; Other Names: Tested Product
Active Comparator: Group HQ: Hydroquinone 4%; Subjects (aged over 18 years) with mild to severe facial epidermal or mixed melasma	Drug: Active Comparator: Group HQ: Hydroquinone 4%; Cream : Application all over the face once a day (at bedtime) and Tinted sunscreen SPF 50+, twice a day; Other Names: Hydroquinone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)	From 1month to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)).	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).	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.	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.	From 1month to 3 months

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Principal Investigator: Renato Moura, CIDP

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Actual): March 12, 2024
• Study Completion (Actual): March 12, 2024

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Melasma; Hydroquinone
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation; Melanosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antioxidants; Protective Agents; Radiation-Protective Agents; Hydroquinone
• Other Study ID Numbers: 21028 - Serum vs HQ4%

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No