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

NCT06787846 | Completed

• 1 other identifier: 21028 - Serum vs HQ4%
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melasma

Keywords

Melasma; Hydroquinone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Investigator's Global Assessment (IGA)

  From baseline to3 months

• Change in Subject Global Assessment of Improvement (SGAI)

  From 1month to 3 months

• Change of Quality of life

  From 1month to 3 months

• Change of stigmatization evaluation

  From 1month to 3 months

Study Arms (2)

Group TP: Tested product

EXPERIMENTAL

Subjects (aged over 18 years) with mild to severe facial epidermal or mixed melasma

Other: Experimental: Group TP

Group HQ: Hydroquinone 4%

ACTIVE COMPARATOR

Subjects (aged over 18 years) with mild to severe facial epidermal or mixed melasma

Drug: Active Comparator: Group HQ: Hydroquinone 4%

Interventions

Experimental: Group TP OTHER

Serum : Application full face, twice daily, in the morning and at bedtime for 4 months and application Tinted sunscreen SPF 50+, twice a day

Also known as: Tested Product

Group TP: Tested product

Active Comparator: Group HQ: Hydroquinone 4% DRUG

Cream : Application all over the face once a day (at bedtime) and Tinted sunscreen SPF 50+, twice a day

Also known as: Hydroquinone

Group HQ: Hydroquinone 4%

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

CIDP

Rio de Janeiro, Brazil

Location

Related Publications (1)

• 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.

  PMID: 40586974 DERIVED

MeSH Terms

Conditions

Melanosis

Interventions

hydroquinone

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Renato Moura

  CIDP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 22, 2025
• Study Start: August 17, 2023
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

BR (1)