Clinical trial

Randomized Controlled Investigator Blinded Comparative Study of the Efficacy and Tolerability of Test Product Versus Cysteamine 5% in the Treatment of Facial Epidermal Melasma Over 4 Months

Name

LRP23023-depigmenting cream

Description

This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma.

Trial arms

Trial start

2023-10-06

Estimated PCD

2024-06-01

Trial end

2024-06-01

Status

Recruiting

Treatment

Group TP

Application full face, twice daily, in the morning and at bedtime for 4 months

Arms:

Group TP: Test Product

Other names:

Test Product

Group CYS

Application short contact, of thin layer once daily at bedtime for 4 months

Arms:

Group CYS: Cysteamine 5%

Other names:

Cysteamine 5%

Size

140

Primary endpoint

change in mMASI scoring

from baseline to Day112

change in Investigator's Global Assessment (IGA)

from baseline to Day112

Eligibility criteria

Inclusion Criteria: * Facial epidermal melasma (exclude mixed and dermal melasma) * Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face Exclusion Criteria: * Subjects with any other signs of significant irritation or skin disease * Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study * Subjects who had a skin lightening procedure in the past 8 weeks

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

Updated at

2024-02-26

1 organization

1 product

1 indication

Organization

Cosmetique Active International

Product

Group CYS

Indication

Melasma