Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma

Cosmetique Active

Status: Enrolling

Conditions: Melasma

Treatments: Drug: Group CYS; Other: Group TP

Study type: Interventional

Funder types: Industry

Identifiers

NCT06278948

LRP23023-depigmenting cream

Details and patient eligibility

About

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.

Full description

Melasma is a very common pigmentation disorder which significantly alters quality of life as per its high visibility on the face. The objective is to compare the efficacy and tolerability of the new depigmenting formulation that addresses the different targets of hyperpigmentation and includes an inhibitor of melanin production with a breakthrough innovative mechanism of action versus Cysteamine 5% in the acute management of melasma over 4 months.

Statistics:

Sample size calculation: 120 patients (60 per group) are necessary to reach the non-inferiority objective of the Test Product versus Cysteamine 5% on the modified Melasma Area and Severity Index (mMASI) change from Baseline at Month 4. To allow a rate of subjects excluded from analysis (drop out, lost to follow-up, major deviation) at Month 4, 140 subjects in total (70 per group) are enrolled.

Statistical analysis: Continuous data collected at each visit will be summarized using common statistical measures such as the count of values, mean, standard deviation, median minimum and maximum. For categorical data, summaries will be provided in terms of frequency counts (n) and percentages (%).

Enrollment: 140 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

Group TP: Test Product

Experimental group

Description:

Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year

Treatment:

Other: Group TP

Group CYS: Cysteamine 5%

Active Comparator group

Description:

Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year

Treatment:

Drug: Group CYS