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

Not Applicable

Recruiting

• Conditions: Melasma
• Interventions: Drug: Group CYS; Other: Group TP

• Registration Number: NCT06278948
• Lead Sponsor: Cosmetique Active International

Brief Summary

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.

Detailed 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 (%).

Study Timeline

• Study Start: 2023-10-06
• Status Verified: 2024-02
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group CYS: Cysteamine 5%	Group CYS	Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year
Group TP: Test Product	Group TP	Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year

Primary Outcome Measures

Name	Time	Method
change in mMASI scoring	from baseline to Day112	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).
change in Investigator's Global Assessment (IGA)	from baseline to Day112	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)).

Secondary Outcome Measures

Name	Time	Method
change in Subject Global Assessment of Improvement (SGAI)	from Day28 to Day112	The subject evaluates the change on a 6-point scale from -1 (worsened) to 4 (totally cleared).

Trial Locations

Locations (1)

MS Clinical Research Pvt. Ltd; 🇮🇳 Bangalore, India