Clinical trial NCT06278948: Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melasma
Keywords: facial epidermal melasma
MASI
Cysteamine 5%
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (%).

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

Primary outcomes:
measure: change in mMASI scoring
timeFrame: from baseline to Day112
measure: change in Investigator's Global Assessment (IGA)
timeFrame: from baseline to Day112
Secondary outcomes:
measure: change in Subject Global Assessment of Improvement (SGAI)
timeFrame: from Day28 to Day112
Other outcomes:
Locations:
city: Bangalore
country: India
facility: MS Clinical Research Pvt. Ltd
Study officials:
affiliation: MS Clinical Research Pvt. Ltd
name: Mukta Sachdev
role: PRINCIPAL_INVESTIGATOR
References: