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

Last updated: February 19, 2024
Sponsor: Cosmetique Active International
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Group TP

Group CYS

Clinical Study ID

NCT06278948
LRP23023-depigmenting cream
  • Ages 20-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Subjects with any other signs of significant irritation or skin disease
  • Subjects using oral contraceptive pills or hormonal implants as birth control measuresduring the study
  • Subjects who had a skin lightening procedure in the past 8 weeks

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Group TP
Phase:
Study Start date:
October 06, 2023
Estimated Completion Date:
June 30, 2024

Study 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 (%).

Connect with a study center

  • MS Clinical Research Pvt. Ltd

    Bangalore,
    India

    Active - Recruiting

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