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

February 19, 2024 updated by: Cosmetique Active International

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
      • Bangalore, India
        • Recruiting
        • MS Clinical Research Pvt. Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group TP: Test Product
Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year
Other: Group TP
Application full face, twice daily, in the morning and at bedtime for 4 months
Other Names:
  • Test Product
Active Comparator: Group CYS: Cysteamine 5%
Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year
Drug: Group CYS
Application short contact, of thin layer once daily at bedtime for 4 months
Other Names:
  • Cysteamine 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in mMASI scoring
Time Frame: 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).
from baseline to Day112
change in Investigator's Global Assessment (IGA)
Time Frame: 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)).
from baseline to Day112

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cosmetique Active International

Investigators

  • Principal Investigator: Mukta Sachdev, MS Clinical Research Pvt. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRP23023-depigmenting cream

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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