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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06278948
Other study ID # LRP23023-depigmenting cream
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 6, 2023
Est. completion date June 2024

Study information

Verified date February 2024
Source Cosmetique Active International
Contact Mukta Sachdev
Phone +91 8041125934
Email mukta.sachdev@msclinical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 (%).


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Group TP
Application full face, twice daily, in the morning and at bedtime for 4 months
Drug:
Group CYS
Application short contact, of thin layer once daily at bedtime for 4 months

Locations

Country Name City State
India MS Clinical Research Pvt. Ltd Bangalore

Sponsors (1)

Lead Sponsor Collaborator
Cosmetique Active International

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in mMASI scoring 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
Primary change in Investigator's Global Assessment (IGA) 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 change in Subject Global Assessment of Improvement (SGAI) The subject evaluates the change on a 6-point scale from -1 (worsened) to 4 (totally cleared). from Day28 to Day112
See also
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