Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma
NCT ID: NCT06278948
Last Updated: 2024-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2023-10-06
2024-06-30
Brief Summary
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Detailed Description
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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 (%).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group TP: Test Product
Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year
Group TP
Application full face, twice daily, in the morning and at bedtime for 4 months
Group CYS: Cysteamine 5%
Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year
Group CYS
Application short contact, of thin layer once daily at bedtime for 4 months
Interventions
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Group TP
Application full face, twice daily, in the morning and at bedtime for 4 months
Group CYS
Application short contact, of thin layer once daily at bedtime for 4 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face
Exclusion Criteria
* 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
20 Years
50 Years
ALL
Yes
Sponsors
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Cosmetique Active International
INDUSTRY
Responsible Party
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Principal Investigators
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Mukta Sachdev
Role: PRINCIPAL_INVESTIGATOR
MS Clinical Research Pvt. Ltd
Locations
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MS Clinical Research Pvt. Ltd
Bangalore, , India
Countries
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Central Contacts
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Other Identifiers
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LRP23023-depigmenting cream
Identifier Type: -
Identifier Source: org_study_id
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