Melasma Clinical Trial
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
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.
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 |
Country | Name | City | State |
---|---|---|---|
India | MS Clinical Research Pvt. Ltd | Bangalore |
Lead Sponsor | Collaborator |
---|---|
Cosmetique Active International |
India,
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 |
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