Comparing a new treatment for facial melasma to Cysteamine 5%
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
NA · Cosmetique Active International · NCT06278948
This study is testing a new treatment for facial melasma to see if it works as well as Cysteamine 5% for people struggling with this skin condition.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | All |
| Sponsor | Cosmetique Active International (industry) |
| Locations | 1 site (Bangalore) |
| Trial ID | NCT06278948 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the efficacy and tolerability of a new depigmenting formulation against Cysteamine 5% in treating facial epidermal melasma over a 4-month period. Conducted at a single center, the study involves 140 participants who will be randomly assigned to receive either the new treatment or Cysteamine 5%. The primary outcome will be assessed using the modified Melasma Area and Severity Index (mMASI) to determine non-inferiority between the two treatments. The study aims to address the high visibility and impact of melasma on quality of life.
Who should consider this trial
Good fit: Ideal candidates are individuals with facial epidermal melasma who do not have other active skin conditions.
Not a fit: Patients with mixed or dermal melasma or those who have undergone recent skin lightening procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for managing facial melasma, improving patients' quality of life.
How similar studies have performed: While there have been studies on treatments for melasma, this specific approach using the new formulation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bangalore
- MS Clinical Research Pvt. Ltd — Bangalore, India (RECRUITING)
Study contacts
- Principal investigator: Mukta Sachdev — MS Clinical Research Pvt. Ltd
- Study coordinator: Mukta Sachdev
- Email: mukta.sachdev@msclinical.com
- Phone: +91 8041125934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Melasma, facial epidermal melasma, MASI, Cysteamine 5%