A clinical trial to Evaluate Efficacy and Safety of AG Arbutin Cream in Skin Lightening (Melanin Reduction) In Healthy Subjects.
- Registration Number
- CTRI/2009/091/000731
- Lead Sponsor
- Piramal Life Sciences Limited Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1.Healthy male and female subjects (based on medical history and general examination) within 18 ? 55 years of age
2.Healthy subjects with no prior history of skin disease or skin related problems in past six months
3.Subjects willing to give written informed consent and willing to follow up regularly for entire duration of the study
1.Subjects who are on any medication for skin disorder or applying any topical
medication (including cosmetic) to left forearm during the duration of study.
2.Pregnant and lactating females
3.Subjects receiving steroids, retinoids, non-steroidal anti-inflammatory drugs or
any other drugs causing hyperpigmentation or used for the treatment of hyperpigmentation (Refer to Appendix A: Drugs causing hyperpigmentation & Drugs used for the treatment of hyperpigmentation)
4.Subject who has participated in any clinical trial in the past 4 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Melanin assessmentTimepoint: Baseline, Week 2± 3 days, Wk 4± 3 days;Melanin assessmentTimepoint: Baseline, Week 2± 3 days, Wk 4± 3 days
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil