Clinical Evaluation of Efficacy & Safety of DRF/AY/5003 in comparison with marketed drug in Acne
Not Applicable
Completed
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Registration Number
- CTRI/2018/03/012727
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 86
Inclusion Criteria
1 Subjects of either sex in the age group of 16-30 yrs mild to moderate acne
Vulgaris
2 Subjects who signed informed consent form.
3 Subjects with ability to comply with all study requirements.
4 Subjects free of Diabetes and any other clinically significant diseases .
5 Subjects with normal Liver Function Tests and Renal Function Tests
Exclusion Criteria
1 Subjects with severe acne vulgaris who require anti-infective therapies.
2 Subjects suffering from acne congloblata, endocrinal and other systemic
disorders.
3 Subjects with a lot of facial hair.
4 Pregnant or lactating mothers.
5 Subjects with involvement in any concurrent study, the nature of which may
affect the parameters being investigated in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of DRF/AY/5003 in comparison with Safi, in relieving acne, hyper-pigmentation, dark circle & chronic idiopathic urticariaTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method To assess the efficacy of DRF/AY/5003 in comparison with Safi, in relieving acne, hyper-pigmentation, dark circle & chronic idiopathic urticariaTimepoint: 12 weeks