Comparison of minocycline extended release tablet versus minocycline tablet in patients with facial pimples
Phase 4
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Registration Number
- CTRI/2019/12/022267
- Lead Sponsor
- Government Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Subjects with inflammatory, non nodular moderate to severe facial acne vulgaris
2.Subjects between 12-18 years of age, written assent will be taken.
3.Subjects of either gender.
4.Subjects willing to give written informed consent.
Exclusion Criteria
1. Subjects with more than 2 nodules or cysts on the face,
2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
3. Female Subjects who are pregnant, nursing or planning a pregnancy during the study.
4 Subjects with known or suspected allergy to one of the investigational products.
5. Subjects with history of liver & kidney disorder.
6. Subjects on anticoagulants, antacids, iron tablets..
7. Subjects with history of autoimmune disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of Extended release minocycline versus minocycyline in moderate to severe non-nodular facial acne vulgaris. <br/ ><br>Timepoint: efficacy assessment will be done at 4th week and then at 8th week
- Secondary Outcome Measures
Name Time Method 1. To assess the safety of extended release <br/ ><br>minocycline and minocycline in moderate to severe non nodular facial acne vulgaris. <br/ ><br>2.To assess the cost effectiveness of extended release minocycline and minocycline in moderate to severe non nodular facial acne vulgaris.Timepoint: 8 weeks