Effectiveness and safety of a fixed dosed combination of adapalene and clindamycin in the treatment of acne vulgaris.
- Conditions
- Health Condition 1: null- Acne VulgarisHealth Condition 2: L088- Other specified local infections of the skin and subcutaneous tissue
- Registration Number
- CTRI/2018/04/013109
- Lead Sponsor
- Investigator Initiated Study
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients with acne of mild to moderate as per the Combined Acne Severity Classification.8
a.Mild acne: fewer than 20 comedones, or fewer than 15 inflammatory lesions or a total lesion count lower than 30
b.Moderate acne: 20-100 comedones, or 15-50 inflammatory lesions or a total lesion count of 30-125
c.Severe acne: more than 5 cysts, or comedone count greater than 100, or a total inflammatory count greater than 50, or a total lesion count greater than 125
2.Male and female patients aged between 18 to 30 years.
3.Subjects willing to comply with study visits and procedure
4.Patients taking certain topical and systemic treatments required to undergo 01 month washout periods before they can enter the study.
1. Patients not willing to sign consent form
2. Who have a diagnosed hormonal or endocrine cause for acne
3. Acne conglobata, acne fulminans, secondary acne, severe acne, or other dermatologic conditions requiring systemic treatment.
4. Women are to be excluded if they are pregnant, planning a pregnancy or nursing
5. Patients having any contraindication to clindamycin or adapalene
6. Men with beards are excluded if these are likely to cause interference with study assessments
7. Any significant medical condition which may interfere with the patients optimal participation in the study as per Investigators opinion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method