Comparison of Minocycline with Clindamycin for moderate to severe Acne

Phase 4

Conditions: Health Condition 1: L700- Acne vulgaris

Registration Number: CTRI/2023/06/053419

Lead Sponsor: Dr Sujaya S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Participants with moderate-to-severe facial acne, as defined by the Investigatorâ??s Global Assessment (IGA) score of 3 or 4 and lesion counts of 20 to 50 inflammatory lesions (papules, pustules, and nodules), 25 to 100 noninflammatory lesions (open and closed comedones), and no more than 2 nodules.

2.Either gender (Male or female).

3. Age 9 years or older.

4. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Participants who are pregnant, lactating, or planning to conceive during the study.

2. Use of oral retinoids or corticosteroids within 12 weeks before randomization, as well as the use of topical retinoids, topical anti-inflammatory drugs and corticosteroids, oral antibiotics, or other systemic acne treatment within 4 weeks before the study.

3. Any facial skin conditions that would interfere with clinical evaluations, including acne conglobate, acne fulminans, or secondary acne (chloracne or drug-induced acne).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The coprimary end points are the absolute change in inflammatory lesion counts from baseline and the rates of IGA-assessed treatment success, which is defined as an IGA score of 0 or 1 (description of clear or almost clear) plus at least a 2-grade improvement from baseline. <br/ ><br> <br/ ><br>2. Photographic evaluations by the Dermatologist. <br/ ><br> <br/ ><br>3. The absolute change from baseline in noninflammatory lesion count <br/ ><br> <br/ ><br>4. The absolute change from baseline in inflammatory lesion count and the proportion of participants with treatment success according to IGA score <br/ ><br> <br/ ><br>5. Treatment-emergent adverse events (TEAEs) and Application Site tolerability.Timepoint: Week 12

Secondary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index (DLQI) Questionnaire.Timepoint: Week 0, 12 and 24;Subject satisfaction of SKINDEX 16 QuestionnaireTimepoint: Week 0, 12 and 24