Comparison of Minocycline with Clindamycin for moderate to severe Acne

Comparison of Topical Minocycline 4% Gel and Topical Clindamycin 1% Gel in the Treatment of Moderate to Severe Acne Vulgaris: An open label, Randomized Controlled Trial - ToMAc-RC

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053419

Enrollment

200

Registered

2023-06-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: Topical Minocycline 4% Gel: Dose: 4% Frequency: Once daily 1 hour before bedtime. Duration: 12 Weeks Route of Administration: Topical Control Intervention1: Topical Clindamycin 1% Gel:

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
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. 2. Photographic evaluations by the Dermatologist. 3. The absolute change from baseline in noninflammatory lesion count 4. The absolute change from baseline in inflammatory lesion count and the proportion of participants with treatment success according to IGA score 5. Treatment-emergent adverse events (TEAEs) and Application Site tolerability.Timepoint: Week 12	—

Measure

Time frame

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. 2. Photographic evaluations by the Dermatologist. 3. The absolute change from baseline in noninflammatory lesion count 4. The absolute change from baseline in inflammatory lesion count and the proportion of participants with treatment success according to IGA score 5. Treatment-emergent adverse events (TEAEs) and Application Site tolerability.Timepoint: Week 12

—

Secondary

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

Countries

India

Contacts

Public ContactGirish B S

Consultant Dermatologist

sujayasn@gmail.com9886020078

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026