Comparing Minocycline Gel with Clindamycin Gel in combination with benzoyl peroxide gel in patients of moderate to severe Acne Vulgaris.

To compare the efficacy and safety of Topical Minocycline 4percent Gel versus Topical Clindamycin 1percent Gel in combination with benzoyl peroxide 2.5percent gel in patients of moderate to severe Acne Vulgaris. A Randomized active controlled open label study. - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091446

Enrollment

120

Registered

2025-07-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Interventions

Intervention1: Topical Minocycline 4% Gel: topical application of minocycline 4% gel mixed with 1:1 ratio with benzoyl peroxide 2.5% gel will be applied over acne lesions once daily in patients of mod

Eligibility

Inclusion criteria

Inclusion criteria: Male or female individuals age 9 years and above. Patients having acne vulgaris of moderate-to-severe facial acne, as defined by an Investigator 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 comedone) Providing signed consent forms after understanding the written contents outlining the requirements of participating in the study.

Exclusion criteria

Exclusion criteria: Female subjects who are pregnant, lactating, or planning to become pregnant. Use of oral retinoids or corticosteroids within 12 weeks Use of topical retinoids, topical anti-inflammatory drugs and corticosteroids, oral antibiotics, or other systemic acne treatment within 4 weeks Patients with concomitant other skin diseases like psoriasis or urticaria.

Design outcomes

Primary

Measure	Time frame
A.Primary objective 1.The number of patients who achieved IGA-assessed treatment success in each group, i.e IGA score of 0 or 1(description of clear or almost clear) plus at least a 2-grade improvement from baseline. 2.To evaluate the change in absolute count of inflammatory and non-inflammatory lesions from baseline to the end of the study. Timepoint: 3 weekly till 12 weeks	—

Secondary

Measure	Time frame
B. Secondary objective 1. To compare the IGA score and absolute inflammatory and non-inflammatory lesions between the two groups A and B in each visit. 2. The safety will be assessed by treatment associated adverse events leading to discontinuation of the treatment. 3. The acne quality of life will be assessed at baseline and week 12 in each group Timepoint: 3 weekly till 12 weeks	—

Countries

India

Contacts

Public ContactDr Yashdeep Singh Pathania

AIIMS Rajkot

yashdeepsinghpathania@gmail.com8894480089

Outcome results

None listed

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