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Comparing the Effectiveness, Safety, and Cost of Minocycline Gel vs. Adapalene plus Benzoyl Peroxide Gel for Mild to Moderate Facial Acne, A randomized study

Comparative study of efficacy, safety and cost effectiveness of Minocycline 4 percent gel and Adapalene 0.1 percent plus Benzoyl peroxide 2.5 percent combination gel in mild to moderate facial Acne vulgaris. A prospective, randomized, open labelled parallel study. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084241
Enrollment
80
Registered
2025-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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: Participants will be advised to apply one fingertip unit (0.5 grams) of Minym Gel from Glenmark Pharmaceuticals Ltd, once daily at night for a duration of 8

Sponsors

All India Institute of Medical Sciences Nagpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender aged between 12 and 40 years, suffering from mild to moderate facial acne vulgaris, having a GAGS score less than or equal to 30, willing to give written informed consent who had not taken topical antiacne medications in last 14 days and, systemic medications in last 30 days will be included in this study

Exclusion criteria

Exclusion criteria: Patients already on topical anti-acne medication for 14 days, use of systemic therapy within last 30 days before inclusion into the study, patients with a dermatological condition of the face that could interfere with the clinical evaluations, such as sunburn, psoriasis, seborrheic dermatitis, or eczema, patients who were on oral contraceptive pills in the last 12 weeks, patients unwilling to give written informed consent, Individuals with secondary acne, such as occupational acne or drug induced acne, patients who have known hypersensitivity to adapalene, minocycline, benzoyl peroxide or any ingredient of the study drug, Pregnant or lactating women and the patients who the investigator deemed to be unsuitable for any reason will be excluded from the study

Design outcomes

Primary

MeasureTime frame
The mean reduction in GAGS score from baseline to week 8 in each treatment regimen group will be the primary outcome of the studyTimepoint: 8 weeks

Secondary

MeasureTime frame
Number of adverse events in each treatment regimen group as reported by patients or observed by investigator over the duration of 8 weeks of treatment will be secondary outcome of this studyTimepoint: 0 to 8 weeks;The Cost effectiveness ratio of each treatment regimen by calculating the Average and Incremental Cost Effectiveness Ratio by the end of 8 weeks will be a secondary outcome of this studyTimepoint: 8 weeks

Countries

India

Contacts

Public ContactDr Nishanth P

All India Institute of Medical Sciences Nagpur

nishanthgdrive@gmail.com7826872358

Outcome results

None listed

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