A clinical trial to study the effects of adapalene, benzoyl peroxide, and benzoyl peroxide-clindamycin combination in patients having pimples.

Phase 4

Recruiting

• Conditions: Mild to Moderate Acne vulgaris

• Registration Number: CTRI/2012/11/003127
• Lead Sponsor: Peoples college of medical sciences

Brief Summary

The present study is a randomized, open label, active controlled, parallel group trial comparing the efficacy and safety of Adapalene 0.1% , Benzoyl peroxide 2.5%, and  Benzoyl peroxide 2.5% -Clindamycin 1% combination daily at bed time for 3 months in 150 patients of acne vulgaris. The study will be conducted in Peoples college of medical sciences and research center, Bhopal, India. The primary outcome measures are acne severity index and total acne lesion count.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-15
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Healthy males, and non-pregnant females, aged 12-30 years with a clinical diagnosis of mild-moderate acne vulgaris.
• Presence of Non-inflammatory lesions (comedones).
• Presence of mild to moderate inflammatory lesions like papules and pustules (Grades 1 and 2).

Exclusion Criteria

• Acne patients with ages below 12years, or above 30 years.
• Pregnant and nursing females.
• Presence of severe inflammatory lesions of acne like nodulo-cystic lesions (Grades 3 and 4).
• Presence of any other skin condition that would interfere with the diagnosis and assessment of acne vulgaris, (eg-on the face-rosaceae, dermatitis).
• Excessive facial hair (eg-beard) that would interfere with diagnosis or assessment of acne vulgaris.
• History of hypersensitivity or allergy to these drugs.
• Use of any other drug for the treatment of acne vulgaris within 2 months.
• Patients on hormonal treatment.
• Patient on drugs causing acne as a side effect.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acne severity index	Acne severity index and | Total acne lesion count will be assessed after 2 4 6 8 10 12 weeks.
Total acne lesion count	Acne severity index and | Total acne lesion count will be assessed after 2 4 6 8 10 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Acne severity index	Total acne lesion count

Trial Locations

Locations (1)

department of dermatology, PCMS; 🇮🇳 Bhopal, MADHYA PRADESH, India

department of dermatology, PCMS

🇮🇳Bhopal, MADHYA PRADESH, India

Dr Hanmant Amane

Principal investigator

8717955345

drhsamane25@gmail.com