A clinical trial to compare Adapalene and Benzoyl Peroxide combination local application gel to Epiduo? of Galderma Laboratories,L.P. and both these to an inactive local application gel in patients with mild to severe pimple

Phase 3

Completed

• Conditions: Health Condition 1: null- Acne Vulgaris

• Registration Number: CTRI/2011/05/001762
• Lead Sponsor: Actavis MidAtlantic LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 890

Inclusion Criteria

1.Male or nonpregnant female patients must be between the ages of 12 and 40 years old inclusive.

2.Patients who are 18 years of age or older must have provided IEC/IRB approved written informed consent. Patients between the ages of 12 to 17 years of age must have provided IEC/IRB approved written assent; this written assent must be accompanied by an IEC/IRB approved written informed consent from the patient?s legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization, if applicable.

3.Patients must have a definite clinical diagnosis of mild to severe acne vulgaris (Grade 2, Grade 3 or Grade 4 on the IGE).

4.Patients must have a minimum of 20 inflammatory lesions and a maximum of 100 and a minimum of 25 and a maximum of 100 non-inflammatory lesions (i.e., open and closed comedones) and no more than 2 nodulocystic lesions (i.e., nodules and cysts) at baseline. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Lesions involving the eyes, angles of the nose (i.e., the lines around your nostrils and under the nostrils) and scalp should be excluded from the count. Patients may have acne lesions on other areas of the body (e.g., on the back).

Exclusion Criteria

1.Female patients who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 5) will be excluded from study participation.

2.Patients who have a known hypersensitivity to benzoyl peroxide, adapalene, and other retinoids, or their excipients will be excluded from study participation.

3.Patients who have conditions that may interfere with the evaluation of acne vulgaris. Such conditions include, but are not limited to the following lesions on the face: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema.

4.Patients who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified