GLK-1403

About this trial

Last updated 8 years ago

Study ID

GLK-1403

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

12 to 40 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 10 years ago

This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.

Inclusion Criteria

1. Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.

2. Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.

Exclusion Criteria

1. Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.

2. Subject has active cystic acne.

3. Subject has acne conglobata.

4. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.