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

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Placebo; Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%; Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02465632

GLK-1403

Details and patient eligibility

About

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.

Enrollment: 1,100 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,100 participants in 3 patient groups, including a placebo group

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

Experimental group

Description:

apply a thin layer of gel to the face

Treatment:

Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%

Active Comparator group

Description:

apply a thin layer of the gel to the face

Treatment:

Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%

Placebo topical gel

Placebo Comparator group

Description:

apply a thin layer of the gel to the face

Treatment:

Drug: Placebo