Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

Stiefel

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: clindamycin gel; Drug: BPO gel; Drug: vehicle gel; Drug: clindamycin / benzoyl peroxide gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00776919

114677

Details and patient eligibility

About

This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris

Full description

A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).

Enrollment: 1,315 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be 12 to 45 years of age, inclusive, and in good general health.
• Clinical diagnosis of acne vulgaris
• Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
• Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
• Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.

Exclusion criteria

• Are pregnant or breast-feeding.
• Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes.
• Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks.
• Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
• Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks.
• Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
• Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks.
• Used abradents or facial procedures, within the past 2 weeks.
• Use medications that may exacerbate acne.
• Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product.
• Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,315 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

clindamycin / benzoyl peroxide gel

Treatment:

Drug: clindamycin / benzoyl peroxide gel

2

Active Comparator group

Description:

Clindamycin gel

Treatment:

Drug: clindamycin gel

3

Active Comparator group

Description:

BPO gel

Treatment:

Drug: BPO gel

4

Placebo Comparator group

Description:

vehicle gel

Treatment:

Drug: vehicle gel