Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00776919
• Date of registration: 21/10/2008
• Prospective Registration: No
• Primary sponsor: Stiefel, a GSK Company
• Public title: Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
• Scientific title: A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris
• Date of first enrolment: October 2008
• Target sample size: 1315
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00776919
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Belize, Canada, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

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.



Age minimum: 12 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acne Vulgaris

Intervention(s)

Drug: clindamycin / benzoyl peroxide gel

Drug: clindamycin gel

Drug: vehicle gel

Drug: BPO gel

Primary Outcome(s)

Mean Change From Baseline to Week 12 in Total Lesion Counts [Time Frame: Baseline (Day 1) and Week 12]

Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts [Time Frame: Baseline (Day 1) and Week 12]

Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts [Time Frame: Baseline (Day 1) and Week 12]

Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 [Time Frame: Baseline (Day 1) and Week 12]

Secondary Outcome(s)

Mean Change From Baseline to Week 12 in Pulse Rate [Time Frame: Baseline (Day 1) and Week 12]

Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) [Time Frame: Baseline (Day 1) and Week 12]

Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure [Time Frame: Baseline (Day 1) and Week 12]

Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging [Time Frame: Baseline; Weeks 2, 4, 8, and 12]

Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12 [Time Frame: Week 12]

Mean Change From Baseline to Week 12 in Temperature [Time Frame: Baseline (Day 1) and Week 12]

Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation [Time Frame: Baseline (Day 1) through Week 12]

Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling [Time Frame: Baseline; Weeks 2, 4, 8, and 12]

Mean Duration of Study Product Use [Time Frame: Baseline (Day 1) through Week 12]

Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12 [Time Frame: Week 12]

Secondary ID(s)

114677

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline

Quintiles, Inc.

Rho, Inc.

Results

• Results available: Yes
• Date Posted: 30/01/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00776919