Status:
COMPLETED
Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
Rho, Inc.
Quintiles, Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-45 years
Phase:
PHASE3
Brief Summary
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
Detailed 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 par...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
1315 Patients enrolled
Trial Details
Trial ID
NCT00776919
Start Date
October 1 2008
End Date
September 1 2009
Last Update
November 23 2016
Active Locations (24)
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1
Rady Children's Hospital San Diego, Div. of Pediatric & Adolescents Dermatology
San Diego, California, United States, 92123
2
The Laser Institute for Dermatology
Santa Monica, California, United States, 90404
3
Cherry Creek Research, Inc.
Denver, Colorado, United States, 80209
4
Skin Care Research, Inc.
Boca Raton, Florida, United States, 33486