Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne - Full Text View

Sponsor:	Stiefel, a GSK Company
Collaborators:	Quintiles CRO RHO CRO
Information provided by:	Stiefel, a GSK Company
ClinicalTrials.gov Identifier:	NCT00776919

Purpose

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

Condition	Intervention	Phase
Acne Vulgaris	Drug: clindamycin / benzoyl peroxide gel Drug: clindamycin gel Drug: BPO gel Drug: vehicle gel	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Benzoyl peroxide

U.S. FDA Resources

Further study details as provided by Stiefel, a GSK Company:

Primary Outcome Measures:

Acne lesion counts and Investigator's Static Global Assessment (ISGA). [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Local tolerability and adverse events [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1320
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental clindamycin / benzoyl peroxide gel	Drug: clindamycin / benzoyl peroxide gel Once a day application to the face
2: Active Comparator Clindamycin gel	Drug: clindamycin gel Once a day application to the face
3: Active Comparator BPO gel	Drug: BPO gel Once a day application to the face
4: Placebo Comparator vehicle gel	Drug: vehicle gel Once a day application to the face

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 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).

Eligibility

Ages Eligible for Study:	12 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776919

Show 24 Study Locations

Sponsors and Collaborators

Stiefel, a GSK Company

Quintiles CRO

RHO CRO

Investigators

Study Director:

David A Angulo, MD

Stiefel, a GSK Company

More Information

No publications provided

Responsible Party:	Stiefel Laboratories, Inc. ( Jason Mann/Director, Global Clinical Operations )
Study ID Numbers:	W0261-301
Study First Received:	October 21, 2008
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00776919 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Stiefel, a GSK Company:

Acne
Acne Vulgaris

Additional relevant MeSH terms:

Anti-Infective Agents
Clindamycin
Facial Dermatoses
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Clindamycin-2-phosphate
Benzoyl Peroxide
Enzyme Inhibitors

Sebaceous Gland Diseases
Acne Vulgaris
Pharmacologic Actions
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Acneiform Eruptions
Therapeutic Uses
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010