A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne - Full Text View

Sponsor:	Stiefel, a GSK Company
Information provided by:	Stiefel, a GSK Company
ClinicalTrials.gov Identifier:	NCT00964223

Purpose

Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Condition	Intervention	Phase
Acne Vulgaris	Drug: clindamycin and benzoyl peroxide gel (Duac® Topical Gel) Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Single-blind, Randomized, Comparative Split-face Study Evaluating the Tolerability of Clindamycin and Benzoyl Peroxide Gel to Benzoyl Peroxide/Adapalene Gel in the Treatment of 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 Adapalene

U.S. FDA Resources

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

Primary Outcome Measures:

To compare the tolerability of clindamycin and benzoyl peroxide gel to benzoyl peroxide/adapalene gel in the treatment of facial acne during the first 2 weeks of treatment. [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate efficacy, tolerability, safety and subject satisfaction of clindamycin and benzoyl peroxide gel in the treatment of acne vulgaris. To evaluate the influence of acne on subjects' quality of life. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	July 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Drug: clindamycin and benzoyl peroxide gel (Duac® Topical Gel) Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin gel and benzoyl peroxide to the entire face for an additional 6 weeks
2: Active Comparator Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel to the entire face for an additional 6 weeks.	Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel) Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Arms

Assigned Interventions

1: Active Comparator

Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Drug: clindamycin and benzoyl peroxide gel (Duac® Topical Gel)

Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin gel and benzoyl peroxide to the entire face for an additional 6 weeks

2: Active Comparator

Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel to the entire face for an additional 6 weeks.

Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)

Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Detailed Description:

Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3 subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Blinding This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation (ie, left vs. right side application). During the first 2 weeks, the investigator will be unaware of which study product is being used on either side of the face. Subjects and study-center staff will be instructed not to reveal study treatment allocation to the investigator. Subjects will be instructed not to use study product in the presence of the investigator.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris.
Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.

Exclusion Criteria:

Female subjects who are pregnant, trying to become pregnant or breastfeeding.
Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris.
Facial hair that may obscure the accurate assessment of acne grade.
History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively.
Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
Use of systemic retinoids within the past 6 months.
Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
Use of topical anti-acne medications within the past 2 weeks.
Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964223

Locations

United States, Maryland
Aesthetics, Skin Care & Dermasurgery	Recruiting
Rockville, Maryland, United States, 20850
Contact: Susan Collich 301-610-0663 scollich@comcast.net
Principal Investigator: Lawrence Green, MD
United States, Michigan
Grekin Skin Institute	Recruiting
Warren, Michigan, United States, 48088
Contact: Jennifer A Meitzner, MD 586-759-5525
Principal Investigator: Steven K Grekin, DO

Sponsors and Collaborators

Stiefel, a GSK Company

Investigators

Study Director:

Lou Barbato, MD

Stiefel, a GSK Company

More Information

No publications provided

Responsible Party:	Stiefel, a GSK Company ( Jason Mann/Director, Global Clinical Operation )
Study ID Numbers:	C0000-410
Study First Received:	August 20, 2009
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00964223 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Stiefel, a GSK Company:

Acne vulgaris

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Clindamycin
Facial Dermatoses
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Benzoyl Peroxide
Adapalene
Sebaceous Gland Diseases
Acne Vulgaris
Anti-Bacterial Agents
Acneiform Eruptions
Sensory System Agents

Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Dermatologic Agents
Clindamycin-2-phosphate
Skin Diseases
Enzyme Inhibitors
Pharmacologic Actions
Protein Synthesis Inhibitors
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on March 18, 2010