A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called W0265 Gel - Full Text View

Sponsor:	Stiefel, a GSK Company
Information provided by:	Stiefel, a GSK Company
ClinicalTrials.gov Identifier:	NCT00689117

Purpose

The purpose of this study is to demonstrate the safety and effectiveness of W0265 gel in subjects with acne vulgaris. The hypothesis is that W0265 is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.

Condition	Intervention	Phase
Acne Vulgaris Acne	Drug: W0265 Gel Drug: Clindamycin Gel (clindamycin ) Drug: Tretinoin Gel (tretinoin) Drug: Vehicle Gel	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of W0265 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 Tretinoin

U.S. FDA Resources

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

Primary Outcome Measures:

Co-Primary Endpoints:The absolute change in lesion counts (total, inflammatory, non-inflammatory) from baseline to week 12.; the proportion of subjects who have a minimum two grade improvement in ISGA score from baseline to week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The percent (%) change in lesion counts (total, inflammatory, non-inflammatory) from baseline to week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
The proportion of subjects who have a SGA score of 0 or 1 at week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment:	1656
Study Start Date:	April 2008
Study Completion Date:	May 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental W0265 Gel	Drug: W0265 Gel Once daily in the evening for 12 weeks
2: Active Comparator Clindamycin Gel (clindamycin)	Drug: Clindamycin Gel (clindamycin ) once daily in the evening for 12 weeks
3: Active Comparator Tretinoin Gel (tretinoin)	Drug: Tretinoin Gel (tretinoin) Once daily in the evening for 12 weeks
4: Placebo Comparator Vehicle Gel	Drug: Vehicle Gel Once daily in the evening for 12 weeks

Detailed Description:

W0265 gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female 12 years of age or older in good general health
ISGA score of 2 or greater at Baseline

Exclusion Criteria:

Any nodulo-cystic lesions at Baseline
Pregnancy or breast feeding
History or presence of regional enteritis or inflammatory bowel disease or similar symptoms.
Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start.
Use of topical anti-acne medications within the past 2 weeks.
Use of topical or systemic antibiotics on the face within the past 2 weeks.
Use of topical or systemic corticosteroids within the past 2 weeks.
Use of systemic retinoids within the past 3 months.
Use of astringents, toners and skin cleansers for less than 2 weeks prior to the start of the study.
Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
Concomitant use of mega-doses of certain vitamins, such as vitamin D (>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
Concomitant use of tanning booths or sunbathing.
Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, retinoids or excipients of the study product
A significant medical history of or are currently immunocompromised
Current drug or alcohol abuse. (Drug screening not required.)
Use of any investigational therapy within 4 weeks of enrollment.
Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689117

Show 32 Study Locations

Sponsors and Collaborators

Stiefel, a GSK Company

Investigators

Study Director:

David A. Angulo, MD

Stiefel Labortories, Inc.

More Information

No publications provided

Responsible Party:	Stiefel Laboratories, Inc. ( Jason Mann, Director, Global Clinical Operations )
Study ID Numbers:	W0265-03
Study First Received:	May 24, 2008
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00689117 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Stiefel, a GSK Company:

Acne Vulgaris
Acne

Additional relevant MeSH terms:

Anti-Infective Agents
Clindamycin
Facial Dermatoses
Skin Diseases
Clindamycin-2-phosphate
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Sebaceous Gland Diseases

Acne Vulgaris
Pharmacologic Actions
Keratolytic Agents
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Acneiform Eruptions
Therapeutic Uses
Tretinoin
Dermatologic Agents

ClinicalTrials.gov processed this record on November 27, 2009