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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

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.

Intervention(s) in this Clinical Trial

• Drug: W0265 Gel
  • Once daily in the evening for 12 weeks
• Drug: Clindamycin Gel (clindamycin )
  • once daily in the evening for 12 weeks
• Drug: Tretinoin Gel (tretinoin)
  • Once daily in the evening for 12 weeks
• Drug: Vehicle Gel
  • Once daily in the evening for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • W0265 Gel
• Active Comparator: 2
  • Clindamycin Gel (clindamycin)
• Active Comparator: 3
  • Tretinoin Gel (tretinoin)
• Placebo Comparator: 4
  • Vehicle Gel

Primary 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
    Safety Issue?: No

Secondary Measures

• The percent (%) change in lesion counts (total, inflammatory, non-inflammatory) from baseline to week 12.
  • Time Frame: Week 12
    Safety Issue?: No
• The proportion of subjects who have a SGA score of 0 or 1 at week 12.
  • Time Frame: Week 12
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Stiefel Laboratories

Overall Clinical Trial Officials and Contacts

David A. Angulo, MD Study Director Stiefel Labortories, Inc.  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00689117

Study ID Number: W0265-03

ClinicalTrials.gov Identifier: NCT00689117

Health Authority: United States: Food and Drug Administration