Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

Acne Vulgaris Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713609
• Other study ID #: 114570
• Secondary ID: W0259-201
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2008
• Last updated: February 23, 2012
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: February 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.

You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Description:

The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.

Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

Inclusion Criteria:

• Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.

• Subjects must have acne on their face.

• Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit.

• Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.

• Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements).

• Subjects must be able to complete the study and to comply with study instructions.

Exclusion Criteria:

• Subjects who are pregnant, trying to become pregnant, or breast-feeding.

• Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination

• History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products

• Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months.

• Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study.

• Other exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Benzoyl peroxide/clindamycin gel + tazarotene cream
clindamycin phosphate, benzoyl peroxide,and/or tazarotene cream applied topically once a day for 12 weeks
• Benzoyl peroxide/clindamycin gel + vehicle cream
clindamycin phosphate, benzoyl peroxide, vehicle cream applied topically once a day for 12 weeks
• Benzoyl peroxide gel + tazarotene cream
benzoyl peroxide, tazarotene cream applied topically once a day for 12 weeks
• Clindamycin gel + tazarotene cream
clindamycin gel and tazarotene cream applied topically once a day for 12 weeks
• Vehicle gel+ tazarotene cream
Vehicle gel and tazarotene cream applied topically once a day for 12 weeks
• Vehicle gel + vehicle cream
Vehicle gel and vehicle cream applied topically once a day for 12 weeks

Locations

Country	Name	City	State
United States	Boulder Medical Center, P.C.	Boulder	Colorado
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina
United States	Dermatology Associates Research	Coral Gables	Florida
United States	Dermatology Treatment & Research Center	Dallas	Texas
United States	Center for Dermatology Cosmetic and Laser Surgery	Fremont	California
United States	Rivergate Dermatology & Skin Care Center	Goodlettsville	Tennessee
United States	MS Hershey Medical Center	Hershey	Pennsylvania
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Suzanne Bruce and Associates, PA	Houston	Texas
United States	The Skin Wellness Center, PC	Knoxville	Tennessee
United States	Dermatology Research of Arkansas	Little Rock	Arkansas
United States	Callender Center for Clinical Research	Mitchellville	Maryland
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Center for Dermatology and Laser Surgery	Sacramento	California
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Grekin Skin Institute	Warren	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Stiefel, a GSK Company	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absolute change in lesion counts (total, inflammatory, noninflammatory) from baseline to week 12. The proportion of subjects who have a minimum 2-grade improvement in ISGA score from baseline to week 12.		12 weeks	No
Secondary	The percent (%) change in lesion counts (total, inflammatory, noninflammatory) from baseline to week 12. The proportion of subjects who have an ISGA score of 0 or 1 at week 12.		12 weeks	No