Clinical trial NCT00891982: A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash
Official title: A Phase 3B, Multicenter, Assessor-Blinded Study of the Tolerability of Clindamycin 1%-Tretinoin 0.025% Gel Used in Conjunction With Benzoyl Peroxide 4% Wash in Subjects With Mild to Moderate Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.


Eligibility criteria: Inclusion Criteria:

* Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions.
* Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.

Exclusion Criteria:

* Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.

Primary outcomes:
measure: Local Tolerability - Skin Dryness
timeFrame: Screening/baseline
measure: Local Tolerability - Skin Dryness
timeFrame: Week 1
measure: Local Tolerability - Skin Dryness
timeFrame: Week 2
measure: Local Tolerability - Skin Dryness
timeFrame: Week 4
measure: Local Tolerability - Skin Scaling
timeFrame: Screening/baseline
measure: Local Tolerability - Skin Scaling
timeFrame: Week 1
measure: Local Tolerability - Skin Scaling
timeFrame: Week 2
measure: Local Tolerability - Skin Scaling
timeFrame: Week 4
measure: Local Tolerability - Erythema (Redness)
timeFrame: Screening/baseline
measure: Local Tolerability - Erythema (Redness)
timeFrame: Week 1
measure: Local Tolerability - Erythema (Redness)
timeFrame: Week 2
measure: Local Tolerability - Erythema (Redness)
timeFrame: Week 4
Secondary outcomes:
measure: Subject Assessment of Burning/Stinging
timeFrame: Screening/baseline
measure: Subject Assessment of Burning/Stinging
timeFrame: Week 1
measure: Subject Assessment of Burning/Stinging
timeFrame: Week 2
measure: Subject Assessment of Burning/Stinging
timeFrame: Week 4
measure: Subject Assessment of Itching
timeFrame: Screening/Baseline
measure: Subject Assessment of Itching
timeFrame: Week 1
measure: Subject Assessment of Itching
timeFrame: Week 2
measure: Subject Assessment of Itching
timeFrame: Week 4
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Dermatology Associates Research
state: Florida
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Knoxville
country: United States
facility: The Skin Wellness Center, PC
state: Tennessee
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Draelos ZD, Potts A, Alio Saenz AB; W0265-306 Study Group. Randomized tolerability analysis of clindamycin phosphate 1.2%-tretinoin 0.025% gel used with benzoyl peroxide wash 4% for acne vulgaris. Cutis. 2010 Dec;86(6):310-8.