Clinical trial NCT00841776: Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne
Official title: Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Keywords: Acne Vulgaris
Acne
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-02-11
Enrollment: 54
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.

Detailed description: To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and tolerability will be assessed.

Eligibility criteria: Inclusion Criteria:

* Outpatient at least 12 years of age. 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.
* Mild to moderate facial acne vulgaris
* Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

Exclusion Criteria:

* Female subjects who are pregnant (positive urine pregnancy test), breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
* Allergy or sensitivity to any component of the test medication
* Known hypersensitivity to to any component of the investigational formulations
* Known history of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis
* Beards or sideburns
* Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
* Evidence of recent alcohol or drug abuse
* Participation in an investigational drug study within 30 days of the baseline visit

Primary outcomes:
measure: Median Change in Total Propionibacterium Acne (P.Acne) Counts
timeFrame: Baseline, Weeks 2, 4, 8, 12, & 16
Secondary outcomes:
measure: Median Change in Clindamycin Resistant P. Acne.
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16
measure: Median Change in Erythromycin-resistant P. Acne Counts
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Median Change in Total Acne Lesions
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Median Change in Inflammatory Acne Lesion Counts
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Median Change in Noninflammaotry Acne Counts
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Dermatology Specialists, PSC
state: Kentucky
city: Mason
country: United States
facility: Skin We Care Dermatology
state: Ohio
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Jackson JM, Fu JJ, Almekinder JL. A randomized, investigator-blinded trial to assess the antimicrobial efficacy of a benzoyl peroxide 5%/ clindamycin phosphate 1% gel compared with a clindamycin phosphate 1.2%/tretinoin 0.025% gel in the topical treatment of acne vulgaris. J Drugs Dermatol. 2010 Feb;9(2):131-6.