Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne

Stiefel

Status and phase: Completed; Phase 4

Conditions: Acne

Treatments: Drug: Ziana gel; Drug: Duac

Study type: Interventional

Funder types: Industry

Identifiers

NCT00841776

DTG0703

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Duac gel

Active Comparator group

Description:

Clindamycin and benzoyl peroxide gel

Treatment:

Drug: Duac

Ziana gel

Active Comparator group

Description:

Clindamycin and tretinoin gel

Treatment:

Drug: Ziana gel