Phase 4
Completed N=54
Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne
Source: ClinicalTrials.gov NCT00841776 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcomePrimary: Median Change in Total Propionibacterium Acne (P.Acne) Counts — -1.26; -0.08; -1.58; -0.67 P. acne counts
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Change in Total Propionibacterium Acne (P.Acne) Counts |
-1.26; -0.08; -1.58; -0.67; -1.65; -0.32 | — |
| SECONDARY Median Change in Clindamycin Resistant P. Acne. |
-0.30; 0; 0; 0; -0.86; 0 | — |
| SECONDARY Median Change in Erythromycin-resistant P. Acne Counts |
-0.36; 0; -0.18; 0; -0.83; 0 | — |
| SECONDARY Median Change in Total Acne Lesions |
-14; -13; -22; -14; -27; -19 | — |
| SECONDARY Median Change in Inflammatory Acne Lesion Counts |
-7; -7; -12; -7; -11; -7 | — |
| SECONDARY Median Change in Noninflammaotry Acne Counts |
-6; -6; -10; -8; -13; -12 | — |
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
Data sourced from ClinicalTrials.gov (NCT00841776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.