Phase 4
Completed N=32
Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel
Source: ClinicalTrials.gov NCT01885910 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Percentage of Participants Who Remained Responders at Week 24 — 82 percentage of particpants — p=<.0001
Summary
This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel following combination treatment with with doxycycline and Aczone 5% gel can maintain therapeutic response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Remained Responders at Week 24 |
82 | <.0001 sig |
| SECONDARY Inflammatory and Non-inflammatory Lesion Counts |
27.3; 38.3; 5.8; 10.0; 7.3; 8.3 | — |
| SECONDARY Percentage of Participants Who Are Responders at Week 16 and 20 |
78; 87 | — |
| SECONDARY Nodule Counts |
0.4; 0.1; 0.1; 0.3 | — |
| SECONDARY Erythema |
1.3; 0.7; 0.9; 1.1 | — |
| SECONDARY Dryness |
0.6; 0.3; 0.1; 0.1 | — |
| SECONDARY Peeling |
0.4; 0.1; 0.1; 0.1 | — |
| SECONDARY Oiliness |
1.6; 0.8; 0.6; 0.3 | — |
| SECONDARY Pruritis |
0.4; 0.2; 0.1; 0 | — |
| SECONDARY Burning |
0.1; 0.1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatient, male or female subjects of any race, age 12 or older. 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;
- Facial acne vulgaris characterized by the following:
IGA Score >3 10-50 facial inflammatory lesions (papules,pustules) 10-100 facial non-inflammatory lesions (open/closed comedones)
- Able to understand and comply with the requirements of the study and sign Informed Consent/HIPAA Authorization forms
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/sensitivity to any component of the test treatment (Section 5.2), lincomycin, tetracyclines, or sulfites.
- Subjects who have not complied with the proper wash-out periods for prohibited medications/procedures (Supplement 1)>
- History of clinically significant anemia or hemolysis.
- History of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis).
- Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
- Evidence of recent alcohol or drug abuse
- Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study
- History of poor cooperation, non-compliance with medical treatment or unreliability
- Participation in an investigational drug study within 30 days of the baseline visit.
Data sourced from ClinicalTrials.gov (NCT01885910). 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.