Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel
Completed · Phase 4
Conditions studied: Acne Vulgaris
In brief
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.
Key facts
- Study ID
- NCT01885910
- Run by
- Derm Research, PLLC
- People needed
- 32
- Starts
- 2013-07-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2015-02-27
Who can join
Age: 12 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- DermResearch, PLLC — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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