Status:
COMPLETED
Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel
Lead Sponsor:
Derm Research, PLLC
Collaborating Sponsors:
WFH MEDICAL, LLC
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-85 years
Phase:
PHASE4
Brief 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.
Detailed Description
This is a two-center, open-label pilot study. The study is apprised of 7 study visits: Baseline and Weeks 4, 8, 12, 16, 20 and 24. All subjects will receive Aczone 5% gel BID and doxycycline 100mg by ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01885910
Start Date
July 1 2013
End Date
July 1 2014
Last Update
February 27 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
DermResearch, PLLC
Louisville, Kentucky, United States, 40217