Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Derm Research, PLLC
• Collaborator: WFH MEDICAL, LLC
• Treatments: Dapsone; Doxycycline

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.