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

Derm Research

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: Aczone 5% gel; Drug: Doxycycline 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01885910

IIT-000508

Details and patient eligibility

About

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.

Full 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 mouth once daily at Baseline. Those subjects achieving treatment response (i.e., IGA of 0, 1 or 2) at Week 12 will continue treatment with Aczone 5% gel BID at Week 12. Subjects not achieving treatment response will discontinue study participation.

Enrollment: 32 patients

Sex: All

Ages: 12 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

doxy + aczone

Experimental group

Description:

Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily and those who improve significantly are continued on Aczone gel alone to see if it can maintain therapeutic response

Treatment:

Drug: Doxycycline 100mg

Drug: Aczone 5% gel