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


Derm Research

Status and phase

Phase 4


Acne Vulgaris


Drug: Aczone 5% gel
Drug: Doxycycline 100mg

Study type


Funder types




Details and patient eligibility


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.


32 patients




12 to 85 years old


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




Interventional model

Single Group Assignment


None (Open label)

32 participants in 1 patient group

doxy + aczone
Experimental group
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
Drug: Doxycycline 100mg
Drug: Aczone 5% gel

Trial contacts and locations



Data sourced from

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