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

Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:12 - 85
Start Date:July 2013
Contact:Maureen McAllister, MSN

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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.

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

- 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

- 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.
We found this trial at
Louisville, Kentucky 40217
Louisville, KY
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