Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel
Information source: Derm Research, PLLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Doxycycline 100mg (Drug); Aczone 5% gel (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Derm Research, PLLC Official(s) and/or principal investigator(s): Leon H Kircik, MD, Principal Investigator, Affiliation: DermResearch, PLLC
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.
Clinical Details
Official title: Use of Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel Treatment
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants Who Remained Responders at Week 24
Secondary outcome: Inflammatory and Non-inflammatory Lesion CountsPercentage of Participants Who Are Responders at Week 16 and 20 Nodule Counts Erythema Dryness Peeling Oiliness Pruritis Burning
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 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.
Eligibility
Minimum age: 12 Years.
Maximum age: 85 Years.
Gender(s): Both.
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.
Locations and Contacts
DermResearch, PLLC, Louisville, Kentucky 40217, United States
Additional Information
Starting date: July 2013
Last updated: February 26, 2015
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