Clinical trial NCT01885910: Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel
Official title: Use of Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
Collaborators: name: WFH MEDICAL, LLC
First posted: 2013-06-25
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Percentage of Participants Who Remained Responders at Week 24
timeFrame: Assessed every 4 weeks, reported at Week 24
Secondary outcomes:
measure: Inflammatory and Non-inflammatory Lesion Counts
timeFrame: Every 4 weeks
measure: Percentage of Participants Who Are Responders at Week 16 and 20
timeFrame: Assessed every 4 weeks, reported at weeks 16 and 20
measure: Nodule Counts
timeFrame: every four weeks
measure: Erythema
timeFrame: every 4 weeks
measure: Dryness
timeFrame: every 4 weeks
measure: Peeling
timeFrame: every four weeks
measure: Oiliness
timeFrame: every 4 weeks
measure: Pruritis
timeFrame: every 4 weeks
measure: Burning
timeFrame: every 4 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
Study officials:
affiliation: DermResearch, PLLC
name: Leon H Kircik, MD
role: PRINCIPAL_INVESTIGATOR
References: