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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


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 Counts

Percentage of Participants Who Are Responders at Week 16 and 20

Nodule Counts







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.


Minimum age: 12 Years. Maximum age: 85 Years. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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