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

NCT ID: NCT01885910

Last Updated: 2015-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-07-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

doxy + aczone

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

Group Type: EXPERIMENTAL

Doxycycline 100mg

Intervention Type: DRUG

Doxycycline 100mg by mouth once daily

Aczone 5% gel

Intervention Type: DRUG

Aczone 5% gel twice daily

Interventions

Doxycycline 100mg

Doxycycline 100mg by mouth once daily

Intervention Type: DRUG

Aczone 5% gel

Aczone 5% gel twice daily

Intervention Type: DRUG

Other Intervention Names

Vibramycin, Oracea, Adoxa, Atridox; Dapsone

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

WFH MEDICAL, LLC

OTHER

Sponsor Role: collaborator

Derm Research, PLLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leon H Kircik, MD

Role: PRINCIPAL_INVESTIGATOR

DermResearch, PLLC

Locations

DermResearch, PLLC

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

IIT-000508

Identifier Type: -

Identifier Source: org_study_id