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

D

Derm Research

Status and phase

Completed
Phase 4

Conditions

Acne Vulgaris

Treatments

Drug: Aczone 5% gel
Drug: Doxycycline 100mg

Study type

Interventional

Funder types

Other

Identifiers

NCT01885910
IIT-000508

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

12 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

doxy + aczone
Experimental group
Description:
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
Treatment:
Drug: Doxycycline 100mg
Drug: Aczone 5% gel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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