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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Doxycycline 100mg
* Drug: Aczone 5% gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: doxy + aczone<br>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 | Drug: Doxycycline 100mg<br>* Doxycycline 100mg by mouth once daily<br>* Other names: Vibramycin, Oracea, Adoxa, Atridox;Drug: Aczone 5% gel<br>* Aczone 5% gel twice daily<br>* Other names: Dapsone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Remained Responders at Week 24 | At week 12 responder had an IGA <3 on a 6-point scale ranging from 0 (clear) to 5 (very severe) and at Week 24 this response was maintained | Assessed every 4 weeks, reported at Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory and Non-inflammatory Lesion Counts |  | Every 4 weeks | 
| Percentage of Participants Who Are Responders at Week 16 and 20 | Responders is the percentage of participants who have an IGA <3 at Week 16 and 20 | Assessed every 4 weeks, reported at weeks 16 and 20 | 
| Nodule Counts | number of nodules counted | every four weeks | 
| Erythema | the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema | every 4 weeks | 
| Dryness | the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness | every 4 weeks | 
| Peeling | the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling | every four weeks | 
| Oiliness | the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness | every 4 weeks | 
| Pruritis | the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis | every 4 weeks | 
| Burning | the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning | every 4 weeks |