Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

Study Overview
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Brief Summary
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The primary objective is to evaluate the clinical efficacy of azithromycin microspheres treatment in outpatients with moderate to severe inflammatory acne compared with first line treatment minocycline after 8 weeks of therapy

Detailed Description
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The study prematurely discontinued on the February 1, 2008 due to slow enrollment.It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Official Title
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A Phase III, Multicenter, Randomized, Double Blind-Double Dummy Study, To Evaluate Efficacy And Safety Of Treatment With Azithromycin, Microspheres, Oral Powder For Suspension, 2 G, In One Administration A Week, For 8 Weeks, Compared With Treatment With Minocycline Capsules, 100 Mg Die For 8 Weeks, In Outpatients With Moderate To Severe Inflammatory Acne.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Azithromycin microspheres
* Drug: minocycline-placebo capsules
* Drug: Azithromycin microspheres-placebo
* Drug: Minocycline capsules,


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female, > 16 years of age, with diagnosis of acne papulo-pustular, moderate (19-30 GAGS score) to severe (31-33 GAGS score) Exclusion Criteria: pregnancy, gastrointestinal and endocrinological disease, specific systemic disease, hormonal contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group A<br> | Drug: Azithromycin microspheres<br>* Azithromycin microspheres, powder for oral suspension, 2 g a week, in unique administration PO, repeated weekly for 8 weeks and minocycline-placebo capsules daily for 8 weeks plus minocycline placebo<br>Drug: minocycline-placebo capsules<br>* minocycline-placebo capsules daily for 8 weeks plus minocycline placebo<br>|
| Experimental: Treatment Group B<br> | Drug: Azithromycin microspheres-placebo<br>* Minocycline capsules, PO, 100 mg daily for 8 weeks and Azithromycin microspheres-placebo once a week for 8 weeks plus azithromycin placebo.<br>Drug: Minocycline capsules,<br>* Capsules, PO, 100 mg daily for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score | GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline. | Baseline, Week 8 End of Treatment (EOT) | 
| Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population | GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline. | Baseline, Week 8 EOT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Global Acne Grading System (GAGS) Score | GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi. Global score factored based on summing of local scores. Change: mean at observation minus baseline. | Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT | 
| Improvement of Global Acne Grading System (GAGS) Score | Number of subjects by improvement category of GAGS score: Best improvement = reduction of GAGS score >75% (pre-post evaluation); Good improvement = reduction score > 50 - 75%; Moderate improvement : reduction score > 25 - 50%; Light improvement : reduction score > 0 - 25%; No change = reduction score = 0%; Worsening = increase score > 0 %. | Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT | 
| Change From Baseline in Acne Graded by Leeds Technique | Leeds Grading technique: evaluates three sites (face, back, chest) on a 0 to 10 grading scale where 0 equals to no acne and 10 equals to most severe acne. | Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT |