Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

Phase 3

Terminated

• Conditions: Acne Vulgaris
• Interventions: Drug: Azithromycin microspheres; Drug: Azithromycin microspheres-placebo; Drug: Minocycline capsules,; Drug: minocycline-placebo capsules

• Registration Number: NCT00392223
• Lead Sponsor: Pfizer

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-10-23
• Study First Submitted QC: 2006-10-23
• Study First Posted: 2006-10-25
• Study Start: 2007-10
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-06-11
• Results First Submitted QC: 2009-06-11
• Results First Posted: 2009-08-03
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-05
• Last Update Posted: 2010-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 118

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)

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Exclusion Criteria

• pregnancy, gastrointestinal and endocrinological disease, specific systemic disease, hormonal contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group A	Azithromycin microspheres	-
Treatment Group B	Azithromycin microspheres-placebo	-
Treatment Group B	Minocycline capsules,	-
Treatment Group A	minocycline-placebo capsules	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score	Baseline, Week 8 End of Treatment (EOT)	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.
Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population	Baseline, Week 8 EOT	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Global Acne Grading System (GAGS) Score	Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT	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.
Improvement of Global Acne Grading System (GAGS) Score	Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT	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 %.
Change From Baseline in Acne Graded by Leeds Technique	Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇹 Trieste, Italy