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.
Overview
- Phase
- Phase 3
- Intervention
- Azithromycin microspheres
- Conditions
- Acne Vulgaris
- Sponsor
- Pfizer
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score
- Status
- Terminated
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
Treatment Group A
Intervention: Azithromycin microspheres
Treatment Group A
Intervention: minocycline-placebo capsules
Treatment Group B
Intervention: Azithromycin microspheres-placebo
Treatment Group B
Intervention: Minocycline capsules,
Outcomes
Primary Outcomes
Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score
Time Frame: 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
Time Frame: 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 Outcomes
- Change From Baseline in Global Acne Grading System (GAGS) Score(Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT)
- Improvement of Global Acne Grading System (GAGS) Score(Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT)
- Change From Baseline in Acne Graded by Leeds Technique(Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT)