| Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne |
| 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. |
| 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 |
| 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. |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment |
| Acne Vulgaris |
- Drug: Azithromycin microspheres
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
- Drug: minocycline-placebo capsules
minocycline-placebo capsules daily for 8 weeks plus minocycline placebo
- Drug: Azithromycin microspheres-placebo
Minocycline capsules, PO, 100 mg daily for 8 weeks and Azithromycin microspheres-placebo once a week for 8 weeks plus azithromycin placebo.
- Drug: Minocycline capsules,
Capsules, PO, 100 mg daily for 8 weeks.
|
- Experimental: Treatment Group A
Interventions:
- Drug: Azithromycin microspheres
- Drug: minocycline-placebo capsules
- Experimental: Treatment Group B
Interventions:
- Drug: Azithromycin microspheres-placebo
- Drug: Minocycline capsules,
|
| Not Provided |
| |
| Terminated |
| 118 |
| June 2008 |
| June 2008 (Final data collection date for primary outcome measure) |
|
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)
|
| Sexes Eligible for Study: |
All |
|
| 16 Years and older (Child, Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Italy |
| |
| |
| NCT00392223 |
| A0661150 |
| Not Provided |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| January 2010 |
