Status:
TERMINATED
Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne
Lead Sponsor:
Pfizer
Conditions:
Acne Vulgaris
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 minocyclin...
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.
Eligibility Criteria
Inclusion
- 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
- pregnancy, gastrointestinal and endocrinological disease, specific systemic disease, hormonal contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00392223
Start Date
October 1 2007
End Date
June 1 2008
Last Update
January 12 2010
Active Locations (17)
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1
Pfizer Investigational Site
Germona Del Friuli, Udine, Italy, 33013
2
Pfizer Investigational Site
Bologna, Italy, 40121
3
Pfizer Investigational Site
Catania, Italy, 95124
4
Pfizer Investigational Site
Catanzaro, Italy, 88100