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NCT00392223 Clinical Trial

Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

Acne Vulgaris Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00392223
Other study ID # A0661150
Secondary ID
Status Terminated
Phase Phase 3
First received October 23, 2006
Last updated January 5, 2010
Start date October 2007
Est. completion date June 2008

Study information
Verified date January 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 118
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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
• minocycline-placebo capsules
minocycline-placebo capsules daily for 8 weeks plus minocycline placebo
• 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.
• Minocycline capsules,
Capsules, PO, 100 mg daily for 8 weeks.

Locations
Country Name City State
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Catania
Italy Pfizer Investigational Site Catanzaro
Italy Pfizer Investigational Site Ferrara
Italy Pfizer Investigational Site Genova
Italy Pfizer Investigational Site Germona Del Friuli Udine
Italy Pfizer Investigational Site Lucca
Italy Pfizer Investigational Site Messina
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Napoli
Italy Pfizer Investigational Site Pisa
Italy Pfizer Investigational Site Pordenone
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Siena
Italy Pfizer Investigational Site Terni
Italy Pfizer Investigational Site Trieste

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score Baseline, Week 8 End of Treatment (EOT) No
Primary Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population Baseline, Week 8 EOT No
Secondary Change From Baseline in Global Acne Grading System (GAGS) Score Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT No
Secondary Improvement of Global Acne Grading System (GAGS) Score Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT No
Secondary Change From Baseline in Acne Graded by Leeds Technique Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT No
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