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
• 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

• Acne Vulgaris

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

External Links

•   To obtain contact information for a study center near you, click here.