Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne - Tabular View

Tracking Information

First Received Date ^ICMJE

October 23, 2006

Last Updated Date

June 11, 2009

Start Date ^ICMJE

October 2007

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score [ Time Frame: Baseline, Week 8 EOT (End of Treatment) ] [ Designated as safety issue: No ]
Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score - Per Protocol Population [ Time Frame: Baseline, Week 8 EOT (End of Treatment) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Compare the means of GAGS (objective grading of acne) scores reduction between baseline
and visit 3 (end of treatment) in the two treatment groups.

Change History

Complete list of historical versions of study NCT00392223 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change From Baseline in GAGS Score [ Time Frame: Baseline, Week 4, Week 8 (EOT), 8 weeks after EOT ] [ Designated as safety issue: No ]
Improvement of Global Acne Grading System (GAGS) Score [ Time Frame: Week 4, Week 8 (EOT), 8 weeks after EOT ] [ Designated as safety issue: No ]
Change From Baseline in Acne Graded by Leeds Technique [ Time Frame: Baseline, Week 4, Week 8 EOT, 8 weeks after EOT ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

After having clustered patients by the rate of severity, according to the GAGS score,
the size of each cluster will be compared between the two groups of treatment,
at the end of treatment.
Internal comparison of pre-post therapy GAGS score in both groups of treatment.
In both groups, the different clusters of patients will be assessed, as internal
comparison, in a pre-post therapy evaluation.

Descriptive Information

Brief Title ^ICMJE

Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

Official Title ^ICMJE

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Acne Vulgaris

Intervention ^ICMJE

Drug: Azithromycin microspheres
Drug: minocycline-placebo capsules
Drug: Azithromycin microspheres-placebo
Drug: Minocycline capsules,

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

118

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00392223

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A0661150

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP