Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

January 5, 2010 updated by: Pfizer

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40121
        • Pfizer Investigational Site
      • Catania, Italy, 95124
        • Pfizer Investigational Site
      • Catanzaro, Italy, 88100
        • Pfizer Investigational Site
      • Ferrara, Italy, 44100
        • Pfizer Investigational Site
      • Genova, Italy, 16132
        • Pfizer Investigational Site
      • Lucca, Italy, 55100
        • Pfizer Investigational Site
      • Messina, Italy, 98100
        • Pfizer Investigational Site
      • Milano, Italy, 20100
        • Pfizer Investigational Site
      • Napoli, Italy, 80131
        • Pfizer Investigational Site
      • Pisa, Italy, 56126
        • Pfizer Investigational Site
      • Pordenone, Italy, 33170
        • Pfizer Investigational Site
      • Roma, Italy, 00161
        • Pfizer Investigational Site
      • Roma, Italy, 00167
        • Pfizer Investigational Site
      • Siena, Italy, 53100
        • Pfizer Investigational Site
      • Terni, Italy, 05100
        • Pfizer Investigational Site
      • Trieste, Italy, 34100
        • Pfizer Investigational Site
    • Udine
      • Germona Del Friuli, Udine, Italy, 33013
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group A
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
Experimental: Treatment Group B
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score
Time Frame: Baseline, Week 8 End of Treatment (EOT)
GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.
Baseline, Week 8 End of Treatment (EOT)
Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population
Time Frame: Baseline, Week 8 EOT
GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.
Baseline, Week 8 EOT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Global Acne Grading System (GAGS) Score
Time Frame: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi. Global score factored based on summing of local scores. Change: mean at observation minus baseline.
Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Improvement of Global Acne Grading System (GAGS) Score
Time Frame: Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Number of subjects by improvement category of GAGS score: Best improvement = reduction of GAGS score >75% (pre-post evaluation); Good improvement = reduction score > 50 - 75%; Moderate improvement : reduction score > 25 - 50%; Light improvement : reduction score > 0 - 25%; No change = reduction score = 0%; Worsening = increase score > 0 %.
Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Change From Baseline in Acne Graded by Leeds Technique
Time Frame: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Leeds Grading technique: evaluates three sites (face, back, chest) on a 0 to 10 grading scale where 0 equals to no acne and 10 equals to most severe acne.
Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

October 23, 2006

First Submitted That Met QC Criteria

October 23, 2006

First Posted (Estimate)

October 25, 2006

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 5, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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