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Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00392223
First received: October 23, 2006
Last updated: January 5, 2010
Last verified: January 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
 Drug: Azithromycin microspheres
Drug: minocycline-placebo capsules
Drug: Azithromycin microspheres-placebo
Drug: Minocycline capsules,
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Improvement of Global Acne Grading System (GAGS) Score [ Time Frame: Week 4, Week 8 End of Treatment (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 End of Treatment (EOT), 8 weeks after EOT ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392223

Locations
Italy
Pfizer Investigational Site
Germona Del Friuli, Udine, Italy, 33013
Pfizer Investigational Site
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, 00167
Pfizer Investigational Site
Roma, Italy, 00161
Pfizer Investigational Site
Siena, Italy, 53100
Pfizer Investigational Site
Terni, Italy, 05100
Pfizer Investigational Site
Trieste, Italy, 34100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00392223     History of Changes
Other Study ID Numbers: A0661150
Study First Received: October 23, 2006
Results First Received: June 11, 2009
Last Updated: January 5, 2010
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Minocycline
 Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013