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Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

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ClinicalTrials.gov Identifier: NCT00392223
Recruitment Status : Terminated (See Detailed Description)
First Posted : October 25, 2006
Results First Posted : August 3, 2009
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE October 23, 2006
First Posted Date  ICMJE October 25, 2006
Results First Submitted Date  ICMJE June 11, 2009
Results First Posted Date  ICMJE August 3, 2009
Last Update Posted Date January 12, 2010
Study Start Date  ICMJE October 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2010)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2006)
  • 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
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2010)
  • 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.
  • 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 %.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2006)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Treatment Group A
    Interventions:
    • Drug: Azithromycin microspheres
    • Drug: minocycline-placebo capsules
  • Experimental: Treatment Group B
    Interventions:
    • Drug: Azithromycin microspheres-placebo
    • Drug: Minocycline capsules,
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 30, 2008)
118
Original Enrollment  ICMJE
 (submitted: October 23, 2006)
212
Actual Study Completion Date  ICMJE June 2008
Actual 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00392223
Other Study ID Numbers  ICMJE A0661150
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2010

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