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Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Germona Del Friuli, Udine, 33013 Italy
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acne Vulgaris
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- pregnancy, gastrointestinal and endocrinological disease, specific systemic disease,
hormonal contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)

NCT00392223
Pfizer
Terminated
Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

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Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne
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
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Acne Vulgaris
  • 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.
  • Experimental: Treatment Group A
    Interventions:
    • Drug: Azithromycin microspheres
    • Drug: minocycline-placebo capsules
  • Experimental: Treatment Group B
    Interventions:
    • Drug: Azithromycin microspheres-placebo
    • Drug: Minocycline capsules,
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
118
June 2008
June 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00392223
A0661150
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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