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.”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Treatment Group A
• Experimental: Treatment Group B

Primary Measures

• Compare the means of GAGS (objective grading of acne) scores reduction between baseline and visit 3 (end of treatment) in the two treatment groups
  • Time Frame: baseline and visit 3 (end of treatment)
    Safety Issue?: Yes

Secondary Measures

• After having clustered patients by the rate of severity, according to the GAGS score (see below), the size of each cluster will be compared between the two groups of treatment, at the end of treatment.
  • Time Frame: visit 2 EOT after 8 weeks of treatment
    Safety Issue?: Yes
• Internal comparison of pre-post therapy GAGS score, in both group of treatment.
  • Time Frame: visit 2 EOT after 8 weeks of treatment
    Safety Issue?: Yes
• In both groups, the different clusters of patients (by the rate of severity, and graded according the GAGS score) will be assessed, as internal comparison, in a pre-post therapy evaluation, defining:
  • Time Frame: visit 2 EOT after 8 weeks of treatment
    Safety Issue?: Yes
• 1. Best improvement: reduction > 75% of score between pre-post evaluation. 2. Good improvement: reduction >50 - 75% of score between pre-post evaluation. 3. Moderate improvement: reduction >25 - 50% of score between pre-post
  • Time Frame: visit 2 EOT after 8 weeks of treatment
    Safety Issue?: Yes
• evaluation 4. Light improvement: reduction <25% of score between pre-post evaluation.
  • Time Frame: visit 2 EOT after 8 weeks of treatment
    Safety Issue?: Yes

Inclusion Criteria:

• male and female, older than 16 years, 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, oral contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00392223

Study ID Number: A0661150

ClinicalTrials.gov Identifier: NCT00392223

Health Authority: Italy: The Italian Medicines Agency

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