Condition(s) treated: Acne Vulgaris

Intervention: Azithromycin microspheres (Drug); minocycline-placebo capsules (Drug); Azithromycin microspheres-placebo (Drug); Minocycline capsules, (Drug)

Phase: Phase 3

Enrollment status: Recruiting

Sponsor: Pfizer

Principal investigator(s) or official(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

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.

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

Primary outcome: 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))

Secondary outcome:
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)

Internal comparison of pre-post therapy GAGS score, in both group of treatment. (Time Frame: visit 2 EOT after 8 weeks of treatment)

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)

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)

evaluation 4. Light improvement: reduction <25% of score between pre-post evaluation. (Time Frame: visit 2 EOT after 8 weeks of treatment)

Minimum eligible age: 16 Years. Eligible gender(s): Both.

Criteria:

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)

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Napoli 80131, Italy; Active, not recruiting

Pfizer Investigational Site, Ferrara 44100, Italy; Active, not recruiting

Pfizer Investigational Site, Bologna 40121, Italy; Completed

Pfizer Investigational Site, Milano 20100, Italy; Active, not recruiting

Pfizer Investigational Site, Trieste 34100, Italy; Recruiting

Pfizer Investigational Site, Messina 98100, Italy; Recruiting

Pfizer Investigational Site, Pordenone 33170, Italy; Recruiting

Pfizer Investigational Site, Lucca 55100, Italy; Active, not recruiting

Pfizer Investigational Site, Siena 53100, Italy; Active, not recruiting

Pfizer Investigational Site, Pisa 56126, Italy; Active, not recruiting

Pfizer Investigational Site, Roma 00161, Italy; Recruiting

Pfizer Investigational Site, Roma 00167, Italy; Recruiting

Pfizer Investigational Site, Terni 05100, Italy; Active, not recruiting

Pfizer Investigational Site, Genova 16132, Italy; Active, not recruiting

Pfizer Investigational Site, Catania 95124, Italy; Recruiting

Pfizer Investigational Site, Catanzaro 88100, Italy; Completed

Pfizer Investigational Site, Germona del Friuli, Udine 33013, Italy; Recruiting

To obtain contact information for a study center near you, click here.

Start date: December 2006
Last updated: June 6, 2008

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