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Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

NCT00392223 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2010-01-12

Study results available
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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

Conditions

  • Acne Vulgaris

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00392223 on ClinicalTrials.gov