Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Azithromycin microspheres-placebo; Drug: Azithromycin microspheres; Drug: minocycline-placebo capsules; Drug: Minocycline capsules,

Study type: Interventional

Funder types: Industry

Identifiers

NCT00392223

A0661150

Details and patient eligibility

About

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

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 2 patient groups

Treatment Group A

Experimental group

Treatment:

Drug: minocycline-placebo capsules

Drug: Azithromycin microspheres

Treatment Group B

Experimental group

Treatment:

Drug: Azithromycin microspheres-placebo

Drug: Minocycline capsules,