Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

Phase 3TerminatedNCT00392223

Pfizer118 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

118

Conditions

Acne Vulgaris

Interventions

Azithromycin microspheresDRUG

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

minocycline-placebo capsulesDRUG

minocycline-placebo capsules daily for 8 weeks plus minocycline placebo

Azithromycin microspheres-placeboDRUG

Minocycline capsules, PO, 100 mg daily for 8 weeks and Azithromycin microspheres-placebo once a week for 8 weeks plus azithromycin placebo.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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)

Locations (17)

Pfizer Investigational Site

Germona Del Friuli, Udine, Italy

Pfizer Investigational Site

Bologna, Italy

Pfizer Investigational Site

Catania, Italy

Outcomes

Primary Outcomes

Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score

GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.

Time frame: Baseline, Week 8 End of Treatment (EOT)

Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population

Time frame: Baseline, Week 8 EOT

Secondary Outcomes

Change From Baseline in Global Acne Grading System (GAGS) Score

GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi. Global score factored based on summing of local scores. Change: mean at observation minus baseline.

Time frame: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT

Improvement of Global Acne Grading System (GAGS) Score

Number of subjects by improvement category of GAGS score: Best improvement = reduction of GAGS score \>75% (pre-post evaluation); Good improvement = reduction score \> 50 - 75%; Moderate improvement : reduction score \> 25 - 50%; Light improvement : reduction score \> 0 - 25%; No change = reduction score = 0%; Worsening = increase score \> 0 %.

Time frame: Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT

Data from ClinicalTrials.gov

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