Clinical trial NCT00392223: Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-25
Enrollment: 118
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score
timeFrame: Baseline, Week 8 End of Treatment (EOT)
measure: Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population
timeFrame: Baseline, Week 8 EOT
Secondary outcomes:
measure: Change From Baseline in Global Acne Grading System (GAGS) Score
timeFrame: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
measure: Improvement of Global Acne Grading System (GAGS) Score
timeFrame: Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
measure: Change From Baseline in Acne Graded by Leeds Technique
timeFrame: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Other outcomes:
Locations:
city: Germona Del Friuli
country: Italy
facility: Pfizer Investigational Site
state: Udine
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Catanzaro
country: Italy
facility: Pfizer Investigational Site
city: Ferrara
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Lucca
country: Italy
facility: Pfizer Investigational Site
city: Messina
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Pordenone
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Terni
country: Italy
facility: Pfizer Investigational Site
city: Trieste
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: