Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00392223

Purpose

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

Condition	Intervention	Phase
Acne Vulgaris	Drug: Azithromycin microspheres Drug: minocycline-placebo capsules Drug: Azithromycin microspheres-placebo Drug: Minocycline capsules,	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Minocycline Minocycline hydrochloride Azithromycin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Internal comparison of pre-post therapy GAGS score, in both group of treatment. [ Time Frame: visit 2 EOT after 8 weeks of treatment ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
evaluation 4. Light improvement: reduction <25% of score between pre-post evaluation. [ Time Frame: visit 2 EOT after 8 weeks of treatment ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Enrollment:	118
Study Start Date:	October 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment Group A: Experimental	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
Treatment Group B: Experimental	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.

Detailed Description:

The study prematurely discontinued on the 1st of February 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

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392223

Locations

Italy
Pfizer Investigational Site
Napoli, Italy, 80131
Pfizer Investigational Site
Ferrara, Italy, 44100
Pfizer Investigational Site
Bologna, Italy, 40121
Pfizer Investigational Site
Milano, Italy, 20100
Pfizer Investigational Site
Lucca, Italy, 55100
Pfizer Investigational Site
Messina, Italy, 98100
Pfizer Investigational Site
Pordenone, Italy, 33170
Pfizer Investigational Site
Trieste, Italy, 34100
Pfizer Investigational Site
Siena, Italy, 53100
Pfizer Investigational Site
Pisa, Italy, 56126
Pfizer Investigational Site
Roma, Italy, 00161
Pfizer Investigational Site
Roma, Italy, 00167
Pfizer Investigational Site
Terni, Italy, 05100
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Catania, Italy, 95124
Pfizer Investigational Site
Catanzaro, Italy, 88100
Italy, Udine
Pfizer Investigational Site
Germona del Friuli, Udine, Italy, 33013

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661150
Study First Received:	October 23, 2006
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00392223 History of Changes
Health Authority:	Italy: The Italian Medicines Agency

Study placed in the following topic categories:

Anti-Bacterial Agents
Exanthema
Minocycline
Facial Dermatoses
Facies

Skin Diseases
Azithromycin
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Minocycline
Facial Dermatoses
Skin Diseases
Acneiform Eruptions

Therapeutic Uses
Azithromycin
Sebaceous Gland Diseases
Pharmacologic Actions
Acne Vulgaris

ClinicalTrials.gov processed this record on July 02, 2009