Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

This study has been terminated.

( See Detailed Description )

Study NCT00392223 Information provided by Pfizer

First Received: October 23, 2006 Last Updated: June 11, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Parallel Assignment
Condition:	Acne Vulgaris
Interventions:	Drug: Azithromycin microspheres Drug: minocycline-placebo capsules Drug: Azithromycin microspheres-placebo Drug: Minocycline capsules,

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Azithromycin	2 grams per week administered administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
Minocycline	100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)

Participant Flow: Overall Study

	Azithromycin	Minocycline
STARTED	58	60
COMPLETED	49	47
NOT COMPLETED	9	13
Adverse Event	5	4
Lost to Follow-up	1	4
Protocol Violation	0	3
Withdrawal by Subject	3	2

Baseline Characteristics

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Reporting Groups

	Description
Azithromycin	2 grams per week administered administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
Minocycline	100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)

Baseline Measures

	Azithromycin	Minocycline	Total
Number of Participants [units: participants]	58	60	118
Age, Customized [units: participants]
<18 years	10	17	27
Between 18 and 44 years	48	43	91
Gender [units: participants]
Female	35	36	71
Male	23	24	47

Outcome Measures

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1. Primary:

Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score [ Baseline, Week 8 EOT (End of Treatment) ]

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2. Primary:

Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score - Per Protocol Population [ Baseline, Week 8 EOT (End of Treatment) ]

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3. Secondary:

Change From Baseline in GAGS Score [ Baseline, Week 4, Week 8 (EOT), 8 weeks after EOT ]

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4. Secondary:

Improvement of Global Acne Grading System (GAGS) Score [ Week 4, Week 8 (EOT), 8 weeks after EOT ]

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5. Secondary:

Change From Baseline in Acne Graded by Leeds Technique [ Baseline, Week 4, Week 8 EOT, 8 weeks after EOT ]

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6. Post-Hoc:

Number of Subjects With Mild, Moderate, and Severe Acne [ Baseline, Week 8 EOT ]

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