Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne - Study Results

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

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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Measure Type	Secondary
Measure Title	Improvement of Global Acne Grading System (GAGS) Score
Measure Description	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 (EOT), 8 weeks after EOT
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.

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)

Measured Values

	Azithromycin	Minocycline
Number of Participants Analyzed [units: participants]	53	59
Improvement of Global Acne Grading System (GAGS) Score [units: participants]
Week 4 Best Improvement	1	1
Week 4 Good Improvement	4	2
Week 4 Moderate Improvement	19	25
Week 4 Light Improvement	23	24
Week 4 No Change	2	2
Week 4 Worsening	1	2
Week 4 Missing	3	3
Week 8 EOT Best Improvement	4	3
Week 8 EOT Good Improvement	11	16
Week 8 EOT Moderate Improvement	21	20
Week 8 EOT Light Improvement	11	15
Week 8 EOT No Change	2	2
Week 8 EOT Worsening	3	0
Week 8 EOT Missing	1	3
Week 8 EOT LOCF Best Improvement	4	3
Week 8 EOT LOCF Good Improvement	11	16
Week 8 EOT LOCF Moderate Improvement	21	20
Week 8 EOT LOCF Light Improvement	11	17
Week 8 EOT LOCF No Change	3	2
Week 8 EOT LOCF Worsening	3	1
Week 8 EOT LOCF Missing	0	0
8 weeks after EOT Best Improvement	7	6
8 weeks after EOT Good Improvement	15	17
8 weeks after EOT Moderate Improvement	13	18
8 weeks after EOT Light Improvement	6	8
8 weeks after EOT No Change	3	0
8 weeks after EOT Worsening	5	0
8 weeks after EOT Missing	4	10

No statistical analysis provided for Improvement of Global Acne Grading System (GAGS) Score

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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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661150
Study First Received:	October 23, 2006
Results First Received:	June 11, 2009
Last Updated:	June 11, 2009
ClinicalTrials.gov Identifier:	NCT00392223 History of Changes
Health Authority:	Italy: The Italian Medicines Agency