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

Show Participant Flow

Baseline Characteristics

Hide Baseline Characteristics

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

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

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) ]

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Post-Hoc:

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

Show Outcome Measure 6

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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