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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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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Frequency Threshold

Threshold above which other adverse events are reported	>or= 0%

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)

Other Adverse Events

	Azithromycin	Minocycline
Total, other (not including serious) adverse events
# participants affected	29	21
Eye disorders
Eyelid edema ^†^A # participants affected / at risk	0/58 (0.00%)	1/60 (1.67%)
Gastrointestinal disorders
Abdominal pain * ^B # participants affected / at risk	7/58 (12.07%)	3/60 (5.00%)
Abdominal pain, upper ^†^B # participants affected / at risk	5/58 (8.62%)	2/60 (3.33%)
Constipation ^†^B # participants affected / at risk	1/58 (1.72%)	0/60 (0.00%)
Diarrhea ^†^B # participants affected / at risk	10/58 (17.24%)	2/60 (3.33%)
Gastritis ^†^B # participants affected / at risk	2/58 (3.45%)	1/60 (1.67%)
Gastrointestinal disorder ^†^B # participants affected / at risk	1/58 (1.72%)	0/60 (0.00%)
Nausea ^†^B # participants affected / at risk	5/58 (8.62%)	1/60 (1.67%)
Vomiting ^†^B # participants affected / at risk	5/58 (8.62%)	2/60 (3.33%)
General disorders
Fatigue ^†^B # participants affected / at risk	1/58 (1.72%)	0/60 (0.00%)
Malaise ^†^B # participants affected / at risk	2/58 (3.45%)	0/60 (0.00%)
Pyrexia ^†^B # participants affected / at risk	2/58 (3.45%)	4/60 (6.67%)
Immune system disorders
Hypersensitivity ^†^B # participants affected / at risk	0/58 (0.00%)	2/60 (3.33%)
Infections and infestations
Furnucle ^†^B # participants affected / at risk	1/58 (1.72%)	0/60 (0.00%)
Influenza ^†^B # participants affected / at risk	1/58 (1.72%)	1/60 (1.67%)
Localized infection ^†^B # participants affected / at risk	0/58 (0.00%)	1/60 (1.67%)
Nasopharyngitis ^†^B # participants affected / at risk	2/58 (3.45%)	2/60 (3.33%)
Otitis media acute ^†^B # participants affected / at risk	0/58 (0.00%)	1/60 (1.67%)
Pharyngitis ^†^B # participants affected / at risk	0/58 (0.00%)	2/60 (3.33%)
Tonsillitis ^†^B # participants affected / at risk	1/58 (1.72%)	1/60 (1.67%)
Injury, poisoning and procedural complications
Joint dislocation ^†^B # participants affected / at risk	0/58 (0.00%)	1/60 (1.67%)
Investigations
Alanine aminotransferase increased ^†^B # participants affected / at risk	0/58 (0.00%)	2/60 (3.33%)
Metabolism and nutrition disorders
Anorexia * ^B # participants affected / at risk	1/58 (1.72%)	0/60 (0.00%)
Nervous system disorders
Disturbance in attention ^†^B # participants affected / at risk	1/58 (1.72%)	0/60 (0.00%)
Headache ^†^B # participants affected / at risk	1/58 (1.72%)	3/60 (5.00%)
Reproductive system and breast disorders
Migraine ^†^B # participants affected / at risk	0/58 (0.00%)	1/60 (1.67%)
Dysmenorrhea ^†^B # participants affected / at risk	0/58 (0.00%)	1/60 (1.67%)
Skin and subcutaneous tissue disorders
Rash ^†^B # participants affected / at risk	0/58 (0.00%)	1/60 (1.67%)

^†	Indicates events were collected by systematic assessment.
*	Indicates events were collected by non-systematic assessment.
^A	Term from vocabulary, MedDRA 11.1
^B	Term from vocabulary, MedDRA 11.1

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