Treatment of Moderate to Severe Facial Acne Vulgaris

This study has been completed.

Study NCT00612573 Information provided by Warner Chilcott

First Received on January 25, 2008. Last Updated on March 18, 2011 History of Changes

Results First Received: February 14, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Acne Vulgaris
Interventions:	Drug: Doxycycline 0.6 mg/kg/day Drug: Doxycycline 1.2 mg/kg/day Drug: Doxycycline 2.4 mg/kg/day Drug: Placebo

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
Recruitment began 4 Mar '08

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
Doxycycline 0.6 mg/kg/Day	40 mg doxycycline tablet plus 2 placebo tablets daily
Doxycycline 1.2 mg/kg/Day	80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
Doxycycline 2.4 mg/kg/Day	160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
Placebo Comparator	3 placebo tablets daily matching active 40 & 80 mg tablets

Participant Flow: Overall Study

	Doxycycline 0.6 mg/kg/Day	Doxycycline 1.2 mg/kg/Day	Doxycycline 2.4 mg/kg/Day	Placebo Comparator
STARTED	64	65	61	67
COMPLETED	52	51	52	54
NOT COMPLETED	12	14	9	13

Baseline Characteristics

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Reporting Groups

	Description
Doxycycline 0.6 mg/kg/Day	40 mg doxycycline tablet plus 2 placebo tablets daily
Doxycycline 1.2 mg/kg/Day	80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
Doxycycline 2.4 mg/kg/Day	160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
Placebo Comparator	3 placebo tablets daily matching active 40 & 80 mg tablets

Baseline Measures

	Doxycycline 0.6 mg/kg/Day	Doxycycline 1.2 mg/kg/Day	Doxycycline 2.4 mg/kg/Day	Placebo Comparator	Total
Number of Participants [units: participants]	64	65	61	67	257
Age [units: years] Mean ± Standard Deviation	19.3 ± 5.2	19.4 ± 6.6	20.7 ± 7.4	20.2 ± 7.5	19.9 ± 6.7
Age, Customized [units: Participants]
>= 18 years	32	39	27	35	133
< 18 years	32	26	34	32	124
Gender [units: participants]
Female	35	30	36	35	136
Male	29	35	25	32	121
Region of Enrollment [units: participants]
United States	64	65	61	67	257

Outcome Measures

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1. Primary:

Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population [ Time Frame: Week 12 ]

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2. Primary:

Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population [ Time Frame: Baseline to Week 12 ]

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3. Secondary:

Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population [ Time Frame: Baseline to Week 12 ]

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4. Secondary:

Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population [ Time Frame: Baseline to Week 12 ]

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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.

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
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Results Point of Contact:

Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
phone: 973-442-3376
e-mail: gwulff@wcrx.com

No publications provided

Responsible Party:	Dr. Angelo Secci, Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00612573 History of Changes
Other Study ID Numbers:	PR-07907, WC2055
Study First Received:	January 25, 2008
Results First Received:	February 14, 2011
Last Updated:	March 18, 2011
Health Authority:	United States: Food and Drug Administration