Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

This study has been completed.

Study NCT00635609 Information provided by Warner Chilcott

First Received on March 7, 2008. Last Updated on December 22, 2010 History of Changes

Results First Received: September 23, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Acne Vulgaris
Interventions:	Drug: Doxycycline hyclate (Doryx) Drug: Doxycycline hyclate

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
Doxycycline Hyclate (Doryx) Delayed-release Tablets	Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
Doxycycline Hyclate Immediate-release Tablets	Doxycycline hyclate immediate-release tablets, 100 mg once daily

Participant Flow: Overall Study

	Doxycycline Hyclate (Doryx) Delayed-release Tablets	Doxycycline Hyclate Immediate-release Tablets
STARTED	48	45
COMPLETED	41	42
NOT COMPLETED	7	3

Baseline Characteristics

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Reporting Groups

	Description
Doxycycline Hyclate (Doryx) Delayed-release Tablets	Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
Doxycycline Hyclate Immediate-release Tablets	Doxycycline hyclate immediate-release tablets, 100 mg once daily

Baseline Measures

	Doxycycline Hyclate (Doryx) Delayed-release Tablets	Doxycycline Hyclate Immediate-release Tablets	Total
Number of Participants [units: participants]	48	45	93
Age [units: participants]
<=18 years	28	21	49
Between 18 and 65 years	20	24	44
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	19.3 ± 5.8	20.9 ± 7.9	20.1 ± 6.9
Gender [units: participants]
Female	17	16	33
Male	31	29	60
Region of Enrollment [units: participants]
United States	48	45	93
Ethnic Origin [units: participants]
Hispanic	27	26	53
Not of Hispanic origin	21	19	40
Race [units: participants]
Asian or Pacific Islander	0	1	1
Black	3	5	8
Caucasian	22	18	40
Other	23	21	44

Outcome Measures

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1. Primary:

Successful Outcome According to Investigator's Global Assessment (IGA) [ Time Frame: baseline and 12 weeks ]

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2. Primary:

Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks [ Time Frame: baseline and 12 weeks ]

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3. Secondary:

Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks [ Time Frame: baseline and 12 weeks ]

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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:	NCT00635609 History of Changes
Other Study ID Numbers:	PR-08607
Study First Received:	March 7, 2008
Results First Received:	September 23, 2009
Last Updated:	December 22, 2010
Health Authority:	United States: Institutional Review Board