Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris

This study has been completed.

Study NCT00835198 Information provided by Allergan

First Received on January 30, 2009. Last Updated on September 22, 2011 History of Changes

Results First Received: September 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Acne Vulgaris
Interventions:	Drug: Dapsone; Tretinoin Drug: Tretinoin

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
Tretinoin Gel 0.025%	Tretinoin gel 0.025%
Dapsone Gel 5% and Tretinoin Gel 0.025%	Dapsone gel 5% and Tretinoin gel 0.025%

Participant Flow: Overall Study

	Tretinoin Gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025%
STARTED	82	81
COMPLETED	74	74
NOT COMPLETED	8	7

Baseline Characteristics

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Reporting Groups

	Description
Tretinoin Gel 0.025%	Tretinoin gel 0.025%
Dapsone Gel 5% and Tretinoin Gel 0.025%	Dapsone gel 5% and Tretinoin gel 0.025%

Baseline Measures

	Tretinoin Gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025%	Total
Number of Participants [units: participants]	82	81	163
Age [units: years] Median ( Full Range )	20.2 ( 12.1 to 46.1 )	19.7 ( 12.5 to 52.2 )	20.0 ( 12.1 to 52.2 )
Gender [units: participants]
Female	44	38	82
Male	38	43	81

Outcome Measures

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1. Primary:

Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 [ Time Frame: Baseline, Week 12 ]

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2. Secondary:

Change From Baseline in Investigator Global Assessment at Week 12 [ Time Frame: Baseline, Week 12 ]

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3. Secondary:

Change From Baseline in Overall Disease Severity at Week 12 [ Time Frame: Baseline, Week 12 ]

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4. Secondary:

Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 [ Time Frame: Baseline, 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. Restriction Description: A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo

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: Vice President Medical Affairs
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00835198 History of Changes
Other Study ID Numbers:	MA-ACZ0801
Study First Received:	January 30, 2009
Results First Received:	September 22, 2011
Last Updated:	September 22, 2011
Health Authority:	United States: Institutional Review Board