Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris

This study has been completed.

Study NCT00834210 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 Drug: Tazarotene

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Dapsone Gel 5% and Tazarotene Cream 0.1%	Dapsone Gel 5% and Tazarotene Cream 0.1%
Tazarotene Cream 0.1%	Tazarotene Cream 0.1%

Participant Flow: Overall Study

	Dapsone Gel 5% and Tazarotene Cream 0.1%	Tazarotene Cream 0.1%
STARTED	86	85
COMPLETED	83	77
NOT COMPLETED	3	8

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Dapsone Gel 5% and Tazarotene Cream 0.1%	Dapsone Gel 5% and Tazarotene Cream 0.1%
Tazarotene Cream 0.1%	Tazarotene Cream 0.1%

Baseline Measures

	Dapsone Gel 5% and Tazarotene Cream 0.1%	Tazarotene Cream 0.1%	Total
Number of Participants [units: participants]	86	85	171
Age [units: years] Median ( Full Range )	17.8 ( 12.2 to 45.7 )	16.7 ( 12.1 to 42.9 )	17.2 ( 12.1 to 45.7 )
Gender [units: participants]
Female	48	36	84
Male	38	49	87

Outcome Measures

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 4

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: 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
No text entered.

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:	NCT00834210 History of Changes
Other Study ID Numbers:	MA-ACZ0802
Study First Received:	January 30, 2009
Results First Received:	September 22, 2011
Last Updated:	September 22, 2011
Health Authority:	United States: Institutional Review Board