A Study of Different Use Regimens Using Two Acne Treatments

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ClinicalTrials.gov Identifier: NCT00907257

Recruitment Status : Completed

First Posted : May 22, 2009

Results First Posted : January 21, 2011

Last Update Posted : February 15, 2012

Sponsor:

Information provided by (Responsible Party):

Valeant Pharmaceuticals International, Inc.

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
Condition:	Acne Vulgaris
Interventions:	Drug: benzoyl peroxide wash Drug: Tretinoin gel

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
Same Time of Day	5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
Different Times of Day	5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening

Participant Flow: Overall Study

	Same Time of Day	Different Times of Day
STARTED	123	124
COMPLETED	110	112
NOT COMPLETED	13	12
Adverse Event	0	4
Protocol Violation	1	2
Lost to Follow-up	3	3
Withdrawal by Subject	1	2
Per IRB-Subject became vulnerable	1	0
Moved	1	0
Personal Reasons	6	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Same Time of Day	5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
Different Times of Day	5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Total	Total of all reporting groups

Baseline Measures

Same Time of Day

Different Times of Day

Total

Overall Participants Analyzed
[Units: Participants]

123

124

247

Age
[Units: Years]
Mean (Standard Deviation)

18.5 (6.86)

18.6 (6.94)

18.5 (6.89)

Gender
[Units: Participants]

Female

126

Male

121

Region of Enrollment
[Units: Participants]

United States

123

124

247

Fitzpatrick Score ^[1]
[Units: Participants]

III

^[1]	Skin type is categorized according to the Fitzpatrick skin type scale, which ranges from very fair (skin type I) to very dark (skin type VI).

Outcome Measures

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1. Primary:

Change From Baseline in Total Facial Acne Lesion Count [ Time Frame: Baseline to Week 12 ]

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2. Secondary:

Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals [ Time Frame: Baseline to Week 12 ]

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3. Secondary:

Measurement of Success [ Time Frame: Baseline to Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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.

Results Point of Contact:

Name/Title: David Lineberry
Organization: Valeant Pharmaceuticals International, Inc
phone: 949-973-1153
e-mail: David.Lineberry@valeant.com

Publications of Results:

Pariser D, Bucko A, Fried R, Jarratt MT, Kempers S, Kircik L, Lucky AW, Rafal E, Rendon M, Weiss J, Wilson DC, Rossi AB, Ramaswamy R, Nighland M. Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen. J Drugs Dermatol. 2010 Jul;9(7):805-13.

Responsible Party:	Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:	NCT00907257 History of Changes
Other Study ID Numbers:	CA-P-6270
First Submitted:	May 20, 2009
First Posted:	May 22, 2009
Results First Submitted:	December 22, 2010
Results First Posted:	January 21, 2011
Last Update Posted:	February 15, 2012

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