Evaluation of Irritation That Potentially Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face

This study has been completed.

Study NCT00952523 Information provided by Johnson & Johnson Consumer & Personal Products Worldwide

First Received on August 4, 2009. Last Updated on October 4, 2011 History of Changes

Results First Received: January 26, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Acne Vulgaris
Interventions:	Drug: Tretinoin Facial Gel Drug: Adapalene/Benzoyl Peroxide Facial 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
Tretinoin & Adapalene-Benzoyl Peroxide	Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model

Participant Flow: Overall Study

	Tretinoin & Adapalene-Benzoyl Peroxide
STARTED	162
COMPLETED	155
NOT COMPLETED	7
Withdrawal by Subject	7

Baseline Characteristics

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Reporting Groups

	Description
Tretinoin & Adapalene-Benzoyl Peroxide	Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model

Baseline Measures

	Tretinoin & Adapalene-Benzoyl Peroxide
Number of Participants [units: participants]	162
Age [units: years] Mean ± Standard Deviation	31 ± 8.2
Gender [units: participants]
Female	141
Male	21
Region of Enrollment [units: participants]
United States	162

Outcome Measures

1. Primary:

Facial Irritation and Cutaneous Effects [ Time Frame: three 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: Joyce Hauze, Senior Project Manager, Clinical Research Operations
Organization: J&J Consumer and Personal Products Worldwide
phone: 928-277-0715
e-mail: jhauze@its.jnj.com

Publications of Results:

Leyden JJ, Nighland M, Rossi AB, Ramaswamy R. Irritation potential of tretinoin gel microsphere pump versus adapalene plus benzoyl peroxide gel. J Drugs Dermatol. 2010 Aug;9(8):998-1003.

Responsible Party:	Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00952523 History of Changes
Other Study ID Numbers:	CA-P-7190
Study First Received:	August 4, 2009
Results First Received:	January 26, 2010
Last Updated:	October 4, 2011
Health Authority:	United States: Institutional Review Board