Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis

This study has been completed.

Study NCT00116649 Information provided by Graceway Pharmaceuticals, LLC

First Received: June 30, 2005 Last Updated: November 19, 2008 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition:	Keratosis
Intervention:	Drug: imiquimod cream

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Aldara (Imiquimod) Cream	Aldara (imiquimod) Cream 5%

Baseline Measures

	Aldara (Imiquimod) Cream
Number of Participants [units: participants]	551
Age [units: participants]
<=18 years	0
Between 18 and 65 years	207
>=65 years	344
Age [units: years] Mean ± Standard Deviation	67.5 ± 10.71
Gender [units: participants]
Female	114
Male	437
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	551
More than one race	0
Unknown or Not Reported	0
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	22
Not Hispanic or Latino	529
Unknown or Not Reported	0
Region of Enrollment [units: participants]
United States	551
Baseline actinic keratosis lesion count [units: actinic keratosis lesions]	45.5

Outcome Measures

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1. Primary:

Percentage of Participants Who Experienced an Adverse Event [ Months 1, 2, 3, 4, 6, 9, 12, 15, 18 ]

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2. Secondary:

Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count [ At Month 18 ]

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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 NOT 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.

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: Sharon Levy, MD VP Product Development
Organization: Graceway Pharmaceuticals LLC
phone: 267-948-0500
e-mail: sharon.levy@gracewaypharma.com

No publications provided

Responsible Party:	Graceway Pharmaceuticals ( Sharon Levy, MD VP Product Development )
Study ID Numbers:	1520-IMIQ
Study First Received:	June 30, 2005
Results First Received:	October 21, 2008
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00116649 History of Changes
Health Authority:	United States: Food and Drug Administration