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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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study start - 14 July 2005 at 31 study centers 500 subjects were planned, with up to 15 subjects enrolled at each study center; however, some study centers were unable to enroll 15 subjects, so active centers were asked to enroll additional subjects.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Open-label study - subjects were required to be at least 18 years of age and to have greater than 25 centimeters squared total treatment area(s) containing at least 4 clinically typical, visible, discrete, nonhypertrophic Actinic Keratosis lesions without any dermatological disease and/or condition in the treatment or surrounding area.

Reporting Groups

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

Participant Flow: Baseline to Follow-up

	Aldara (Imiquimod) Cream
STARTED	551^[1]
COMPLETED	396
NOT COMPLETED	155
Adverse Event	20
Lack of Efficacy	1
Lost to Follow-up	32
Withdrawal by Subject	68
Local Skin Reaction	9
Various Reasons	18
Protocol Specified	7

[1]	586 screened (34 not eligible) 552 enrolled 551 study population (1 subject not treated)

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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Measure Type	Primary
Measure Title	Percentage of Participants Who Experienced an Adverse Event
Measure Description	Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment.
Time Frame	Months 1, 2, 3, 4, 6, 9, 12, 15, 18
Safety Issue	Yes

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.
There were 551 subjects in the Safety population, which consisted of the enrolled subjects who received at least one dose of study medication.

Reporting Groups

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

Measured Values

	Aldara (Imiquimod) Cream
Number of Participants Analyzed [units: participants]	551
Percentage of Participants Who Experienced an Adverse Event [units: percent of participants]	85.7

No statistical analysis provided for Percentage of Participants Who Experienced an Adverse Event

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