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

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

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

Baseline Characteristics

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

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2