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 Medicis Global Service Corporation

First Received on June 30, 2005. Last Updated on July 14, 2010 History of Changes

Results First Received: October 21, 2008

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
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: Overall Study

	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
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	22
Not Hispanic or Latino	529
Unknown or Not Reported	0
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
Region of Enrollment [units: participants]
United States	551
Baseline actinic keratosis lesion count [units: actinic keratosis lesions] Mean ± Standard Deviation	45.5 ± 2.36

Outcome Measures

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1. Primary:

Number of Participants Who Experienced an Adverse Event [ Time Frame: from first dose up to 18 months ]

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2. Secondary:

Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count [ Time Frame: 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

Publications of Results:

Del Rosso JQ, Sofen H, Leshin B, Meng TC, Kulp J, Levy S. Safety and Efficacy of Multiple 16-week Courses of Topical Imiquimod for the Treatment of Large Areas of Skin Involved with Actinic Keratoses. Clin Aesthetic Dermatol. 2009;2(4):20-28.

Responsible Party:	Sharon Levy, MD VP Product Development, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00116649 History of Changes
Other Study ID Numbers:	1520-IMIQ
Study First Received:	June 30, 2005
Results First Received:	October 21, 2008
Last Updated:	July 14, 2010
Health Authority:	United States: Food and Drug Administration