COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH:
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00116649
Recruitment Status : Completed
First Posted : July 1, 2005
Results First Posted : November 25, 2008
Last Update Posted : July 20, 2010
Information provided by:
Graceway Pharmaceuticals, LLC

Brief Summary:
Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.

Condition or disease Intervention/treatment Phase
Keratosis Drug: imiquimod cream Phase 4

Detailed Description:

This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the United States.

This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment areas could be exposed (i.e., head, torso and/or extremities), with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for 16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month, treatment-free follow-up period.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 551 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Safety and Pharmacokinetic Study of AldaraTM (Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis
Study Start Date : June 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: Aldara 5%
Aldara® (imiquimod) cream, 5% supplied in 250 mg single-use packets.
Drug: imiquimod cream
imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles
Other Name: Aldara® (imiquimod) cream 5%

Primary Outcome Measures :
  1. Number of Participants Who Experienced an Adverse Event [ Time Frame: from first dose up to 18 months ]
    Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. 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.

Secondary Outcome Measures :
  1. Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count [ Time Frame: At Month 18 ]
    Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Are at least 18 years of age.
  • Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.

Exclusion Criteria:

  • Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).
  • Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00116649

Layout table for location information
United States, Arizona
Phoenix, Arizona, United States, 85044
United States, California
Encino, California, United States, 91436
Los Angeles, California, United States, 90045
Riverside, California, United States, 92506
San Diego, California, United States, 92117
Santa Monica, California, United States, 90404
United States, Colorado
Denver, Colorado, United States, 80210
United States, Connecticut
New Britain, Connecticut, United States, 06052
United States, Florida
Coral Gables, Florida, United States, 33134
Hollywood, Florida, United States, 33021
Miami, Florida, United States, 33175
West Palm Beach, Florida, United States, 33401
United States, Illinois
Arlington Heights, Illinois, United States, 60005
United States, Indiana
Indianapolis, Indiana, United States, 46256
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Boston, Massachusetts, United States, 02118
United States, Minnesota
Chaska, Minnesota, United States, 55318
United States, Nevada
Henderson, Nevada, United States, 89014
Henderson, Nevada, United States, 89052
Reno, Nevada, United States, 89509
Reno, Nevada, United States, 89521
United States, New York
New York, New York, United States, 10021
United States, North Carolina
High Point, North Carolina, United States, 27262
Raleigh, North Carolina, United States, 27612
Winston-Salem, North Carolina, United States, 27106
United States, Oregon
Portland, Oregon, United States, 97210
United States, Pennsylvania
Flourtown, Pennsylvania, United States, 19031
United States, Texas
Arlington, Texas, United States, 76011
San Antonio, Texas, United States, 78229
United States, Virginia
Woodbridge, Virginia, United States, 22191
United States, Washington
Spokane, Washington, United States, 99204
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53207
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
Layout table for investigator information
Study Director: Sharon Levy, MD Graceway Pharmaceuticals
Publications of Results:
Layout table for additonal information
Responsible Party: Sharon Levy, MD VP Product Development, Graceway Pharmaceuticals Identifier: NCT00116649    
Other Study ID Numbers: 1520-IMIQ
First Posted: July 1, 2005    Key Record Dates
Results First Posted: November 25, 2008
Last Update Posted: July 20, 2010
Last Verified: July 2010
Keywords provided by Graceway Pharmaceuticals, LLC:
actinic keratosis lesions large head torso extremities
actinic keratosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers