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

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

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.

Study Overview

• Status: Completed
• Conditions: Keratosis
• Intervention / Treatment: Drug: imiquimod cream

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.

• Study Type: Interventional
• Enrollment (Actual): 551
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85044
  • 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
  • Colorado
    • Denver, Colorado, United States, 80210
  • Connecticut
    • New Britain, Connecticut, United States, 06052
  • Florida
    • Coral Gables, Florida, United States, 33134
    • Hollywood, Florida, United States, 33021
    • Miami, Florida, United States, 33175
    • West Palm Beach, Florida, United States, 33401
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
  • Indiana
    • Indianapolis, Indiana, United States, 46256
  • Louisiana
    • Metairie, Louisiana, United States, 70006
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
  • Minnesota
    • Chaska, Minnesota, United States, 55318
  • Nevada
    • Henderson, Nevada, United States, 89052
    • Henderson, Nevada, United States, 89014
    • Reno, Nevada, United States, 89509
    • Reno, Nevada, United States, 89521
  • New York
    • New York, New York, United States, 10021
  • North Carolina
    • High Point, North Carolina, United States, 27262
    • Raleigh, North Carolina, United States, 27612
    • Winston-Salem, North Carolina, United States, 27106
  • Oregon
    • Portland, Oregon, United States, 97210
  • Pennsylvania
    • Flourtown, Pennsylvania, United States, 19031
  • Texas
    • Arlington, Texas, United States, 76011
    • San Antonio, Texas, United States, 78229
  • Virginia
    • Woodbridge, Virginia, United States, 22191
  • Washington
    • Spokane, Washington, United States, 99204
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53207

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Aldara® (imiquimod) cream 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced an Adverse Event	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.	from first dose up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count	Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count	At Month 18

Collaborators and Investigators

• Sponsor: Graceway Pharmaceuticals, LLC
• Investigators: Study Director: Sharon Levy, MD, Graceway Pharmaceuticals

Publications and helpful links

General Publications

• Del Rosso JQ, Sofen H, Leshin B, Meng T, 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. J Clin Aesthet Dermatol. 2009 Apr;2(4):20-8.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: June 30, 2005
• First Submitted That Met QC Criteria: June 30, 2005
• First Posted (Estimate): July 1, 2005

Study Record Updates

• Last Update Posted (Estimate): July 20, 2010
• Last Update Submitted That Met QC Criteria: July 14, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: actinic keratosis; actinic keratosis lesions large head torso extremities
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferon Inducers; Imiquimod
• Other Study ID Numbers: 1520-IMIQ