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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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<

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.

Detailed Summary:

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.


Sponsor: Graceway Pharmaceuticals, LLC

Current Primary Outcome: 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.


Original Primary Outcome: To evaluate the safety of 1, 2, or 3 16-week cycles of imiquimod for the treatment of actinic keratosis lesions totaling greater than 25 square centimeters

Current Secondary Outcome: 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


Original Secondary Outcome: To evaluate the efficacy of treatment with imiquimod in this population of subjects with actinic keratosis

Information By: Graceway Pharmaceuticals, LLC

Dates:
Date Received: June 30, 2005
Date Started: June 2005
Date Completion:
Last Updated: July 14, 2010
Last Verified: July 2010