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Sponsored by: |
Graceway Pharmaceuticals, LLC |
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Information provided by: | Graceway Pharmaceuticals, LLC |
ClinicalTrials.gov Identifier: | NCT00116649 |
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 | Intervention | Phase |
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Keratosis |
Drug: imiquimod cream |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 551 |
Study Start Date: | June 2005 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Aldara 5%: Experimental
Aldara® (imiquimod) cream, 5% supplied in 250 mg single-use packets.
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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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Sharon Levy, MD | Graceway Pharmaceuticals, LLC |
Responsible Party: | Graceway Pharmaceuticals ( Sharon Levy, MD VP Product Development ) |
Study ID Numbers: | 1520-IMIQ |
Study First Received: | June 30, 2005 |
Results First Received: | October 21, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00116649 History of Changes |
Health Authority: | United States: Food and Drug Administration |
actinic keratosis lesions large head torso extremities actinic keratosis |
Keratosis Immunologic Factors Skin Diseases Arnold-Chiari Malformation |
Interferons Adjuvants, Immunologic Imiquimod Tylosis |
Interferon Inducers Keratosis Immunologic Factors Skin Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Adjuvants, Immunologic Imiquimod Pharmacologic Actions |