Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
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Purpose
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 |
|---|---|---|
|
Keratosis |
Drug: imiquimod cream |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Number of Participants Who Experienced an Adverse Event [ Time Frame: from first dose up to 18 months ] [ Designated as safety issue: Yes ]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.
- Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count [ Time Frame: At Month 18 ] [ Designated as safety issue: No ]Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count
| 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 |
|---|---|
|
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%
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Show 32 Study Locations| Study Director: | Sharon Levy, MD | Graceway Pharmaceuticals |
More Information
Publications:
| 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 |
Keywords provided by Graceway Pharmaceuticals, LLC:
|
actinic keratosis lesions large head torso extremities actinic keratosis |
Additional relevant MeSH terms:
|
Skin Abnormalities Congenital Abnormalities Keratosis Keratosis, Actinic Ichthyosis Keratoacanthoma Skin Diseases Precancerous Conditions Neoplasms |
Infant, Newborn, Diseases Imiquimod Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Interferon Inducers |
ClinicalTrials.gov processed this record on May 23, 2013