Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-label, Assessor-blinded, Split-face Study of Imiquimod 5% Cream Applied After Cryotherapy of Actinic Keratoses|
- Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment [ Time Frame: Baseline, 4-8 weeks post-treatment ] [ Designated as safety issue: No ]Percent change = [(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)]/(actinic keratoses count at baseline)]*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.
- Cosmetic Appearance Score at 4-8 Weeks Post-treatment [ Time Frame: 4-8 weeks post-treatment ] [ Designated as safety issue: No ]Cosmetic appearance score, based recall comparison to appearance at baseline. Seven point scale: +3 = treatment area is much better appearing; +2 = treatment area is moderately better appearing; + 1 = treatment area is slightly better appearing; 0 = treatment area appears same; -1 = treatment area is slightly worse appearing; -2 = treatment area is moderately worse appearing; -3 = treatment area is much worse appearing. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.
- Local Skin Reactions [ Time Frame: Post baseline to end of study (4-8 weeks post-treatment) ] [ Designated as safety issue: Yes ]Mean maximum post-baseline intensity of investigator assessed local skin reactions (erythema, edema, weeping/exudate, flaking/scaling/dryness, scabbing/crusting, erosion/ulceration) by treatment area. 0 = none, 1 = mild, 2 = moderate, 3 = severe. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.
|Study Start Date:||October 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Imiquimod, treatment, topical cream
Imiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp
Drug: imiquimod 5% cream
1 packet (250 mg cream) 3 times per week for 4 weeks
Other Name: Aldara
No Intervention: Control, Untreated
No treatment of treatment area on the other half of the face and/or balding scalp
Actinic keratoses are common skin lesions associated with excess sun exposure. Over time, there is a small risk a lesion may progress to skin cancer. Since one can not predict which actinic keratosis will progress, the standard of care is to treat the lesions. The most commonly used method to treat actinic keratoses in the United States is with cryotherapy, which uses intense cold to freeze and destroy the lesions. Efficacy appears to be related to how long one freezes the lesion, but increasing the freeze time may result in increased pain and/or skin pigment changes after treatment.
Cryotherapy is a provider-administered "focal" treatment that only treats the lesions that are frozen. There may be early actinic keratoses in the skin surrounding treated lesions that are not easily seen; these may progress over time to visible lesions. There several patient-administered topical treatments for actinic keratoses that are applied to a treatment area or "field" rather than to specific lesions. Imiquimod 5% cream is one such treatment, and is approved in the United States for the treatment of AKs with a dosing regimen of 1 packet applied 2 times per week to a 25 cm2 area 2x/week for 16 weeks.
The study will use a split-face design (one side of face treated and the other side untreated) to explore whether a 4-week course of topical imiquimod 5% cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) in the treatment area at follow-up.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774787
|United States, Florida|
|Spencer Dermatology and Skin Surgery|
|Saint Petersburg, Florida, United States, 33716|
|United States, Nevada|
|James Del Rosso|
|Henderson, Nevada, United States, 89129|
|United States, New York|
|New York, New York, United States, 10016|
|Study Chair:||Darrell S Rigel, MD||Rigel Dermatology|
|Principal Investigator:||James Q Del Rosso, DO||Private Practice|
|Principal Investigator:||James Spencer||Spencer Dermatology|