A Randomized, Open-label, Assessor-blinded, Split-face Study of Imiquimod 5% Cream Applied After Cryotherapy of Actinic Keratoses
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment
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.
Baseline, 4-8 weeks post-treatment
Darrell S Rigel, MD
United States: Institutional Review Board
|Spencer Dermatology and Skin Surgery||Saint Petersburg, Florida 33716-1115|
|James Del Rosso||Henderson, Nevada 89129|
|Rigel Dermatology||New York, New York 10016|