Background: There is limited direct comparative data on imiquimod versus cryotherapy to treat actinic keratoses.

Objective: Compare lesion response through 12 months post-initial treatment.

Methods: Patients with ≥ 10 lesions on the face or scalp were randomized to cryotherapy (up to 10 lesions per session, up to 4 sessions, every 3 months) or imiquimod (3-times-per-week for 3-4 weeks, up to 2 courses) with repeat treatment depending on response.

Results: In 36 patients assigned to cryotherapy and 35 to imiquimod, lesion complete response rates were 85.0 percent (306/360) and 66.9 percent (234/350) for cryotherapy and imiquimod, respectively (P<0.0002). For completely cleared lesions, global skin quality was excellent in 82 percent (250/306) versus 100 percent (234/234) for cryotherapy and imiquimod, respectively (P<0.0001). More cryotherapy than imiquimod patients had hypopigmentation (54.8% versus 24.0%, P=0.0197), as well as blister formation, redness/erythema, flaking/scaling/dryness, and scabbing/crusting (P<0.05).

Conclusion: 12-month lesion complete clearance rate was higher with repeated cryotherapy, but cosmetic outcome was better with imiquimod.

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