Intense local skin reactions including skin weeping or erosion can occur after a few applications of ZYCLARA Cream and may require an interruption of dosing
Complete clearance included both those lesions present at baseline and those that were revealed during treatment; it was defined as the absence of clinically visible or palpable AK lesions in the treatment area. In 2 double-blind, randomized, placebo-controlled clinical studies, 479 subjects were treated with ZYCLARA Cream 3.75% or 2.5% or placebo once daily for two 2-week treatment cycles separated by a 2-week, no-treatment period and followed for 8 weeks to end of study. The primary efficacy endpoint was complete clearance of AK lesions at Week 14 End of Study. 1,2
Secondary efficacy endpoints included partial clearance rate, defined as proportion of subjects at EOS with > 75% reduction in the number of AK lessons.1,3 Partial clearance of AK lesions in Studies 1 and 2 were 46% and 73% for patients on Zyclara 3.75% vs 19% and 27% for placebo patients, respectively (P < 0.001). 1,2
Flu like symptoms may accompany, or even precede, local skin reactions and may include fatigue, nausea, fever, myalgias, arthralgais, malaise, and chills
Large treatment area – full face or balding scalp (up to 200 cm2)1
Median 9 AK lesions2
This secondary endpoint was the percent change from baseline to Week 14 in investigator counts of AK lesions.2
Efficacy for the full-field treatment of actinic keratosis
From the publishers of Practical Dermatology, the dermtube video features commentary from thought leaders for the management of actinic keratosis.
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ZYCLARA (imiquimod) Cream 3.75% is indicated for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults.
References: 1. ZYCLARA Cream Package Insert.Scottsdale, AZ: Medicis, the Dermatology Company; February 2012. 2. Data on file. Valeant Pharmaceuticals International Inc. 3. Jorizzo JL, Markowitz O,Lebwohl MG, et al. A randomized, double-blinded, placebo-controlled, multicenter, efficacy and safety study of 3.75% imiquimod cream following cryosurgery for the treatment of actinic keratoses. J Drugs Dermatol. 2010;9(9):1101–1108.