November 21, 2018

The investigators concluded that resiquimod 0.03% gel is more effective than resiquimod 0.01% gel.

The use of resiquimod gel 0.03%/0.01% is effective for the treatment of actinic keratosis (AK) on the balding scalp, forehead, and face, according to the results of a multicenter study (ClinicalTrials.gov identifier: NCT01583816) published in the British Journal of Dermatology.

The investigators sought to explore the optimal dosing regimens of the toll-like receptor (TLR)7/8 antagonist resiquimod for the treatment of AK with respect to efficacy, safety, and tolerability. A total of 217 patients with AK lesions were randomly assigned to resiquimod 0.03% gel once-daily application in one of three treatments arms: 3 times a week for 4 weeks (Arm 1); 7 times within 2 weeks (Arm 2); or 5 times in 1 week (Arm 3). In 2 additional treatment arms, patients applied either resiquimod gel 0.01% 3 times weekly (Arm 4), or resiquimod 0.03% gel 3 times weekly (Arm 5), up to a biologic end point defined by skin erosion or for a maximum duration of 8 weeks. Clearance of lesions was evaluated both clinically and histologically.

Eligible patients were >age 18 ≥2 clinically (1 biopsied) diagnosed AK lesions on the balding scalp, forehead, or face. All patients self-administered the gel topically to predefined treatment areas based on dosage and trial schedules.

Complete clinical clearance of lesions ranged from 56% to 85%, with the highest rate of clearance reported in Arm 2. Resiquimod 0.03% gel was more effective than resiquimod 0.01% gel. Clearance rates in Arms 1, 2, and 3, achieved with 24, 14, and 10 gel applications, respectively, were comparable and were higher than with placebo.

In the intent-to-treat population, the overall complete clinical clearance rate at the conclusion of the study was 67% (P =.001 vs placebo), 72% (P =.004 vs placebo), 70% (P <.001 vs placebo), 56% (P =.009 vs placebo), and 74% (P <.001 vs placebo) in Arms 1, 2, 3, 4, and 5, respectively.

The investigators concluded that resiquimod 0.03% gel is more effective than resiquimod 0.01% gel. From a safety and a tolerability perspective, the lower concentration and shorter duration of resiquimod application are preferable. In Arms 2 and 3, the clinical response was achieved with fewer applications of the gel. The dosing regimens that used the biologic end point (Arms 4 and 5) were equally efficacious as predefined treatment durations and may thus be appropriate for personalized AK therapy.

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Reference

Stockfleth E, Hofbauer GFL, Reinhold U, et al. Topical resiquimod dosing regimens in patients with multiple actinic keratosis: a multi-centre, partly placebo-controlled, double-blind, clinical trial [published online September 1, 2018]. Br J Dermatol. doi:10.1111/bjd.17124