Conflicts of interest This study was funded by 3M Pharmaceuticals, Saint Paul, MN, U.S.A. The investigating authors received payments for this research project. J.B., J.L. and T-C.M. were employees of 3M Pharmaceuticals at the time the study was conducted.
A phase II dose-ranging study of topical resiquimod to treat actinic keratosis
Article first published online: 9 MAY 2008
© 2008 The Authors. Journal Compilation © 2008 British Association of Dermatologists
British Journal of Dermatology
Volume 159, Issue 1, pages 205–210, July 2008
How to Cite
Szeimies, R.-M., Bichel, J., Ortonne, J.-P., Stockfleth, E., Lee, J. and Meng, T.-C. (2008), A phase II dose-ranging study of topical resiquimod to treat actinic keratosis. British Journal of Dermatology, 159: 205–210. doi: 10.1111/j.1365-2133.2008.08615.x
- Issue published online: 9 MAY 2008
- Article first published online: 9 MAY 2008
- Accepted for publication 13 February 2008
- actinic keratosis;
- toll-like receptor
Background Resiquimod, a toll-like receptor 7 and 8 agonist, may be effective as a topical treatment of actinic keratosis (AK).
Objectives To evaluate the effect of resiquimod gel concentration on lesion clearance.
Methods Patients with AK lesions on the face or balding scalp were randomly assigned to resiquimod 0·01%, 0·03%, 0·06% or 0·1% gel applied once daily three times a week for 4 weeks to a contiguous 25-cm2 area with four to eight lesions. Patients with persistent lesions received a second course after an 8-week treatment-free interval. Complete and partial lesion clearance was assessed 8 weeks after treatment for each course.
Results For the 132 patients randomized, overall complete clearance rates were 77·1% (27/35), 90·3% (28/31), 78·1% (25/32) and 85·3% (29/34) and complete clearance rates after course 1 only were 40·0%, 74·2%, 56·3% and 70·6%, respectively, for the resiquimod 0·01%, 0·03%, 0·06% and 0·1% groups. During course 1, respectively 0%, 13%, 31% and 38% of patients discontinued treatment for adverse events or local skin reactions, for the resiquimod 0·01%, 0·03%, 0·06% and 0·1% groups. Possibly or probably related nonapplication site adverse events of severe intensity, including influenza-like symptoms, were reported by 0%, 3%, 13% and 12% of patients, respectively, for the resiquimod 0·01%, 0·03%, 0·06% and 0·1% groups.
Conclusions Efficacy in clearing AK lesions was similar between the resiquimod concentrations evaluated, but resiquimod 0·01% and 0·03% were better tolerated than the higher concentrations.