Vehicle-controlled, randomized, double-blind study to assess safety and efficacy of imiquimod 5% cream applied once daily 3 days per week in one or two courses of treatment of actinic keratoses on the head

Authors

  • A. Alomar,

    1. Hospital de la Santa Creu i Sant Pau, Dermatology Service, Avda. San Antonio María Claret, 167, Barcelona, Spain*3M Medica, D-41460 Neuss, Germany
      †3M Pharmaceuticals, St Paul, MN 55144, U.S.A.
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  • J. Bichel,

    1. Hospital de la Santa Creu i Sant Pau, Dermatology Service, Avda. San Antonio María Claret, 167, Barcelona, Spain*3M Medica, D-41460 Neuss, Germany
      †3M Pharmaceuticals, St Paul, MN 55144, U.S.A.
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  • S. McRae

    1. Hospital de la Santa Creu i Sant Pau, Dermatology Service, Avda. San Antonio María Claret, 167, Barcelona, Spain*3M Medica, D-41460 Neuss, Germany
      †3M Pharmaceuticals, St Paul, MN 55144, U.S.A.
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  • Conflicts of interest This study was supported by 3M Pharmaceuticals, St Paul, MN, U.S.A. J.B. is an employee of 3M Medica and S.M. is a former employee of 3M Pharmaceuticals. A.A. has received fees for consulting with 3M Pharmaceuticals.

Augustín Alomar.
E-mail: aalomar@hsp.santpau.es

Summary

Background  Imiquimod has been investigated as a safe and effective therapeutic option for the treatment of actinic keratosis (AK).

Objectives  To evaluate imiquimod vs. vehicle applied three times a week for 4 weeks in one or two courses of treatment for AK on the face or balding scalp.

Patients and methods  Patients diagnosed with AK were enrolled in this multicentre, vehicle-controlled, double-blind study conducted in Europe. Twenty study centres enrolled a total of 259 patients in this study. Patients applied the study drug for 4 weeks, entered a 4-week rest period and if they did not have complete clearance, they then entered a second course of treatment.

Results  Patients in the imiquimod group had an overall complete clearance rate of 55·0% (71/129) vs. a rate of 2·3% (3/130) for the vehicle group. There was a high rate of agreement between the clinical assessment and histological findings with respect to AK lesion clearance. At both 8-week post-treatment visits, the negative predictive value of the investigator assessment was 92·2% for clinical assessments vs. histological results.

Conclusions  A 4-week course of treatment with three times weekly dosing of imiquimod 5% cream, with a repeated course of treatment for those patients who fail to clear after the first course of treatment, is a safe and effective treatment for AK. The overall complete clearance rate (complete clearance after either course 1 or course 2) is comparable to the 16-week treatment regimen, while decreasing drug exposure to the patient and decreasing the overall treatment time.

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