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Imiquimod 5% cream for the treatment of actinic keratosis: Results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology

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Abstract

Background

Increasing evidence suggests imiquimod may be a safe therapeutic option for the treatment of actinic keratosis (AK). The diagnosis and assessment of most AK lesions is made clinically, without histologic confirmation.

Objective

A phase III, randomized, double-blind, parallel group, vehicle-controlled study evaluated the efficacy of imiquimod 5% cream compared with vehicle in the treatment of AK lesions on the face and balding scalp including pretreatment and posttreatment biopsy specimens.

Methods

A total of 286 patients at 18 centers in 6 European countries with histologically confirmed AK were randomized to either imiquimod 5% cream or vehicle cream. Study cream was applied once per day, 3 days per week, for 16 weeks. Clearance of AK lesions was clinically and histologically assessed at an 8-week posttreatment visit.

Results

The complete clearance rate for the imiquimod group was 57.1% versus 2.2% for the vehicle group (P < .001). The partial clearance rate (≥75% reduction in baseline lesions) for the imiquimod group was 72.1% versus 4.3% for the vehicle group (P < .001). The most common side effects were erythema, scabbing/crusting, and erosions/ulceration. For the imiquimod group the incidence of severe erythema, scabbing/crusting, or erosions/ulceration was 30.6%, 29.9%, and 10.2%, respectively.

Conclusion

Imiquimod 5% cream used 3 times per week for 16 weeks is an effective treatment for AK. Clinical clearance was established by both clinical observation and histologic analysis.

Section snippets

Study population

Eligible patients were otherwise healthy men and women at least 18 years of age with 5 to 9 clinically diagnosed and histologically confirmed AK lesions located within a contiguous 25-cm2 treatment area on the face or balding scalp. The treatment area could not include both the face and balding scalp. Patients were to be excluded from the study if they had any condition in the treatment area that could be exacerbated by treatment with imiquimod 5% cream or that would impair the examination of

Study population

A total of 327 people were screened and 286 were enrolled. Violations of inclusion or exclusion criteria were the most common reasons for study ineligibility. Overall, 147 patients were randomized to treatment with imiquimod 5% cream and 139 patients were randomized to treatment with vehicle cream. Patient accountability is shown in Fig 1. There were no significant differences between treatment groups for age, sex, race, or Fitzpatrick skin type (Table II).

Efficacy

Imiquimod 5% cream was statistically

Discussion

The results from this study demonstrate that imiquimod 5% cream dosed once daily 3 times weekly for 16 weeks is an effective and well-tolerated treatment option for AK lesions on the face and scalp. These results confirm the results of previous studies that showed imiquimod 5% cream was an effective treatment for AK when dosed once daily 2 times weekly for 16 weeks. The benefits of treatment with topical imiquimod 5% cream included complete clearance or partial clearance (≥75% reduction in the

Acknowledgements

We would like to thank Scott W. McKane for statistical analysis and Amy L. Brown for manuscript preparation.

References (14)

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Supported by 3M Pharmaceuticals, St Paul, Minn.

Disclosure: Drs Szeimies, Gerritsen, Gupta, Ortonne, Serresi, and Alomar have received support from 3M Pharmaceuticals for performing clinical trials. Drs Gupta, Alomar, Ortonne, and Gerritsen have served as consultants and/or received honoraria from 3M Pharmaceuticals. Dr Szeimies is also a consultant for other companies that have and are developing treatments for actinic keratosis. Dr Bichel, Dr Lee, and Mr Fox are employees of 3M Pharmaceuticals.

Results have been presented in part at the 12th Congress of the European Academy of Dermatology and Venerology, Barcelona, Spain, October 15-18, 2003. Several abstracts and posters that contain the results presented in this manuscript were presented at the 62nd Annual Meeting of the American Academy of Dermatology, Washington, DC, February 6-11, 2004.

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