Treatment of Actinic Keratoses With 5% Topical Imiquimod: A Multicenter Prospective Observational Study from 93 Austrian Office-based Dermatologists
May 2012 | Volume 11 | Issue 5 | Original Article | 574 | Copyright © 2012
Background: While randomized, controlled trials have generated information about the safety and efficacy of imiquimod 5% cream in
the treatment of actinic keratosis, still very little is known about the challenges and pitfalls of this therapy in the daily clinical routine.
Objective: To mirror the full picture of the actinic keratosis imiquimod routine therapy, ie, patient profile, in-therapy decisions, tolerability, and satisfaction.
Methods: The present observational, multicenter study included 463 patients from the offices of 93 non-hospital based Austrian dermatologists. Inclusion was solely based on the treatment decision of the dermatologist and the patient's will to participate. There were no specific interventions except suggested time points of visits with pre-defined documentation forms.
Results: The typical actinic keratosis patient was a male, aged 74 years, with a disease history of 5.7±5.3 years, who presented with 8.4±8.0 multiple pre-treated lesions at the face. More than 95% of the patients developed therapeutic skin responses (dominated by erythema and crusting), which led to a significant reduction of lesions from baseline to the end of the therapy. Notably, one-third of those patients prone to a second therapeutic course were submitted to another form of treatment. Post-imiquimod therapy comprised of antibiotic creams, topical steroids, and numerous emollients. Patients and dermatologists reported high satisfaction with the therapy including the cosmetic outcome.
Conclusion: Our data show the high need for experience at the dermatologist side and information at the patient side. Moreover, the method of treatment for imiquimod-related skin reactions definitively asks for standardization.
The study was registered at ClinicalTrials.gov (NCT01151956). Decision by ClinicalTrials.gov: Federal University Teaching Hospital, Feldkirch, Austria Protocol Record OBIMQ465-AK-08, Imiquimod and actinic keratoses: an observational study.
J Drugs Dermatol. 2012;11(5):574-578.
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Therapy of actinic keratosis (AK) using imiquimod 5% cream (Aldara, MEDA Pharmaceuticals, Somerset, NJ) was approved in the United States and European Union in 2005 and 2006, respectively. Despite the initial dosage recommendation of 2 times per week for 16 weeks, 1,2 a series of clinical studies 3-6 has led to a shorter treatment period: 3 times per week for 4 weeks, followed by a 4-week therapy-free interval. Eight weeks after the initiation of the therapy, the physician was asked to determine the necessity of a second treatment course of 3 times per week for 4 weeks.
While randomized controlled trials seemingly have generated information about the safety and efficacy of imiquimod 5% cream in the treatment of AK, still very little is known about important aspects of the therapy in the daily clinical routine, ie, the profile of the typical AK imiquimod patient; the way dermatologists define and handle imiquimod skin reactions; questions and fears of the patient; decision criteria for a second treatment course; and finally, patients' and dermatologists' satisfaction with the therapy. In order to bring to light to these different aspects and examine extensive practice treatment experiences, we designed a prospective, observational study with predefined forms to document suggested visits. There were no recommended interventions except the labeled use of imiquimod 5% cream to treat patients with actinic keratosis. In this context, it is important to emphasize that the goal of the study was definitely not to reiterate the already known efficacy profile of imiquimod in patients with AK, but to mirror the full picture of an AK imiquimod routine clinical therapy in the offices of 93 non-hospital based Austrian dermatologists.