Imiquimod and Actinic Keratoses: an Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01151956
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : July 1, 2010
MEDA Pharma GmbH & Co. KG
Information provided by:
Federal University Teaching Hospital, Feldkirch, Austria

Brief Summary:

Objective: To show how dermatologists treat actinic keratoses with imiquimod 5% cream in their daily clinical routine.

Design: Prospective, non-interventional, observational, multicenter clinical study.

Setting: Offices of 93 non hospital based Austrian dermatologists. Participants: Inclusion of the 463 patients into the study was solely based on the treatment decision of the dermatologist and the patients will.

Interventions: No specific interventions except suggested time points of visits with pre-defined documentation forms. The therapy of actinic keratoses followed the imiquimod label (3x/week for 4 weeks, 4 therapy free weeks, another 3x/week for 4 weeks, when needed) Main outcome measure: Information about the typical imiquimod patient, therapeutic course, treatment decisions, safety and satisfaction of patients/dermatologists.

Condition or disease
Actinic Keratosis

Detailed Description:

DESIGN AND STUDY POPULATION The present study was a prospective, open label, non interventional clinical study precisely documenting the routine therapy of AK with imiquimod 5% cream. According to Austrian regulations, for an observational study where medication follows the label of the drug it is not necessary to seek approval from the federal ethic committee. Except the presence of multiple AK there were no further rules to include the patient into the study. Following the dermatologists decision and the patients will, 463 patients were treated in the offices of 93 non hospital based Austrian dermatologists. There were no further interventions except recommended time points of visits documented with pre-defined forms. Imiquimod therapy followed the label. Patients applied imiquimod at home 3x/week (typically Monday, Wednesday and Thursday) for 4 weeks, followed by 4 therapy free weeks and another 3x/week 4 weeks therapeutic course, when needed. Recommended visits (V) were: V1 baseline, week 0; V2, week 4 (end of the first treatment cycle); V3, week 8 (decision point for the need of a second treatment course); V4, week 16 (for those receiving a second treatment course). Additional unplanned visits (VX) were possible and also documented.

STUDY PROCEDURES At baseline patients characteristics, i.e. sex, age, size and weight were documented together with the information who referred the patient to the dermatologist. Next, the patient skin cancer family history and the AK history including the time of the first presentation as well as former therapies and their success were asked. This was followed by a dermatological examination which defined the numbers of AK lesions, their location and the nature as well as intensity of initial skin signs (erosion, crusting, erythema, ulceration, swelling, others, graded as no, mild, moderate, severe). Before the start of the therapy, patients were informed about the typical imiquimod skin reactions by a set of pictures and a brochure. In addition, all patients got a treatment plan showing the different phases of the therapy and the time points when imiquimod should be applied. Within this plan patients also had the possibility to document their imiquimod use. Also at baseline, potential systemic and local co-medications were documented.

At all following visits, nature and intensity of Imiquimod related skin responses potential adverse events and pre-final termination of the study were acknowledged. Decisions by the dermatologists were documented as (i) nature of the topical post imiquimod treatment of therapeutic skin reactions (V2, V3, V4, VX), (ii) initiation of a second therapeutic course, or character of the alternative therapy (V3) as well as (iii) full clearing of all lesions, or number of remaining lesions (V3, V4). At VX the dermatologist reaction to this unplanned visit was asked (no consequences, temporary discontinuation of the therapy - how long, topical treatment of the therapy related skin symptoms, or, pre-final termination of the therapy). At the end of the study, reasons for a potential pre-final termination (lack of efficacy, patients wish, adverse events, others), the kind of subsequent therapy for remaining AK lesions, satisfaction of the dermatologist with the efficacy, tolerability and the cosmetic outcome of the imiquimod therapy as well as patients general and specific satisfaction with the cosmetic outcome and his estimation about the therapy success including his grade of relief with the solved problem were delineated.

Study Type : Observational
Actual Enrollment : 463 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Actinic Keratoses and 5% Topical Imiquimod: Lessons to Learn From a Prospective Non-Interventional Study by 93 Office-based Dermatologists
Study Start Date : May 2008
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod
U.S. FDA Resources

actinic keratosis patients
patients who see their non-hospital based dermatologist, because of multiple actinic keratoses and who are then routinely treated with topical 5% Imiquimod

Primary Outcome Measures :
  1. Management of the actic keratosis patient routinely treated with Imiquimod by non-hospital based dermatologists [ Time Frame: 12 weeks ]
    Information about the typical imiquimod patient, therapeutic course, treatment decisions and satisfaction of patients/dermatologists.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with actinic keratoses who are routinely treated with topical 5% Imiquimod by non-hospital based dermatologists

Inclusion Criteria:

  • no study specific, just following the label of imiquimod

Exclusion Criteria:

  • no study specific, just following the label of Imiquimod

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01151956

Sponsors and Collaborators
Federal University Teaching Hospital, Feldkirch, Austria
MEDA Pharma GmbH & Co. KG
Principal Investigator: Robert Strohal, AssocProfDr Federal University Teaching Hospital of Feldkirch, Dept. of Dermatology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Lydia Schuster, Meda Pharma Austria Identifier: NCT01151956     History of Changes
Other Study ID Numbers: OBIMQ465-AK-08
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: April 2008

Keywords provided by Federal University Teaching Hospital, Feldkirch, Austria:
observational study
actinic keratosis

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers