Actinic Keratosis Clinical Trial
Official title:
Actinic Keratoses and 5% Topical Imiquimod: Lessons to Learn From a Prospective Non-Interventional Study by 93 Office-based Dermatologists
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.
Status | Completed |
Enrollment | 463 |
Est. completion date | May 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - no study specific, just following the label of imiquimod Exclusion Criteria: - no study specific, just following the label of Imiquimod |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federal University Teaching Hospital, Feldkirch, Austria | MEDA Pharma GmbH & Co. KG |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Management of the actic keratosis patient routinely treated with Imiquimod by non-hospital based dermatologists | Information about the typical imiquimod patient, therapeutic course, treatment decisions and satisfaction of patients/dermatologists. | 12 weeks | No |
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