Imiquimod and Actinic Keratoses: an Observational Study

NCT01151956 | Completed DMC

• 1 other identifier: OBIMQ465-AK-08
• Study Type: observational
• Target: 463
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Actinic Keratosis

Keywords

observational study; actinic keratosis; imiquimod

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with actinic keratoses who are routinely treated with topical 5% Imiquimod by non-hospital based dermatologists

You may qualify if:

• no study specific, just following the label of imiquimod

You may not qualify if:

• no study specific, just following the label of Imiquimod

Sponsors & Collaborators

• Federal University Teaching Hospital, Feldkirch, Austria: lead
• MEDA Pharma GmbH & Co. KG: collaborator

Related Publications (1)

• Strohal R, Kerl H, Schuster L. Treatment of actinic keratoses with 5% topical imiquimod: a multicenter prospective observational study from 93 Austrian office-based dermatologists. J Drugs Dermatol. 2012 May;11(5):574-8.

  PMID: 22527424 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert Strohal, AssocProfDr

  Federal University Teaching Hospital of Feldkirch, Dept. of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 29, 2010
• Study Start: May 1, 2008
• Study Completion: May 1, 2009
• Last Updated: July 1, 2010

Record last verified: 2008-04