Brief Title
Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy
Official Title
Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis
Brief Summary
Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to
compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data,
histology (skin analysis), epidemiological data and follow-up data.
Detailed Description
Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis.
Histological, efficacy, epidemiological and clinical data will be collected.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
clinical and pathological complete cure rates.
Secondary Outcome
clinical, safety, epidemiological and histopathological data
Condition
Actinic Cheilitis
Intervention
Imiquimod 5%
Study Arms / Comparison Groups
Imiquimod 5%
Description: Patients randomized to this arm will receive treatment with imiquimod 5%
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
53
Start Date
March 2009
Completion Date
November 2013
Primary Completion Date
March 2013
Eligibility Criteria
Inclusion Criteria:
- Clinical findings of actinic cheilitis.
- Histological findings demonstrating epithelial changes equal to or greater than mild
epithelial dysplasia in severity (mild - moderate - severe).
- Age above 18.
- Willingness to take post-treatment biopsy.
Exclusion Criteria:
- Disorders predisposing to photosensitivity (porphyria, SLE).
- Pregnancy or nursing.
- Known allergy to any excipients in the study creams.
- prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and
curettage.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Stein H Sundstrøm, PhD, ,
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT00849992
Organization ID
20115
Responsible Party
Sponsor
Study Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
Study Sponsor
Stein H Sundstrøm, PhD, Principal Investigator, St. Olavs Hospital
Verification Date
May 2017