Actinic Cheilitis
Conditions
Keywords
Actinic cheilitis, Imiquimod 5%, Photodynamic therapy
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.
Interventions
DRUGImiquimod 5%
Imiquimod 5% cream used three days a week for 4 weeks
PROCEDUREPhotodynamic therapy
Photodynamic therapy involves applying Metvix cream to the affected area followed by illumination. It will be done twice during the study at a 2 week interval.
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical and pathological complete cure rates. | 3 and 12 months after therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical, safety, epidemiological and histopathological data | post-treatment | Through collecting patient data and post-treatment biopsy |
Countries
Norway
Outcome results
None listed