Patients suffering from actinic keratosis to be treated with PDT
Conditions
Sponsors
IDEA AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of actinic keratosis to be treated with PDT - affecting equal sized areas of both sides of the head - affecting at least 10% of the area of photo-exposure Aged 18-85 years Reliable method of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intraueterine-devices, sexual abstinence or vasectomised partner) Willing to obstain from excessive sun/UV exposure during the course of the study Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Other clinically relevant dermal or systemic diseases including malignancy Major hypertrophy of lesions Porphyria Topical treatment with 5-FU, cryotherapy, PDT, diclophenac sodium, and other less common treatments on the treatment area or systemic treatment within 3 months prior to screening Immunosuppressants within 2 weeks prior to screening Concomitant use of topical immunmodulators, other analgesics including topical NSAIDs, retinoids, antioxidants Known sensitisation to NSAIDs Photoallergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effect of IDEA-070 compared to placebo on pain and inflammation induced by PDT;Secondary Objective: Clearance rate Safety of IDEA-070;Primary end point(s): Endpoints related to and including the primary efficacy endpoints are: -Patient evaluation of pain using a 100 mm VAS, rated 3.0-3.5 h before PDT, immediately after PDT, 4 h after PDT (day 1), 24 h after PDT (day 2), on day 4, day 8, and day 28 -Investigator evaluation of inflammation using an aggregate (sum) score and corresponding subscores, evaluated 3.0-3.5 h before PDT, 4 h after PDT (day 1), 24 h after PDT (day 2), on day 4, day 8, and day 28 -The change of pain VAS from 3.0-3.5 hours prior to PDT, i.e. the difference “assessment value” – “3.0-3.5 hours prior to PDT”; primary efficacy endpoint for “assessment value” = “immediately post PDT until 24 h post PDT” -The change of aggregate (sum) score of inflammation from 3.0-3.5 hours prior to PDT, i.e. the difference “assessment value” – “3.0-3.5 hours prior to PDT”; primary efficacy endpoint for “assessment value” = “4 h post PDT until day 8” | — |
Countries
Germany
Outcome results
None listed