Actinic Keratosis (AK)
Conditions
Brief summary
This is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.
Detailed description
All subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or scalp. Eligible subjects will be randomised in a 1:1 ratio to the following treatment groups: * Treatment Group A: Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days. * Treatment Group B: Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.
Interventions
Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.
Diclofenac sodium gel 3% Solaraze® applied on the selected treatment area, twice daily for 90 days.
Sponsors
LEO Pharma
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
1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures 2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp
Exclusion criteria
1\. Location of the selected treatment area: * on the periorbital skin * on the perioral skin/around the nostrils * within 5 cm of an incompletely healed wound * within 10 cm of a suspected BCC or SCC or other neoplasia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete clearance of all AKs | 11 Months | Complete clearance of all AKs in the treatment field at Week 8 for ingenol mebutate gel 0.015% and Week 17 for diclofenac sodium gel 3% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete clearance of all AKs at Week 17 | 11 Months | As secondary response criteria, complete clearance at Week 17 for diclofenac sodium gel 3% will be compared with complete clearance in the ingenol mebutate 0.015% group. |
Countries
Germany
Outcome results
None listed