Actinic Keratosis on the Face or Scalp
Conditions
Brief summary
Percent change from baseline in lesion count at Day 57
Detailed description
Proportion of patients with PC at Day 57, defined as ≥75% clearance in the TF at Day 57, Proportion of patients with CC at Day 57, defined as 100% clearance in the TF at Day 57, Proportion of patients with PC by Day 113, defined as 100% clearance in the TF at Day 57 or, for patients receiving a second treatment course, ≥75% clearance at Day 113, Proportion of patients with CC by Day 113, defined as 100% clearance in the TF at Day 57 or, for patients receiving a second treatment course, 100% clearance at Day 113
Interventions
DRUGTIRBANIBULIN
DRUGPlacebo of the new presentation of 350 mg/sachet drug product (hereafter referred as vehicle) is a smooth
DRUGcreamy white to off-white ointment free from foreign particles
DRUGpacked intact and
properly sealed containing the same qualitative composition as the active product but without the active substance. The vehicle will be provided in a single-use packets to contain 350 mg of
drug product.
Sponsors
Almirall S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in lesion count at Day 57 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with PC at Day 57, defined as ≥75% clearance in the TF at Day 57, Proportion of patients with CC at Day 57, defined as 100% clearance in the TF at Day 57, Proportion of patients with PC by Day 113, defined as 100% clearance in the TF at Day 57 or, for patients receiving a second treatment course, ≥75% clearance at Day 113, Proportion of patients with CC by Day 113, defined as 100% clearance in the TF at Day 57 or, for patients receiving a second treatment course, 100% clearance at Day 113 | — |
Countries
Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed