Actinic Keratosis
Conditions
Keywords
Actinic Keratosis, AK, NMSC, Combination
Brief summary
The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).
Detailed description
To investigate as primary objective: * Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion; To investigate as secondary objective: * Superiority to LAS106521 * Improvement of treated lesions (lesion response) * Assessment of tolerability and safety by physicians global assessment score (PGA, PGT) * Patient's assessment of tolerability and efficacy and patient's compliance
Sponsors
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Have at least 4 but not more than 10 clinically confirmed AK target lesions of mild to moderate intensity within the face/forehead or bald scalp (excluding eyelids, lips, and mucosa), i.e. actinic keratosis grade I and II according to Olsen EA et al. 1991 * Woman of childbearing potential are allowed to participate in this study only if they use a highly effective method of contraception Main
Exclusion criteria
* Have received effective treatment of AK in the three months preceding this clinical trial * Have known hypersensitivity to LAS41005 or LAS106521 * Have currently other malignant or benign tumors of the skin within the treatment area (e.g. malignant melanoma, basal cell carcinoma, squamous cell carcinoma) * Patient's taking phenytoin * Show cornu cutaneum like alterations of the skin in the face or the bald scalp (target area)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histological status of AK target lesion | Day 140 |
Countries
Germany
Outcome results
None listed