Actinic Keratosis
Conditions
Keywords
Actinic Keratosis, Resiquimod
Brief summary
A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions
Detailed description
Prospective, randomized, partly blinded, in part placebo-controlled, multicenter dose-finding trial with patients suffering from AK. Patients were observed for efficacy, local tolerability and safety. A total of 14 sites in Switzerland and Germany enrolled male and female patients over 18 years of age with clinically diagnosed AK lesions Patients were randomized to receive resiquimod gel (Treatment Arms 1, 2, 3, 4, or 5) or matching vehicle (Treatment Arms 1-Pla, 2-Pla, or 3-Pla): Treatment Arms 1, 2 and 3: The patient was randomly assigned to one of three treatment groups and within each group there was one randomly assigned placebo patient for every two treatment patients (parallel-group randomization; 2:1 active vs placebo). Treatment Arms 4 and 5: The patient was randomly assigned to one of two treatment groups (parallel-group randomization, 1:1).
Interventions
DRUGResiquimod 0.03%
topical application
DRUGResiquimod 0.01%
topical application
DRUGplacebo
topical application
Sponsors
Spirig Pharma Ltd.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Male or nonpregnant, nonlactating female, ≥18 years * A minimum of 2 clinically diagnosed AK-lesions within a defined area (25 cm2 contiguous treatment area). One AK-lesion must have a diameter of at least 6 mm (indicator lesion) * AK-lesions on balding scalp, forehead or face
Exclusion criteria
* Known allergy or hypersensitivity to any of the trial gel ingredients * Dermatological disease or condition that might be exacerbated by resiquimod gel treatment or may impair trial assessments * Evidence of unstable or uncontrolled clinically significant medical conditions, active infection, immunosuppression or systemic cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with complete clinical clearance in the treated area at the end of trial | 8 weeks after a maximal treatment period of 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of adverse events (AEs) and serious adverse events (SAEs) | up to 24 weeks |
| Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales | up to 24 weeks |
| Number of patients with partial clearance | 8 weeks after a maximal treatment period of 8 weeks |
| Evaluation of systemic tolerability [hematology, blood chemistry, vital signs] | up to 24 weeks |
Countries
Germany, Switzerland
Outcome results
None listed