Actinic Keratosis Clinical Trial
Official title:
Prospective, Randomized, Partly Blinded, in Part Placebo-controlled, Multicenter, Dose-finding Trial Exploring Safety, Tolerability and Efficacy of a Topical Resiquimod Gel in Patients With Multiple Actinic Keratosis Lesions
A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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