NCT01583816

Dose-finding, Safety, Efficacy Trial of Topical Resiquimod in Patients With Multiple Actinic Keratosis Lesions

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Spirig Pharma Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Resiquimod 0.03%	topical application
DRUG	Resiquimod 0.01%	topical application
DRUG	placebo	topical application

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-11-01
• Completion: 2014-06-01
• First posted: 2012-04-24
• Last updated: 2015-12-15

Locations

10 sites across 2 countries: Germany, Switzerland