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

Spirig Pharma Ltd.218 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

218

Conditions

Actinic Keratosis

Interventions

Resiquimod 0.03%DRUG

topical application

Resiquimod 0.01%DRUG

topical application

placeboDRUG

topical application

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Hauttumorcentrum Charité (HTCC)

Berlin, Germany

Medizinisches Zentrum Bonn - Friedensplatz

Bonn, Germany

Hautzentrum

Düsseldorf, Germany

Johannes Wesling Klinikum Minden

Minden, Germany

Outcomes

Primary Outcomes

Number of patients with complete clinical clearance in the treated area at the end of trial

Time frame: 8 weeks after a maximal treatment period of 8 weeks

Secondary Outcomes

Evaluation of adverse events (AEs) and serious adverse events (SAEs)

Time frame: up to 24 weeks

Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales

Time frame: up to 24 weeks

Number of patients with partial clearance

Time frame: 8 weeks after a maximal treatment period of 8 weeks

Evaluation of systemic tolerability [hematology, blood chemistry, vital signs]

Time frame: up to 24 weeks

Data from ClinicalTrials.gov

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