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

Phase 2

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Resiquimod 0.03%; Drug: Resiquimod 0.01%; Drug: placebo

• Registration Number: NCT01583816
• Lead Sponsor: Spirig Pharma Ltd.

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).

Study Timeline

• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-24
• Study Start: 2012-05
• Primary Completion: 2013-11
• Study Completion: 2014-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resiquimod Gel 0.03% or placebo	placebo	Resiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once
Resiquimod or placebo	Resiquimod 0.03%	Once daily, 7x within 2 weeks, break of 8 weeks, cycle repeated once
Resiquimod or placebo	placebo	Once daily, 7x within 2 weeks, break of 8 weeks, cycle repeated once
Resiquimod or vehicle	Resiquimod 0.03%	Once daily, 5x for 1 week, break of 8 weeks, cycle repeated once
Resiquimod Gel 0.03% or placebo	Resiquimod 0.03%	Resiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once
Resiquimod or vehicle	placebo	Once daily, 5x for 1 week, break of 8 weeks, cycle repeated once
Resiquimod gel 0.01%	Resiquimod 0.01%	Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up
Resiquimod gel 0.03%	Resiquimod 0.03%	Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

KLINIKUM VEST GmbH Knappschaftskrankenhaus; 🇩🇪 Recklinghausen, Germany

Johannes Wesling Klinikum Minden; 🇩🇪 Minden, Germany

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Kantonsspital St.Gallen; 🇨🇭 St. Gallen, Switzerland

Inselspital; 🇨🇭 Bern, Switzerland

Hautzentrum; 🇩🇪 Düsseldorf, Germany

Hauttumorcentrum Charité (HTCC); 🇩🇪 Berlin, Germany

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Universitaetsspital Zurich; 🇨🇭 Zurich, Switzerland

Medizinisches Zentrum Bonn - Friedensplatz; 🇩🇪 Bonn, Germany