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

A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Resiquimod 0.03%; Drug: placebo; Drug: Resiquimod 0.01%

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 Type: Interventional
• Enrollment (Actual): 218
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Hauttumorcentrum Charité (HTCC)
  • Bonn, Germany
    • Medizinisches Zentrum Bonn - Friedensplatz
  • Düsseldorf, Germany
    • Hautzentrum
  • Minden, Germany
    • Johannes Wesling Klinikum Minden
  • Recklinghausen, Germany
    • KLINIKUM VEST GmbH Knappschaftskrankenhaus
• Switzerland
  • Aarau, Switzerland
    • Kantonsspital Aarau
  • Basel, Switzerland
    • Universitatsspital Basel
  • Bern, Switzerland
    • Inselspital
  • St. Gallen, Switzerland
    • Kantonsspital St.Gallen
  • Zurich, Switzerland
    • UniversitaetsSpital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resiquimod Gel 0.03% or placebo; Resiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once	Drug: Resiquimod 0.03%; topical application; Drug: placebo; topical application
Experimental: Resiquimod or placebo; Once daily, 7x within 2 weeks, break of 8 weeks, cycle repeated once	Drug: Resiquimod 0.03%; topical application; Drug: placebo; topical application
Experimental: Resiquimod or vehicle; Once daily, 5x for 1 week, break of 8 weeks, cycle repeated once	Drug: Resiquimod 0.03%; topical application; Drug: placebo; topical application
Experimental: Resiquimod gel 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	Drug: Resiquimod 0.01%; topical application
Experimental: Resiquimod gel 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	Drug: Resiquimod 0.03%; topical application

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Spirig Pharma Ltd.
• Investigators: Principal Investigator: Lars E French, MD, University Clinic of Dermatology, Zurich

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 20, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Actinic Keratosis; Resiquimod
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: SP848-AK-1101