search
Back to results

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

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Resiquimod 0.03%
Resiquimod 0.01%
placebo
Sponsored by
Spirig Pharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, Resiquimod

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hauttumorcentrum Charité (HTCC)
  • Medizinisches Zentrum Bonn - Friedensplatz
  • Hautzentrum
  • Johannes Wesling Klinikum Minden
  • KLINIKUM VEST GmbH Knappschaftskrankenhaus
  • Kantonsspital Aarau
  • Universitätsspital Basel
  • Inselspital
  • Kantonsspital St.Gallen
  • Universitaetsspital Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Resiquimod Gel 0.03% or placebo

Resiquimod or placebo

Resiquimod or vehicle

Resiquimod gel 0.01%

Resiquimod gel 0.03%

Arm Description

Resiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once

Once daily, 7x within 2 weeks, break of 8 weeks, cycle repeated once

Once daily, 5x for 1 week, break of 8 weeks, cycle repeated once

Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up

Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of adverse events (AEs) and serious adverse events (SAEs)
Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales
Number of patients with partial clearance
Evaluation of systemic tolerability [hematology, blood chemistry, vital signs]

Full Information

First Posted
April 18, 2012
Last Updated
December 14, 2015
Sponsor
Spirig Pharma Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01583816
Brief Title
Dose-finding, Safety, Efficacy Trial of Topical Resiquimod in Patients With Multiple Actinic Keratosis Lesions
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spirig Pharma Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic Keratosis, Resiquimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resiquimod Gel 0.03% or placebo
Arm Type
Experimental
Arm Description
Resiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once
Arm Title
Resiquimod or placebo
Arm Type
Experimental
Arm Description
Once daily, 7x within 2 weeks, break of 8 weeks, cycle repeated once
Arm Title
Resiquimod or vehicle
Arm Type
Experimental
Arm Description
Once daily, 5x for 1 week, break of 8 weeks, cycle repeated once
Arm Title
Resiquimod gel 0.01%
Arm Type
Experimental
Arm Description
Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up
Arm Title
Resiquimod gel 0.03%
Arm Type
Experimental
Arm Description
Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up
Intervention Type
Drug
Intervention Name(s)
Resiquimod 0.03%
Intervention Description
topical application
Intervention Type
Drug
Intervention Name(s)
Resiquimod 0.01%
Intervention Description
topical application
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
topical application
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Evaluation of adverse events (AEs) and serious adverse events (SAEs)
Time Frame
up to 24 weeks
Title
Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales
Time Frame
up to 24 weeks
Title
Number of patients with partial clearance
Time Frame
8 weeks after a maximal treatment period of 8 weeks
Title
Evaluation of systemic tolerability [hematology, blood chemistry, vital signs]
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars E French, MD
Organizational Affiliation
University Clinic of Dermatology, Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hauttumorcentrum Charité (HTCC)
City
Berlin
Country
Germany
Facility Name
Medizinisches Zentrum Bonn - Friedensplatz
City
Bonn
Country
Germany
Facility Name
Hautzentrum
City
Düsseldorf
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
Country
Germany
Facility Name
KLINIKUM VEST GmbH Knappschaftskrankenhaus
City
Recklinghausen
Country
Germany
Facility Name
Kantonsspital Aarau
City
Aarau
Country
Switzerland
Facility Name
Universitätsspital Basel
City
Basel
Country
Switzerland
Facility Name
Inselspital
City
Bern
Country
Switzerland
Facility Name
Kantonsspital St.Gallen
City
St. Gallen
Country
Switzerland
Facility Name
Universitaetsspital Zurich
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs