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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spirig Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01583816
First received: April 18, 2012
Last updated: December 14, 2015
Last verified: December 2015
  Purpose
A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions

Condition Intervention Phase
Actinic Keratosis
Drug: Resiquimod 0.03%
Drug: Resiquimod 0.01%
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spirig Pharma Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with partial clearance [ Time Frame: 8 weeks after a maximal treatment period of 8 weeks ] [ Designated as safety issue: No ]
  • Evaluation of systemic tolerability [hematology, blood chemistry, vital signs] [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 218
Study Start Date: May 2012
Study Completion Date: June 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583816

Locations
Germany
Hauttumorcentrum Charité (HTCC)
Berlin, Germany
Medizinisches Zentrum Bonn - Friedensplatz
Bonn, Germany
Hautzentrum
Düsseldorf, Germany
Johannes Wesling Klinikum Minden
Minden, Germany
KLINIKUM VEST GmbH Knappschaftskrankenhaus
Recklinghausen, Germany
Switzerland
Kantonsspital Aarau
Aarau, Switzerland
Universitätsspital Basel
Basel, Switzerland
Inselspital
Bern, Switzerland
Kantonsspital St.Gallen
St. Gallen, Switzerland
Universitaetsspital Zurich
Zurich, Switzerland
Sponsors and Collaborators
Spirig Pharma Ltd.
Investigators
Principal Investigator: Lars E French, MD University Clinic of Dermatology, Zurich
  More Information

Responsible Party: Spirig Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01583816     History of Changes
Other Study ID Numbers: SP848-AK-1101 
Study First Received: April 18, 2012
Last Updated: December 14, 2015
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Spirig Pharma Ltd.:
Actinic Keratosis
Resiquimod

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Neoplasms
Precancerous Conditions
Skin Diseases

ClinicalTrials.gov processed this record on April 27, 2016