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Dose-finding Trial Exploring Safety, Tolerability and Efficacy of a Topical Resiquimod Gel in Patients With Multiple Actinic Keratosis Lesions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spirig Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01583816
First received: April 18, 2012
Last updated: October 24, 2013
Last verified: October 2013
  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
Drug: Placebo / Vehicle
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 ]

Estimated Enrollment: 208
Study Start Date: May 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resiquimod Gel Drug: Resiquimod
0.03% Resiquimod Topical Gel
Placebo Comparator: Placebo Gel Drug: Placebo / Vehicle
Placebo Topical Gel
Experimental: Resiquimod Gel - BioEP - 1 Drug: Resiquimod
0.01% Resiquimod Topical Gel
Experimental: Resiquimod Gel - BioEP - 2 Drug: Resiquimod
0.03% Resiquimod Topical Gel

  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

No publications provided

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: October 24, 2013
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 November 25, 2014