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

Actinic Keratosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583816
• Other study ID #: SP848-AK-1101
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2012
• Last updated: December 14, 2015
• Start date: May 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Spirig Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: SwissmedicGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: June 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Resiquimod 0.03%
topical application
• Resiquimod 0.01%
topical application
• placebo
topical application

Locations

Country	Name	City	State
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
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Universitätsspital Basel	Basel
Switzerland	Inselspital	Bern
Switzerland	Kantonsspital St.Gallen	St. Gallen
Switzerland	Universitaetsspital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Spirig Pharma Ltd.

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation of adverse events (AEs) and serious adverse events (SAEs)		up to 24 weeks	Yes
Secondary	Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales		up to 24 weeks	Yes
Secondary	Number of patients with partial clearance		8 weeks after a maximal treatment period of 8 weeks	No
Secondary	Evaluation of systemic tolerability [hematology, blood chemistry, vital signs]		up to 24 weeks	Yes