Clinical trial NCT01583816: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Resiquimod
Lead sponsor: Spirig Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2012-04-24
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Number of patients with complete clinical clearance in the treated area at the end of trial
timeFrame: 8 weeks after a maximal treatment period of 8 weeks
Secondary outcomes:
measure: Evaluation of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: up to 24 weeks
measure: Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales
timeFrame: up to 24 weeks
measure: Number of patients with partial clearance
timeFrame: 8 weeks after a maximal treatment period of 8 weeks
measure: Evaluation of systemic tolerability [hematology, blood chemistry, vital signs]
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hauttumorcentrum Charité (HTCC)
city: Bonn
country: Germany
facility: Medizinisches Zentrum Bonn - Friedensplatz
city: Düsseldorf
country: Germany
facility: Hautzentrum
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Recklinghausen
country: Germany
facility: KLINIKUM VEST GmbH Knappschaftskrankenhaus
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Zurich
country: Switzerland
facility: Universitaetsspital Zurich
Study officials:
affiliation: University Clinic of Dermatology, Zurich
name: Lars E French, MD
role: PRINCIPAL_INVESTIGATOR
References: