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

NCT ID: NCT01583816

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-06-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Actinic Keratosis

Keywords

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Actinic Keratosis Resiquimod

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Resiquimod 0.03%

Intervention Type DRUG

topical application

placebo

Intervention Type DRUG

topical application

Resiquimod or placebo

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

Group Type EXPERIMENTAL

Resiquimod 0.03%

Intervention Type DRUG

topical application

placebo

Intervention Type DRUG

topical application

Resiquimod or vehicle

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

Group Type EXPERIMENTAL

Resiquimod 0.03%

Intervention Type DRUG

topical application

placebo

Intervention Type DRUG

topical application

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

Group Type EXPERIMENTAL

Resiquimod 0.01%

Intervention Type DRUG

topical application

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

Group Type EXPERIMENTAL

Resiquimod 0.03%

Intervention Type DRUG

topical application

Interventions

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Resiquimod 0.03%

topical application

Intervention Type DRUG

Resiquimod 0.01%

topical application

Intervention Type DRUG

placebo

topical application

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spirig Pharma Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars E French, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinic of Dermatology, Zurich

Locations

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Hauttumorcentrum Charité (HTCC)

Berlin, , Germany

Site Status

Medizinisches Zentrum Bonn - Friedensplatz

Bonn, , Germany

Site Status

Hautzentrum

Düsseldorf, , Germany

Site Status

Johannes Wesling Klinikum Minden

Minden, , Germany

Site Status

KLINIKUM VEST GmbH Knappschaftskrankenhaus

Recklinghausen, , Germany

Site Status

Kantonsspital Aarau

Aarau, , Switzerland

Site Status

Universitätsspital Basel

Basel, , Switzerland

Site Status

Inselspital

Bern, , Switzerland

Site Status

Kantonsspital St.Gallen

Sankt Gallen, , Switzerland

Site Status

Universitaetsspital Zurich

Zurich, , Switzerland

Site Status

Countries

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Germany Switzerland

Other Identifiers

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SP848-AK-1101

Identifier Type: -

Identifier Source: org_study_id