NCT01583816

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2012

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

April 18, 2012

Last Update Submit

December 14, 2015

Conditions

Actinic Keratosis

Keywords

Actinic KeratosisResiquimod

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Evaluation of adverse events (AEs) and serious adverse events (SAEs)

    up to 24 weeks

  • Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales

    up to 24 weeks

  • Number of patients with partial clearance

    8 weeks after a maximal treatment period of 8 weeks

  • Evaluation of systemic tolerability [hematology, blood chemistry, vital signs]

    up to 24 weeks

Study Arms (5)

Resiquimod Gel 0.03% or placebo

EXPERIMENTAL

Resiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once

Drug: Resiquimod 0.03%Drug: placebo

Resiquimod or placebo

EXPERIMENTAL

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

Drug: Resiquimod 0.03%Drug: placebo

Resiquimod or vehicle

EXPERIMENTAL

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

Drug: Resiquimod 0.03%Drug: placebo

Resiquimod gel 0.01%

EXPERIMENTAL

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%

Resiquimod gel 0.03%

EXPERIMENTAL

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%

Interventions

Resiquimod 0.03%DRUG

topical application

Resiquimod Gel 0.03% or placeboResiquimod gel 0.03%Resiquimod or placeboResiquimod or vehicle
Resiquimod 0.01%DRUG

topical application

Resiquimod gel 0.01%
placeboDRUG

topical application

Resiquimod Gel 0.03% or placeboResiquimod or placeboResiquimod or vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hauttumorcentrum Charité (HTCC)

Berlin, Germany

Location

Medizinisches Zentrum Bonn - Friedensplatz

Bonn, Germany

Location

Hautzentrum

Düsseldorf, Germany

Location

Johannes Wesling Klinikum Minden

Minden, Germany

Location

KLINIKUM VEST GmbH Knappschaftskrankenhaus

Recklinghausen, Germany

Location

Kantonsspital Aarau

Aarau, Switzerland

Location

Universitätsspital Basel

Basel, Switzerland

Location

Inselspital

Bern, Switzerland

Location

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Location

Universitaetsspital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lars E French, MD

    University Clinic of Dermatology, Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 24, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2013

Study Completion

June 1, 2014

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations

DE(5)CH(5)