Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

February 21, 2025 updated by: LEO Pharma

Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days

Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2G 1B1
        • Kirk Barber Research
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Enverus Medical
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • Skin Care Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Winnipeg Clinic Dermatology Research
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • Ultranova Skincare
      • Hamilton, Ontario, Canada, L8N 1V6
        • Dermatrials Research Incorporated
      • London, Ontario, Canada, N6A 3H7
        • The Guenther Dermatology Research Centre
      • Peterborough, Ontario, Canada, K9J 1Z2
        • Skin Centre for Dermatology
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Omni Dermatology
    • California
      • Lomita, California, United States, 90717
        • Torrance Clinical Research Institute Inc.
      • San Diego, California, United States, 92121
        • Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Dermatology Associates and Research
      • Ormond Beach, Florida, United States, 32174
        • Leavitt Medical Associates of Florida
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic, Inc.
      • Evansville, Indiana, United States, 47714
        • Hudson Dermatology, LLC
      • Plainfield, Indiana, United States, 46168
        • Indiana Clinical Trials Center
    • Maryland
      • Rockville, Maryland, United States, 20850
        • DermAssociates, PC
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
    • New Jersey
      • Verona, New Jersey, United States, 07044
        • The Dermatology Group, P.C.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Pflugerville, Texas, United States, 78660
        • Pflugerville Dermatology Clinical Research Center, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm
  • Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk

Exclusion Criteria:

  • Location of the treatment area

    • within 5 cm of an incompletely healed wound
    • within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
  • Prior treatment with ingenol mebutate gel on the treatment area

  • Lesions in the treatment areas that have:

    • atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
    • recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LEO 43204
Open-label, dose-escalation, 2-day treatment
Drug: LEO 43204
Experimental: LEO 43204 Dose 0.1%
LEO 43204 dose 0.1% once daily for two consecutive days
Drug: LEO 43204
Experimental: LEO 43204 Dose 0.075%
LEO 43204 dose 0.075% once daily for two days
Drug: LEO 43204
Placebo Comparator: Placebo
Placebo once daily for two days
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
Time Frame: From Day 1 up to and including Day 8

The number participants experiencing a DLT was used to identify the maximum tolerated dose(MTD) levels of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level at which less than 4 out of 12 participants experienced a DLT.

A DLT was defined as one or more of the following three LSRs:

  • Crusting Grade 4
  • Erosion/Ulceration Grade 4
  • Vesiculation/Pustulation Grade 4

or two or more of the following five LSRs:

  • Crusting Grade 3
  • Swelling Grade 4
  • Erosion/Ulceration Grade 3
  • Vesiculation/Pustulation Grade 3

or other clinically relevant signs or symptoms observed, which the Investigator judged to be counted as a DLT.

The LSRs consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category was given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.
From Day 1 up to and including Day 8
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count
Time Frame: From baseline to Week 8
Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.
From baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])
Time Frame: From baseline to Week 8
Complete clearance was defined as a 100% reduction from baseline in AK count.
From baseline to Week 8
Part 2: Participants With Partial Clearance of AKs (LOCF)
Time Frame: From baseline to Week 8
Partial clearance was defined as at least 75% reduction from baseline in AK count.
From baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Gary Goldenberg, MD, Mount Sinai School of Medicine, Dermatology Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 18, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimated)

April 22, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0084-1015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Actinic Keratosis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe