Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

February 21, 2025 updated by: LEO Pharma

Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate 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)

220

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

  • United States
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Gwinnett 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 full balding scalp.
  • Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp

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
Other: Part 1: LEO 43204
Open-label, dose escalation, 2 days treatment
Drug: LEO 43204
Active Comparator: Part 2: LEO 43204 x dose
X dose for 2 days treatment
Drug: LEO 43204
Active Comparator: Part 2: LEO 43204 Y dose
Y dose for 2 days treatment
Drug: LEO 43204
Placebo Comparator: Part 2: Placebo
Placebo for 2 days treatment
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
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) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants experiencing a DLT.

A DLT was defined as:

  • Erosion/ulceration Grade 4 on the Local Skin Response (LSR) scale
  • Other clinically relevant signs or symptoms observed, which the International Co-ordinating Investigator judges to be counted as a DLT.

The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are 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) Lesion Count
Time Frame: From baseline to Week 8
Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) in the selected treatment area.
From baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 2: Participants With Complete Clearance of AKs
Time Frame: From baseline to Week 8
Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in AK count.
From baseline to Week 8
Part 2: Participants With Partial Clearance of AKs
Time Frame: From baseline to Week 8
Partial clearance of AKs at Week 8 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: Jonathan Weiss, MD, Gwinnett Clinical Research Center, Inc.

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)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimated)

April 1, 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

  • LP0084-1014
  • 2014-000037-23 (EudraCT Number)

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.

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