Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively

February 21, 2025 updated by: LEO Pharma

Safety of LEO 43204 0.018%, 0.037% and 0.1% for Actinic Keratosis Applied Once Daily for Three Consecutive Days on Face/Chest, Scalp and Trunk/Extremities, Respectively

The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Phase 2

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
    • New York
      • Smithtown, New York, United States, 11787
        • Long Island Skin Cancer and Dermatologic Surgery

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:

Subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:

  • The full face
  • The full balding scalp
  • A contiguous area of approximately 250 cm2 on trunk or extremities

Exclusion Criteria:

Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.

Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.

Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months

Lesions in the treatment area that have: atypical clinical appearance (e.g. 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LEO 43204, 0.018% once daily for 3 days
Drug: LEO 43204
Treatment of actinic keratosis
Experimental: LEO 43204, 0.037% once daily for 3 days
Drug: LEO 43204
Treatment of actinic keratosis
Experimental: LEO 43204, 0.1% once daily for 3 days
Drug: LEO 43204
Treatment of actinic keratosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)
Time Frame: 8 days / From baseline (Day 1) to Day 8

For face/chest, 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:

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

For scalp a DLT was defined as erosion/ulceration Grade 4

For trunk/extremities 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 four LSRs:

  • Crusting Grade 3
  • Swelling Grade 4
  • Erosion/Ulceration Grade 3
  • Vesiculation/Pustulation Grade 3
8 days / From baseline (Day 1) to Day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Time Frame: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8
The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at baseline (Day 1), Week 4, and Week 8. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Time Frame: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8.
4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Percentage of Participants With Complete Clearance of AKs
Time Frame: 8 weeks
Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
8 weeks

Collaborators and Investigators

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

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Daniel M Siegel, MD, Long Island Skin Cancer and Dermatologic Surgery

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.

General Publications

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

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimated)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0084-1148

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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