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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

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LEO 43204
Placebo
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Omni Dermatology
  • Torrance Clinical Research Institute Inc.
  • Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
  • Dermatology Associates and Research
  • Leavitt Medical Associates of Florida
  • Deaconess Clinic, Inc.
  • Hudson Dermatology, LLC
  • Indiana Clinical Trials Center
  • DermAssociates, PC
  • Great Lakes Research Group, Inc.
  • The Dermatology Group, P.C.
  • University of Pittsburgh Medical Center
  • Pflugerville Dermatology Clinical Research Center, Inc.
  • Kirk Barber Research
  • Enverus Medical
  • Skin Care Centre
  • Winnipeg Clinic Dermatology Research
  • UltraNova Skincare
  • Dermatrials Research Incorporated
  • The Guenther Dermatology Research Centre
  • SKiN Centre for Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

LEO 43204

LEO 43204 Dose 0.1%

LEO 43204 Dose 0.075%

Placebo

Arm Description

Open-label, dose-escalation, 2-day treatment

LEO 43204 dose 0.1% once daily for two consecutive days

LEO 43204 dose 0.075% once daily for two days

Placebo once daily for two days

Outcomes

Primary Outcome Measures

Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
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.
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count
Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2014
Last Updated
December 28, 2018
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02120456
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 43204
Arm Type
Experimental
Arm Description
Open-label, dose-escalation, 2-day treatment
Arm Title
LEO 43204 Dose 0.1%
Arm Type
Experimental
Arm Description
LEO 43204 dose 0.1% once daily for two consecutive days
Arm Title
LEO 43204 Dose 0.075%
Arm Type
Experimental
Arm Description
LEO 43204 dose 0.075% once daily for two days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily for two days
Intervention Type
Drug
Intervention Name(s)
LEO 43204
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
Description
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.
Time Frame
From Day 1 up to and including Day 8
Title
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count
Description
Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.
Time Frame
From baseline to Week 8
Secondary Outcome Measure Information:
Title
Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])
Description
Complete clearance was defined as a 100% reduction from baseline in AK count.
Time Frame
From baseline to Week 8
Title
Part 2: Participants With Partial Clearance of AKs (LOCF)
Description
Partial clearance was defined as at least 75% reduction from baseline in AK count.
Time Frame
From baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Goldenberg, MD
Organizational Affiliation
Mount Sinai School of Medicine, Dermatology Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Omni Dermatology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Torrance Clinical Research Institute Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Dermatology Associates and Research
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Leavitt Medical Associates of Florida
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Deaconess Clinic, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Hudson Dermatology, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
DermAssociates, PC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
The Dermatology Group, P.C.
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pflugerville Dermatology Clinical Research Center, Inc.
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Enverus Medical
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Skin Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Winnipeg Clinic Dermatology Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
UltraNova Skincare
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
Dermatrials Research Incorporated
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
Facility Name
The Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 1Z2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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