Safety and Efficacy of Escalating Doses of LEO 43204 Appl... | NCT02120456 | Trialant
NCT02120456
Sponsor
LEO Pharma
Status
Completed
Last Update Posted
Mar 6, 2025Actual
Enrollment
224Actual
Phase
Phase 1Phase 2
Conditions
Actinic Keratosis
Interventions
LEO 43204
Placebo
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT02120456
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
LP0084-1015
Secondary IDs
Not provided
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
Acronym
Not provided
Organization
LEO PharmaINDUSTRY
Status Module
Record Verification Date
Nov 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2014
Primary Completion Date
May 2015Actual
Completion Date
May 2015Actual
First Submitted Date
Apr 18, 2014
First Submission Date that Met QC Criteria
Apr 21, 2014
First Posted Date
Apr 22, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 14, 2018
Results First Submitted that Met QC Criteria
Dec 28, 2018
Results First Posted Date
Jan 4, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 18, 2016
Certification/Extension First Submitted that Passed QC Review
Apr 18, 2016
Certification/Extension First Posted Date
May 17, 2016Estimated
Last Update Submitted Date
Feb 21, 2025
Last Update Posted Date
Mar 6, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
LEO PharmaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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
Detailed Description
Not provided
Conditions Module
Conditions
Actinic Keratosis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
224Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LEO 43204
Experimental
Open-label, dose-escalation, 2-day treatment
Drug: LEO 43204
LEO 43204 Dose 0.1%
Experimental
LEO 43204 dose 0.1% once daily for two consecutive days
Drug: LEO 43204
LEO 43204 Dose 0.075%
Experimental
LEO 43204 dose 0.075% once daily for two days
Drug: LEO 43204
Placebo
Placebo Comparator
Placebo once daily for two days
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LEO 43204
Drug
LEO 43204
LEO 43204 Dose 0.075%
LEO 43204 Dose 0.1%
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
From Day 1 up to and including Day 8
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.
From baseline to Week 8
Secondary Outcomes
Measure
Description
Time Frame
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.
From baseline to Week 8
Part 2: Participants With Partial Clearance of AKs (LOCF)
Other Outcomes
Not provided
Eligibility Module
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)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Gary Goldenberg, MD
Mount Sinai School of Medicine, Dermatology Faculty
Partial clearance was defined as at least 75% reduction from baseline in AK count.
From baseline to Week 8
Lomita
California
90717
United States
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego
California
92121
United States
Dermatology Associates and Research
Coral Gables
Florida
33134
United States
Leavitt Medical Associates of Florida
Ormond Beach
Florida
32174
United States
Deaconess Clinic, Inc.
Evansville
Indiana
47713
United States
Hudson Dermatology, LLC
Evansville
Indiana
47714
United States
Indiana Clinical Trials Center
Plainfield
Indiana
46168
United States
DermAssociates, PC
Rockville
Maryland
20850
United States
Great Lakes Research Group, Inc.
Bay City
Michigan
48706
United States
The Dermatology Group, P.C.
Verona
New Jersey
07044
United States
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
15213
United States
Pflugerville Dermatology Clinical Research Center, Inc.
Pflugerville
Texas
78660
United States
Kirk Barber Research
Calgary
Alberta
T2G 1B1
Canada
Enverus Medical
Surrey
British Columbia
V3R 6A7
Canada
Skin Care Centre
Vancouver
British Columbia
V5Z 4E8
Canada
Winnipeg Clinic Dermatology Research
Winnipeg
Manitoba
R3C 0N2
Canada
UltraNova Skincare
Barrie
Ontario
L4M 6L2
Canada
Dermatrials Research Incorporated
Hamilton
Ontario
L8N 1V6
Canada
The Guenther Dermatology Research Centre
London
Ontario
N6A 3H7
Canada
SKiN Centre for Dermatology
Peterborough
Ontario
K9J 1Z2
Canada
Once daily treatment for two consecutive days with LEO 43204 gel 0.025% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.
FG002
Part 1: LEO 43204 Gel 0.037%
Once daily treatment for two consecutive days with LEO 43204 gel 0.037% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.
FG003
Part 1: LEO 43204 Gel 0.05%
Once daily treatment for two consecutive days with LEO 43204 gel 0.05% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.
FG004
Part 1: LEO 43204 Gel 0.075%
Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.
FG005
Part 1: LEO 43204 Gel 0.1%
Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.
FG006
Part 2: LEO 43204 Vehicle Gel
Once daily treatment for two consecutive days with LEO 43204 vehicle gel on sun exposed area of 250 cm2 on the extremities or trunk (except chest).
FG007
Part 2: LEO 43204 Gel 0.075%
Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).
FG008
Part 2: LEO 43204 Gel 0.1%
Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).
FG00012 subjects
FG00112 subjects
FG00212 subjects
FG00312 subjects
FG00412 subjects
FG0059 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG00012 subjects
FG00112 subjects
FG00212 subjects
FG00312 subjects
FG00412 subjects
FG0059 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Part 2 Double-blind Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00632 subjects
FG00760 subjects
FG00863 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: LEO 43204 Gel 0.018%
Once daily treatment for two consecutive days with LEO 43204 gel 0.018%
BG001
Part 1: LEO 43204 Gel 0.025%
Once daily treatment for two consecutive days with LEO 43204 gel 0.025%
BG002
Part 1: LEO 43204 Gel 0.037%
Once daily treatment for two consecutive days with LEO 43204 gel 0.037%
BG003
Part 1: LEO 43204 Gel 0.05%
Once daily treatment for two consecutive days with LEO 43204 gel 0.05%
BG004
Part 1: LEO 43204 Gel 0.075%
Once daily treatment for two consecutive days with LEO 43204 gel 0.075%
BG005
Part 1: LEO 43204 Gel 0.1%
Once daily treatment for two consecutive days with LEO 43204 gel 0.1%
BG006
Part 2: LEO 43204 Vehicle Gel
Once daily treatment for two consecutive days LEO 43204 vehicle gel
BG007
Part 2: LEO 43204 Gel 0.075%
Once daily treatment for two consecutive days LEO 43204 gel 0.075%
BG008
Part 2: LEO 43204 Gel 0.1%
Once daily treatment for two consecutive days LEO 43204 gel 0.1%
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00112
BG00212
BG00312
BG00412
BG0059
BG00632
BG00760
BG00863
BG009224
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0013
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Canada
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Posted
Count of Participants
Participants
From Day 1 up to and including Day 8
ID
Title
Description
OG000
Part 1: LEO 43204 Gel 0.018%
Once daily treatment for two consecutive days with LEO 43204 gel 0.018%
OG001
Part 1: LEO 43204 Gel 0.025%
Once daily treatment for two consecutive days with LEO 43204 gel 0.025%
OG002
Part 1: LEO 43204 Gel 0.037%
Once daily treatment for two consecutive days with LEO 43204 gel 0.037%
OG003
Part 1: LEO 43204 Gel 0.05%
Once daily treatment for two consecutive days with LEO 43204 gel 0.05%
OG004
Part 1: LEO 43204 Gel 0.075%
Once daily treatment for two consecutive days with LEO 43204 gel 0.075%
OG005
Part 1: LEO 43204 Gel 0.1%
Once daily treatment for two consecutive days with LEO 43204 gel 0.1%
Units
Counts
Participants
OG00012
OG00112
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
Yes
OG0000
OG0010
OG0022
OG003
Primary
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.
Posted
Mean
95% Confidence Interval
percentage of reduction
From baseline to Week 8
ID
Title
Description
OG000
Part 2: LEO 43204 Vehicle Gel
Once daily treatment for two consecutive days LEO 43204 vehicle gel
OG001
Part 2: LEO 43204 Gel 0.075%
Once daily treatment for two consecutive days LEO 43204 gel 0.075%
OG002
Part 2: LEO 43204 Gel 0.1%
Once daily treatment for two consecutive days LEO 43204 gel 0.1%
Units
Counts
Participants
OG000
Secondary
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.
Posted
Count of Participants
Participants
From baseline to Week 8
ID
Title
Description
OG000
Part 2: LEO 43204 Vehicle Gel
Once daily treatment for two consecutive days LEO 43204 vehicle gel
OG001
Part 2: LEO 43204 Gel 0.075%
Once daily treatment for two consecutive days LEO 43204 gel 0.075%
OG002
Part 2: LEO 43204 Gel 0.1%
Once daily treatment for two consecutive days LEO 43204 gel 0.1%
Units
Counts
Participants
OG000
Secondary
Part 2: Participants With Partial Clearance of AKs (LOCF)
Partial clearance was defined as at least 75% reduction from baseline in AK count.
Posted
Count of Participants
Participants
From baseline to Week 8
ID
Title
Description
OG000
Part 2: LEO 43204 Vehicle Gel
Once daily treatment for two consecutive days LEO 43204 vehicle gel
OG001
Part 2: LEO 43204 Gel 0.075%
Once daily treatment for two consecutive days LEO 43204 gel 0.075%
OG002
Part 2: LEO 43204 Gel 0.1%
Once daily treatment for two consecutive days LEO 43204 gel 0.1%
Units
Counts
Participants
OG000
Time Frame
Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: LEO 43204 Gel 0.018%
Once daily treatment for two consecutive days with LEO 43204 gel 0.018%
0
12
3
12
EG001
Part 1: LEO 43204 Gel 0.025%
Once daily treatment for two consecutive days with LEO 43204 gel 0.025%
0
12
3
12
EG002
Part 1: LEO 43204 Gel 0.037%
Once daily treatment for two consecutive days with LEO 43204 gel 0.037%
0
12
5
12
EG003
Part 1: LEO 43204 Gel 0.05%
Once daily treatment for two consecutive days with LEO 43204 gel 0.05%
0
12
9
12
EG004
Part 1: LEO 43204 Gel 0.075%
Once daily treatment for two consecutive days with LEO 43204 gel 0.075%
0
12
10
12
EG005
Part 1: LEO 43204 Gel 0.1%
Once daily treatment for two consecutive days with LEO 43204 gel 0.1%
0
9
7
9
EG006
Part 2: LEO 43204 Vehicle Gel
Once daily treatment for two consecutive days LEO 43204 vehicle gel
0
32
6
32
EG007
Part 2: LEO 43204 Gel 0.075%
Once daily treatment for two consecutive days LEO 43204 gel 0.075%
1
60
36
60
EG008
Part 2: LEO 43204 Gel 0.1%
Once daily treatment for two consecutive days LEO 43204 gel 0.1%
2
63
39
63
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG004
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Application site pruritus
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected12 at risk
EG0011 affected12 at risk
EG0024 affected12 at risk
EG0037 affected12 at risk
EG0047 affected12 at risk
EG0056 affected9 at risk
EG0061 affected32 at risk
EG00723 affected60 at risk
EG00826 affected63 at risk
Application site pain
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected12 at risk
EG0011 affected12 at risk
EG0022 affected12 at risk
EG003
Application site paraesthesia
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Application site vesicles
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Fatigue
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Foreign body reaction
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Administration site reaction
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Application site discomfort
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Application site inflammation
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Oedema peripheral
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Helicobacter gastritis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Viral infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Tension headache
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Tremor
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dry eye
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Eye irritation
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Platelet count increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Haematoma
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Depression
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Trial Disclosure Specialist
LEO Pharma A/S
disclosure@leo-pharma.com
ID
Term
D055623
Keratosis, Actinic
Ancestor Terms
ID
Term
D011230
Precancerous Conditions
D009369
Neoplasms
D007642
Keratosis
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000612882
LEO 43204
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG00630 subjects
FG00760 subjects
FG00862 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
Withdrawal of consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
Unable to attend visit due to work
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Between 18 and 65 years
BG0009
BG0012
BG0023
BG0034
BG0045
BG0053
BG00611
BG00722
BG00823
BG00982
>=65 years
BG0003
BG00110
BG0029
BG0038
BG0047
BG0056
BG00621
BG00738
BG00840
BG009142
6
BG0036
BG0046
BG0056
BG00615
BG00724
BG00826
BG00996
Male
BG0008
BG0019
BG0026
BG0036
BG0046
BG0053
BG00617
BG00736
BG00837
BG009128
0
BG0030
BG0040
BG0050
BG00611
BG00720
BG00821
BG00952
United States
Title
Measurements
BG00012
BG00112
BG00212
BG00312
BG00412
BG0059
BG00621
BG00740
BG00842
BG009172
12
OG00412
OG0059
1
OG0041
OG0050
No
OG00012
OG00112
OG00210
OG00311
OG00411
OG0059
32
OG00160
OG00263
Title
Denominators
Categories
Title
Measurements
OG00032.7(17.9 to 44.8)
OG00170.0(64.1 to 74.9)
OG00262.2(55.5 to 67.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.
Negative binominal regression
<0.001
Rate ratio
0.45
2-Sided
95
0.34
0.58
Superiority
OG000
OG002
Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.
Negative binominal regression
<0.001
Rate ratio
0.56
2-Sided
95
0.44
0.73
Superiority
OG001
OG002
Negative binominal regression
0.058
Rate ratio
1.26
2-Sided
95
0.99
1.60
Superiority
32
OG00160
OG00263
Title
Denominators
Categories
Title
Measurements
OG0003
OG0016
OG0026
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log binomial regression with factors treatment group and baseline AK count as a covariate.
Log binomial regression
0.94
Ratio of clearance rates
1.05
2-Sided
95
0.30
4.73
Superiority
OG000
OG002
Log binomial regression with factors treatment group and baseline AK count as a covariate.
Log binomial regression
1.00
Ratio of clearance rates
1.00
2-Sided
95
0.28
4.51
Superiority
OG001
OG002
Log binomial regression with factors treatment group and baseline AK count as a covariate.
Log binomial regression
0.93
Ratio of clearance rates
0.95
2-Sided
95
0.31
2.89
Superiority
32
OG00160
OG00263
Title
Denominators
Categories
Title
Measurements
OG0005
OG00127
OG00228
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log binomial regression with factors treatment group and baseline AK count as a covariate.
Log binomial regression
0.003
Ratio of clearance rates
2.88
2-Sided
95
1.36
7.85
Superiority
OG000
OG002
Log binomial regression with factors treatment group and baseline AK count as a covariate.
Log binomial regression
0.004
Ratio of clearance rates
2.84
2-Sided
95
1.35
7.74
Superiority
OG001
OG002
Log binomial regression with factors treatment group and baseline AK count as a covariate.