Back to resultsSafety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LEO 43204
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis
Eligibility Criteria
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)
Sites / Locations
- Gwinnett Clinical Research Center, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Part 1: LEO 43204
Part 2: LEO 43204 x dose
Part 2: LEO 43204 Y dose
Part 2: Placebo
Arm Description
Open-label, dose escalation, 2 days treatment
X dose for 2 days treatment
Y dose for 2 days treatment
Placebo for 2 days treatment
Outcomes
Primary Outcome Measures
Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
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.
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Lesion Count
Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) in the selected treatment area.
Secondary Outcome Measures
Part 2: Participants With Complete Clearance of AKs
Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in AK count.
Part 2: Participants With Partial Clearance of AKs
Partial clearance of AKs at Week 8 was defined as at least 75% reduction from baseline in AK count.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02100813
Brief Title
Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 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
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
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
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: LEO 43204
Arm Type
Other
Arm Description
Open-label, dose escalation, 2 days treatment
Arm Title
Part 2: LEO 43204 x dose
Arm Type
Active Comparator
Arm Description
X dose for 2 days treatment
Arm Title
Part 2: LEO 43204 Y dose
Arm Type
Active Comparator
Arm Description
Y dose for 2 days treatment
Arm Title
Part 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 2 days treatment
Intervention Type
Drug
Intervention Name(s)
LEO 43204
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
Description
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.
Time Frame
From Day 1 up to and including Day 8
Title
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Lesion Count
Description
Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) in the selected treatment area.
Time Frame
From baseline to Week 8
Secondary Outcome Measure Information:
Title
Part 2: Participants With Complete Clearance of AKs
Description
Complete clearance of AKs at Week 8 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
Description
Partial clearance of AKs at Week 8 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Weiss, MD
Organizational Affiliation
Gwinnett Clinical Research Center, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gwinnett Clinical Research Center, Inc.
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis
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