Back to resultsEfficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
LEO 43204 gel
Vehicle gel
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis
Eligibility Criteria
Inclusion Criteria:
- Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
- Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area
Exclusion Criteria:
- Location of the treatment area (full balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
- Treatment with ingenol mebutate gel in the treatment area within the last 12 months
- Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
- History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)
Sites / Locations
- Long Island Skin Cancer & Dermatologic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LEO 43204
Vehicle gel
Arm Description
Treatment once daily for 3 days
Treatment once daily for 3 days
Outcomes
Primary Outcome Measures
Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Week 4 and Week 8.
Complete clearance was defined as no clinically visible AKs in the treatment area.
Secondary Outcome Measures
Percentage of Participants With Partial Clearance of AKs
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.
Percentage of Participants With Partial Clearance of AKs
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.
Percent Reduction in AK Count in the Treatment Area Compared to Baseline
The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable. The table presents adjusted mean percent reduction at Week 8 from baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02547363
Brief Title
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
Official Title
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 17, 2016 (Actual)
Study Completion Date
August 2017 (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
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment.
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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
373 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 43204
Arm Type
Experimental
Arm Description
Treatment once daily for 3 days
Arm Title
Vehicle gel
Arm Type
Placebo Comparator
Arm Description
Treatment once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
LEO 43204 gel
Other Intervention Name(s)
Ingenol Disoxate
Intervention Type
Drug
Intervention Name(s)
Vehicle gel
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
Description
The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Week 4 and Week 8.
Complete clearance was defined as no clinically visible AKs in the treatment area.
Time Frame
At Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants With Partial Clearance of AKs
Description
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.
Time Frame
At Week 8
Title
Percentage of Participants With Partial Clearance of AKs
Description
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.
Time Frame
At Week 4
Title
Percent Reduction in AK Count in the Treatment Area Compared to Baseline
Description
The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable. The table presents adjusted mean percent reduction at Week 8 from baseline.
Time Frame
At Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area
Exclusion Criteria:
Location of the treatment area (full balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
Treatment with ingenol mebutate gel in the treatment area within the last 12 months
Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel M Siegel, MD
Organizational Affiliation
Long Island Skin Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island Skin Cancer & Dermatologic Surgery
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
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