Back to resultsSafety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LEO 43204
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, 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).
Sites / Locations
- Long Island Skin Cancer and Dermatologic Surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
LEO 43204, 0.018% once daily for 3 days
LEO 43204, 0.037% once daily for 3 days
LEO 43204, 0.1% once daily for 3 days
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)
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
Secondary Outcome Measures
Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
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.
Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8.
Percentage of Participants With Complete Clearance of AKs
Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02305888
Brief Title
Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 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
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.
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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 43204, 0.018% once daily for 3 days
Arm Type
Experimental
Arm Title
LEO 43204, 0.037% once daily for 3 days
Arm Type
Experimental
Arm Title
LEO 43204, 0.1% once daily for 3 days
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LEO 43204
Intervention Description
Treatment of actinic keratosis
Primary Outcome Measure Information:
Title
Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)
Description
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
Time Frame
8 days / From baseline (Day 1) to Day 8
Secondary Outcome Measure Information:
Title
Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Description
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.
Time Frame
4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Title
Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Description
Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8.
Time Frame
4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Title
Percentage of Participants With Complete Clearance of AKs
Description
Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
Time Frame
8 weeks
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, 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel M Siegel, MD
Organizational Affiliation
Long Island Skin Cancer and Dermatologic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island Skin Cancer and Dermatologic Surgery
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29399263
Citation
Siegel DM, Tyring S, Nahm WK, Osterdal ML, Petersen AH, Berman B. Three-day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: A Phase II Trial. J Clin Aesthet Dermatol. 2017 Dec;10(12):19-26. Epub 2017 Dec 1.
Results Reference
derived
PubMed Identifier
29399258
Citation
Berman B, Tyring S, Nahm WK, Osterdal ML, Petersen AH, Siegel DM. Three-Day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: Cosmetic Outcomes and Patient Satisfaction from a Phase II Trial. J Clin Aesthet Dermatol. 2017 Nov;10(11):26-32. Epub 2017 Nov 1.
Results Reference
derived
Learn more about this trial
Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively
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