Part 1: To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
Omni Dermatology
Part 1: Number of Participants Experiencing a Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
The number of participants experiencing DLTs are tabulated by treatment group. This 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(cohorts 1 to 4) or less than 6 out of 18 participants(cohorts 5 and 6) experiencing a DLT DLT was defined as one or more of the following 3 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 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 4 being the highest grade of severity.
Time frame: From Day 1 up to and including Day 8
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Counts (Multiple Imputation)
Time frame: At Week 8
Part 2: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) (Multiple Imputation)
Complete clearance was defined as a 100% reduction from baseline in AK count. For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with complete clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with complete clearance in observed cases.
Time frame: At Week 8
Part 2: Percentage of Participants With Partial Clearance of AKs (Multiple Imputation)
Partial clearance was defined as at least 75% reduction from baseline in AK count. For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with partial clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with partial clearance in observed cases.
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Phoenix, Arizona, United States
Torrance Clinical Research Institute Inc.
Lomita, California, United States
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, United States
Leavitt Medical Associates of Florida
Ormond Beach, Florida, United States
Clinical Research Center, Morsani Center for Advanced Healthcare
Tampa, Florida, United States
Research Institute of Deaconess Clinic
Evansville, Indiana, United States
Hudson Dermatology, LLC
Evansville, Indiana, United States
DermAssociates, PC
Rockville, Maryland, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Henry Ford Medical Center, Dept. of Dermatology
West Bloomfield, Michigan, United States
...and 15 more locations
Time frame: At Week 8