This Phase III study is designed to evaluate the efficacy and safety of KX2-391 Ointment in adult participants when applied to an area of skin containing 4-8 stable, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.
This study was a double-blinded, multicenter, activity, and safety study of KX2-391 Ointment administered topically to the face or scalp of participants with actinic keratosis. The study consists of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received 5 consecutive days of topical treatment, to be applied at the study site. Activity (lesion counts) and safety evaluations was performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
351
Vehicle Ointment was used in participants with Clinically typical AK on the face or scalp.
The experimental drug, KX2-391 Ointment 1% was used in participants with Clinically typical AK on the face or scalp.
Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions
Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.
Time frame: Day 57
Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57
Partial clearance rate of AK lesions was defined as the percentage of participants with a greater than or equal to (\>=) 75% reduction in the number of AK lesions identified at Baseline (Day 1 predose) in the treatment area.
Time frame: Day 57
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57
Overall the change from baseline in lesion count at each visit were summarized and reported using descriptive statistics by treatment location (face or scalp).
Time frame: Days 8, 15, 29 and 57
Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57
Recurrence rate was estimated based on Kaplan-Meier method, with recurrence define as appearance of any AK lesions in the treatment area, including those recurred or newly identified.
Time frame: 3, 6, 9 and 12 months post-Day 57
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. The LSR assessment was an Investigator's (or sub-investigator's) assessment of the following signs on the treatment area: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. The LSRs were graded on a 4-point scale ranging from 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense).
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Advanced Research Associates
Glendale, Arizona, United States
Center For Dermatology Clinical Research
Fremont, California, United States
Contour Dermatology
Rancho Mirage, California, United States
Western States Clincial Research, Inc.
Wheat Ridge, Colorado, United States
Skin care Research, Inc
Boca Raton, Florida, United States
Olympian Clinical Research
Clearwater, Florida, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach, Florida, United States
Arlington Dermatology
Arlington Heights, Illinois, United States
...and 20 more locations
Time frame: Day 57
Number of Participants With Pigmentation and Scarring in the Treatment Area
Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed.
Time frame: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57
Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests
An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. TEAEs (serious and non-serious) were defined as either those AEs with onset after first dose or those pre-existing AEs that worsen after first dose. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy.
Time frame: Baseline (Day 1 predose) up to Day 57
Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy.
Time frame: From Day 57 up to 12-months post-Day 57
Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis
Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator.
Time frame: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Vital Signs
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Time frame: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Physical Examination
A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.
Time frame: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs)
ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator.
Time frame: From Baseline (Day 1 predose) up to Day 57