A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp
- Conditions
- Actinic Keratoses
- Interventions
- Drug: KX2-391 Ointment 1%Drug: Placebo
- Registration Number
- NCT03285477
- Lead Sponsor
- Almirall, S.A.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 351
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KX2-391 Ointment 1% KX2-391 Ointment 1% KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp Placebo Placebo Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp
- Primary Outcome Measures
Name Time Method Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions Day 57 Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57 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.
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57 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).
Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57 3, 6, 9 and 12 months post-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.
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR) Day 57 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).
Number of Participants With Pigmentation and Scarring in the Treatment Area Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57 Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed.
Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests Baseline (Day 1 predose) up to Day 57 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.
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 From Day 57 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.
Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis From Baseline (Day 1 predose) up to Day 57 Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator.
Number of Participants With Clinically Significant Safety Observations- Vital Signs From Baseline (Day 1 predose) up to Day 57 Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs) From Baseline (Day 1 predose) up to Day 57 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.
Number of Participants With Clinically Significant Safety Observations- Physical Examination From Baseline (Day 1 predose) up to Day 57 A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.
Trial Locations
- Locations (30)
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Olympian Clinical Research
🇺🇸Clearwater, Florida, United States
Arlington Dermatology
🇺🇸Arlington Heights, Illinois, United States
PMG Research of Cary
🇺🇸Cary, North Carolina, United States
JDR Dermatology Research
🇺🇸Las Vegas, Nevada, United States
Contour Dermatology
🇺🇸Rancho Mirage, California, United States
Center For Dermatology Clinical Research
🇺🇸Fremont, California, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Western States Clincial Research, Inc.
🇺🇸Wheat Ridge, Colorado, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Skin care Research, Inc
🇺🇸Boca Raton, Florida, United States
Psoriasis Treatment Center of Central New Jersey
🇺🇸East Windsor, New Jersey, United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
🇺🇸Ormond Beach, Florida, United States
ActivMed Practices & Research, Inc.
🇺🇸Beverly, Massachusetts, United States
Synexus US
🇺🇸Greer, South Carolina, United States
Advanced Research Associates
🇺🇸Glendale, Arizona, United States
Austin Institute for Clinical Research, Inc.
🇺🇸Pflugerville, Texas, United States
Skin Specialists PC
🇺🇸Omaha, Nebraska, United States
Dermatology Research Center, Inc.
🇺🇸Salt Lake City, Utah, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Deaconess Clinic Downtown
🇺🇸Evansville, Indiana, United States
Mount Sinai Beth Israel
🇺🇸New York, New York, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
OnSite Clinical Solutions, LLC
🇺🇸Charlotte, North Carolina, United States
J&S Studies, Inc.
🇺🇸College Station, Texas, United States
PMG Research of Winston-Salem,LLC
🇺🇸Winston-Salem, North Carolina, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States