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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1173-5677 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Athenex, Inc. | INDUSTRY |
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In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp.
This study was an open-label, multicenter, activity, safety, tolerability, and PK study of KX2-391 Ointment administered topically to the face or scalp of participants with AK.
The study consists of Screening, Treatment, and Follow-up Periods. Eligible participants were received 3 or 5 consecutive days of topical treatment, applied at the study site. Blood samples for PK analysis were collected. Activity (lesion counts) and safety evaluations were performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KX2-391 50 mg (Days 1 to 5) | Experimental | Participants were applied 50 milligrams (mg) of KX2-391 Ointment 1% topically on face or scalp in 25 centimeter square (cm^2) treatment area, once daily for 5 consecutive days. |
|
| KX2-391 50 mg (Days 1 to 3) | Experimental | Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50 mg of KX2-391 Ointment 1% | Drug | Dose: 50 mg; Route of administration: Topical |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response of Actinic Keratosis | Complete response rate was defined as the percentage of participants achieving 100% clearance in the treatment area on the face or scalp at Day 57. | Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Partial Response of Actinic Keratosis | Partial response rate was defined as the percentage of participants achieving more than or equal to 75% clearance in the treatment area on the face or scalp at Day 57. | Day 57 |
| Overall Change From Baseline in Actinic Keratosis Lesion Counts at Day 8, 15, 29 and 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Fang, MD | Kinex Pharmaceuticals Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology Clinical Research | Fremont | California | 94538 | United States | ||
| eStudy Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33196758 | Derived | Kempers S, DuBois J, Forman S, Poon A, Cutler E, Wang H, Cutler D, Fang J, Kwan R. Tirbanibulin Ointment 1% as a Novel Treatment for Actinic Keratosis: Phase 1 and 2 Results. J Drugs Dermatol. 2020 Nov 1;19(11):1093-1100. doi: 10.36849/JDD.2020.5576. |
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A total of 168 participants (84 each cohort) were enrolled and treated in this study. This study consisted of 2 periods, first was Treatment and Follow-up period (up to Day 57) and second was Recurrence follow-up period (12 months post-Day 57).
This study was conducted at 16 sites in United States from 11 April 2016 to 22 December 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | KX2-391 50 mg (Days 1 to 5) | Participants were applied 50 milligrams (mg) of KX2-391 Ointment 1% topically on face or scalp in 25 centimeter square (cm^2) treatment area, once daily for 5 consecutive days. |
| FG001 | KX2-391 50 mg (Days 1 to 3) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment and Follow-up Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2016 | Feb 2, 2021 |
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| 50 mg of KX2-391 Ointment 1% | Drug | Dose: 50 mg; Route of administration: Topical |
|
Overall changes from baseline in actinic keratosis lesion counts has been reported. |
| Baseline, Days 8, 15, 29 and 57 |
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational Product (IP). An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs. | Baseline up to Day 57 (Treatment and follow-up period) |
| Number of Participants With Any Treatment-emergent Adverse Events During Recurrence Follow-up Period | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an IP. An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs. | From Day 57 up to 12-months post-Day 57 (Recurrence follow-up period) |
| Number of Participants With Maximal Post Baseline Local Skin Reactions (LSRs) | Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. Local skin reactions assessment included signs of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration on the treatment area. These signs were assessed using a 5-point grading scale ranging from 0 (not present) to 4 (worst), where (grade 0 = absent, grade 1 = slight, grade 2 = moderate, grade 3 = severe, grade 4 = very severe). | Day 57 |
| Number of Participants With Clinically Significant Abnormalities in Laboratory | Laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance was determined by the investigator. | Baseline to Day 57 |
| Number of Participants With Clinically Significant Abnormalities in 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. | Baseline up to Day 57 |
| Number of Participants With Clinically Significant Abnormalities in 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. | Baseline up to Day 57 |
| Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE) | A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator. | Baseline up to Day 57 |
| Maximum Observed Plasma Concentration (Cmax) of KX2-391 of KX2-391 | Cmax was defined as the maximum observed plasma concentration obtained directly from the concentration versus time curve. | Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1) |
| Area Under the Plasma Concentration Time Curve From Time 0 to the Last Sampling Time (AUCt) of KX2-391 | Area under the plasma concentration versus time curve from time zero to the last sampling time (t) at which the concentration is at or above the LLOQ. AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule. | Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1) |
| Minimum Observed Plasma Concentration (Cmin) of KX2-391 | Cmin was defined as minimum observed plasma concentration obtained directly from the concentration versus time curve. | Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1) |
| Accumulation Ratio (R) | Ratio calculated from AUC and Cmax found on the last day of treatment and Day 1. | Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1) |
| La Mesa |
| California |
| 91942 |
| United States |
| Palmtree Clinical Research, Inc. | Palm Springs | California | 92262 | United States |
| Horizons Clinical Research Center | Denver | Colorado | 80220 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| International Dermatology Research | Miami | Florida | 33144 | United States |
| Compass Research | Orlando | Florida | 32806 | United States |
| Forward Clinical Trials, Inc. | Tampa | Florida | 33624 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Dermatology and Laser Center of Charleston | Charleston | South Carolina | 29414 | United States |
| Institute of Clinical Research - Tennessee, LLC | Murfreesboro | Tennessee | 37130 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
| The Center for Skin Research | Houston | Texas | 77056 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Dermatology Clinical Research Center | San Antonio | Texas | 78229 | United States |
Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Recurrence Follow-up Period |
|
|
Safety analysis set included all participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | KX2-391 50 mg (Days 1 to 5) | Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 5 consecutive days. |
| BG001 | KX2-391 50 mg (Days 1 to 3) | Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Number of AK Lesions | Mean | Standard Deviation | Lesions |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Complete Response of Actinic Keratosis | Complete response rate was defined as the percentage of participants achieving 100% clearance in the treatment area on the face or scalp at Day 57. | Evaluable set included group of protocol-eligible participants who received 5 days (Cohort 1) or 3 days (Cohort 2) of study treatment and completed Day 1 and Day 57 AK lesion evaluations. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 57 |
|
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| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Partial Response of Actinic Keratosis | Partial response rate was defined as the percentage of participants achieving more than or equal to 75% clearance in the treatment area on the face or scalp at Day 57. | Per-protocol set included the group of protocol-eligible participants who received 5 days (Cohort 1) or 3 days (Cohort 2) of study treatment and completed at least one scheduled post treatment AK lesion evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 57 |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Change From Baseline in Actinic Keratosis Lesion Counts at Day 8, 15, 29 and 57 | Overall changes from baseline in actinic keratosis lesion counts has been reported. | Per-protocol set included the group of protocol-eligible participants who received 5 days (Cohort 1) or 3 days (Cohort 2) of study treatment and completed at least one scheduled post treatment AK lesion evaluation. | Posted | Median | Full Range | lesion count | Baseline, Days 8, 15, 29 and 57 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational Product (IP). An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs. | Safety analysis set included group of participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 57 (Treatment and follow-up period) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Treatment-emergent Adverse Events During Recurrence Follow-up Period | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an IP. An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs. | Recurrence follow-up set included the group of participants who achieved complete clearance at Day 57. | Posted | Count of Participants | Participants | From Day 57 up to 12-months post-Day 57 (Recurrence follow-up period) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Maximal Post Baseline Local Skin Reactions (LSRs) | Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. Local skin reactions assessment included signs of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration on the treatment area. These signs were assessed using a 5-point grading scale ranging from 0 (not present) to 4 (worst), where (grade 0 = absent, grade 1 = slight, grade 2 = moderate, grade 3 = severe, grade 4 = very severe). | Safety analysis set included group of participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Day 57 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory | Laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance was determined by the investigator. | Safety analysis set included group of participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline to Day 57 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormalities in 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. | Safety analysis set included group of participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 57 |
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormalities in 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. | Safety analysis set included group of participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 57 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE) | A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator. | Safety analysis set included group of participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 57 |
|
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of KX2-391 of KX2-391 | Cmax was defined as the maximum observed plasma concentration obtained directly from the concentration versus time curve. | Pharmacokinetic (PK) Analysis Set included the group of participants who received study treatment and completed at least one scheduled post-treatment PK evaluation. | Posted | Mean | Standard Deviation | nanograms/milliliter (ng/mL) | Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1) |
|
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| Secondary | Area Under the Plasma Concentration Time Curve From Time 0 to the Last Sampling Time (AUCt) of KX2-391 | Area under the plasma concentration versus time curve from time zero to the last sampling time (t) at which the concentration is at or above the LLOQ. AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule. | PK Analysis Set included the group of participants who received study treatment and completed at least one scheduled post-treatment PK evaluation. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter (ng*h/mL) | Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1) |
|
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| Secondary | Minimum Observed Plasma Concentration (Cmin) of KX2-391 | Cmin was defined as minimum observed plasma concentration obtained directly from the concentration versus time curve. | PK Analysis Set included the group of participants who received study treatment and completed at least one scheduled post-treatment PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1) |
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| Secondary | Accumulation Ratio (R) | Ratio calculated from AUC and Cmax found on the last day of treatment and Day 1. | PK Analysis Set included the group of participants who received study treatment and completed at least one scheduled post-treatment PK evaluation. | Posted | Mean | Standard Deviation | ratio | Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1) |
|
|
Baseline up to Recurrence Follow-up (12 months post-day 57)
Safety analysis set included group of participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KX2-391 50 mg (Days 1 to 5) | Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 5 consecutive days. | 0 | 84 | 4 | 84 | 37 | 84 |
| EG001 | KX2-391 50 mg (Days 1 to 3) | Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days. | 0 | 84 | 3 | 84 | 19 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis Coronary Artery | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| VIIth Nerve Paralysis | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular Block First Degree | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Defect Conduction Intraventricular | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eye Discharge | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eye Pruritus | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Application Site Pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Application Site Pruritus | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Feeling Of Body Temperature Change | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dermatitis Contact | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Skin Injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT Prolonged | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Meniscus Injury | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Muscle Strain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma Of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vertigo | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Actinic Keratosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hair Colour Changes | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Penile Ulceration | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Skin Injury | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tooth Extraction | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Global Clinical Development | Almirall S.A. | +34932913000 | rd@almirall.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2018 | Feb 2, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Non-compliance |
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| Withdrawal by Subject |
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| Other un-specified |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days. |
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Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days. |
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| Participants |
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