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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1191-8233 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Athenex, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp |
|
| KX2-391 Ointment 1% | Experimental | KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Vehicle Ointment was used in participants with Clinically typical AK on the face or scalp. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 57 |
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Inclusion Criteria
Exclusion Criteria
Clinically atypical and/or rapidly changing AK lesions on the treatment area
Location of the selected area is:
Been previously treated with KX2-391 Ointment
Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57
Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the treatment area or within 2 cm of the treatment area, within 8 weeks prior to the Screening visit
Use of the following therapies and/or medications within 2 weeks prior to the Screening visit:
Use of the following therapies and/or medications within 4 weeks prior to the Screening visit:
Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit
A history of sensitivity and/or allergy to any of the ingredients in the study medication
A skin disease (eg, atopic dermatitis, psoriasis, eczema) or condition (eg, scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participants to unacceptable risk by study participation
Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation
Females who are pregnant or nursing
Participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing
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| Name | Affiliation | Role |
|---|---|---|
| Jane Fang, MD | Athenex, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | United States | ||
| Advanced Research Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33567191 | Derived | Blauvelt A, Kempers S, Lain E, Schlesinger T, Tyring S, Forman S, Ablon G, Martin G, Wang H, Cutler DL, Fang J, Kwan MR; Phase 3 Tirbanibulin for Actinic Keratosis Group. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. N Engl J Med. 2021 Feb 11;384(6):512-520. doi: 10.1056/NEJMoa2024040. |
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A total of 351 participants were enrolled in the study, 176 participants were randomized to the Vehicle control (121 face, 55 scalp treatment) and 175 participants were randomized to KX2-391 Ointment 1 percent (%) (119 face, 56 scalp treatment).
This study was conducted at 31 sites in United States from 18 September 2017 to 24 April 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp |
| FG001 | KX2-391 Ointment 1% | KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment and Response Assessment 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 | Feb 18, 2018 | Feb 2, 2021 |
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This study tested KX2-391 Ointment 1% against a placebo.
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All Central Vendors and the sponsor were masked. The sponsor was unblind at the end of Day 57.
| KX2-391 Ointment 1% | Drug | The experimental drug, KX2-391 Ointment 1% was used in participants with Clinically typical AK on the face or scalp. |
|
| 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). |
| 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From Baseline (Day 1 predose) up to Day 57 |
| Glendale |
| Arizona |
| 85308 |
| United States |
| Center For Dermatology Clinical Research | Fremont | California | 94538 | United States |
| Contour Dermatology | Rancho Mirage | California | 92270 | United States |
| Western States Clincial Research, Inc. | Wheat Ridge | Colorado | 80033 | United States |
| Skin care Research, Inc | Boca Raton | Florida | 33486 | United States |
| Olympian Clinical Research | Clearwater | Florida | 33756 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| Leavitt Medical Associates of Florida d/b/a Ameriderm Research | Ormond Beach | Florida | 32174 | United States |
| Arlington Dermatology | Arlington Heights | Illinois | 60005 | United States |
| Deaconess Clinic Downtown | Evansville | Indiana | 47713 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| ActivMed Practices & Research, Inc. | Beverly | Massachusetts | 01915 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Skin Specialists PC | Omaha | Nebraska | 68144 | United States |
| JDR Dermatology Research | Las Vegas | Nevada | 89148 | United States |
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Mount Sinai Beth Israel | New York | New York | 10013 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| PMG Research of Cary | Cary | North Carolina | 27511 | United States |
| OnSite Clinical Solutions, LLC | Charlotte | North Carolina | 28277 | United States |
| PMG Research of Winston-Salem,LLC | Winston-Salem | North Carolina | 27103 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Synexus US | Greer | South Carolina | 29650 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78660 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84117 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Recurrence Follow-up Period |
|
|
Intent to treat (ITT) population included all participants randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp |
| BG001 | KX2-391 Ointment 1% | KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp |
| 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 (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. | ITT population included all participants randomized in the study. | Posted | Number | percentage of participants | Day 57 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included all participants randomized in the study. | Posted | Number | percentage of participants | Day 57 |
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| Secondary | 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). | ITT population included all participants randomized in the study. | Posted | Median | Full Range | lesion count | Days 8, 15, 29 and 57 |
|
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| Secondary | 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. | Recurrence Follow-up Population includes participants achieved complete clearance at the Day 57visit. The recurrence rate was evaluated only for KX2-391 Ointment 1% arm, pre-specified in protocol. | Posted | Number | percentage of participants | 3, 6, 9 and 12 months post-Day 57 |
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| Secondary | 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). | Safety analysis population consisted of all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Day 57 |
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| Secondary | 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. | Safety analysis population consisted of all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57 |
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| Secondary | 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. | Safety analysis population included all randomized participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | Baseline (Day 1 predose) up to Day 57 |
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| Secondary | 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. | Recurrence Follow-up Population includes participants achieved complete clearance at the Day 57 visit. | Posted | Count of Participants | Participants | From Day 57 up to 12-months post-Day 57 |
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| Secondary | 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. | Safety Population included all randomized participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | From Baseline (Day 1 predose) up to Day 57 |
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| Secondary | 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. | Safety analysis population consisted of all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From Baseline (Day 1 predose) up to Day 57 |
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| Secondary | 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. | Safety analysis population included all randomized participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | From Baseline (Day 1 predose) up to Day 57 |
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| Secondary | 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. | Safety analysis population consisted of all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From Baseline (Day 1 predose) up to Day 57 |
|
|
From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety analysis population included all randomized participants who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | The Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp | 1 | 176 | 2 | 176 | 62 | 176 |
| EG001 | KX2-391 Ointment 1% | KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp | 0 | 175 | 1 | 175 | 68 | 175 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic valve stenosis | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Hairy cell leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Nodal rhythm | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Benign familial pemphigus | Congenital, familial and genetic disorders | 20.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | 20.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 20.0 | Non-systematic Assessment |
| |
| Blepharospasm | Eye disorders | 20.0 | Non-systematic Assessment |
| |
| Iritis | Eye disorders | 20.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Sensitivity of teeth | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Application site discomfort | General disorders | 20.0 | Non-systematic Assessment |
| |
| Application site dryness | General disorders | 20.0 | Non-systematic Assessment |
| |
| Application site pain | General disorders | 20.0 | Non-systematic Assessment |
| |
| Application site paraesthesia | General disorders | 20.0 | Non-systematic Assessment |
| |
| Application site pruritus | General disorders | 20.0 | Non-systematic Assessment |
| |
| Application site warmth | General disorders | 20.0 | Non-systematic Assessment |
| |
| Cyst | General disorders | 20.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | 20.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | 20.0 | Non-systematic Assessment |
| |
| Pain | General disorders | 20.0 | Non-systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | 20.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | 20.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Spinal column injury | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Cardiac murmur | Investigations | 20.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | 20.0 | Non-systematic Assessment |
| |
| Glucose urine present | Investigations | 20.0 | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Heart rate irregular | Investigations | 20.0 | Non-systematic Assessment |
| |
| Protein urine | Investigations | 20.0 | Non-systematic Assessment |
| |
| Protein urine present | Investigations | 20.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Chest wall mass | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of head and neck | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Essential tremor | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | 20.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 20.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | 20.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Skin odour abnormal | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | 20.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 20.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | 20.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | 20.0 | Non-systematic Assessment |
|
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 | Jun 4, 2019 | Feb 2, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| AK recurrence during the Recurrence Follow-Up Period |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp
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