Actinic Keratosis
Conditions
Keywords
Keratosis, Tirbanibulin
Brief summary
The purpose of the study is to assess treatment satisfaction on Day 57 in participants with Actinic Keratoses (AK) of the face or scalp following treatment with tirbanibulin ointment 1 percent (%) administered once daily for 5 consecutive days.
Interventions
DRUGTirbanibulin 2.5 mg ointment
Participants will apply tirbanibulin 2.5 mg ointment topically for 5 consecutive days over 25 square centimeters (cm\^2) of the face or scalp.
Sponsors
Almirall, S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent. 2. Males or females aged greater than or equal to (\>=)18 years. 3. Diagnosis of clinically typical AK in one contiguous area on the face or scalp with a treatment area of 25\^cm2 containing 4-8 AK lesions. 4. Participants not previously treated for AK on the current treatment area of the face or scalp in the last 6 months. However, previous AK treatment in other small areas (up to 25\^cm2) in the last greater than \>1 to less than \<6 months is allowed. 5. Females must be postmenopausal (A female said to be postmenopausal should be \>45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of child-bearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive intercourse. 6. Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment. 7. All participants must agree not to donate sperm or eggs from screening through 90 days following their last dose of study treatment. 8. Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0 prior to dose administration. 9. Willing to avoid excessive sun or UV (ultraviolet light) light exposure to the face or scalp.
Exclusion criteria
1. Clinically atypical and/or rapidly changing AK lesions. 2. Location of the treatment area is within 5 cm of an incompletely healed wound or a suspected basal cell carcinoma (BCC)/squamous cell carcinoma (SCC). 3. Skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., open wounds, scarring) in the treatment area that might interfere with the study results or suppose an unacceptable risk. 4. History of sensitivity to any of the ingredients in the tirbanibulin formulation. 5. Participated in a clinical 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. 6. Participants with a history of tirbanibulin treatment for AK lesions and participants who are currently on tirbanibulin treatment for AK lesions. 7. Use of immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/ interferon inducers and systemic immunosuppressive agents (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab) within 4 weeks prior to the Screening visit, except for organ transplant recipients under stable immunosuppressive therapy for 6 months. 8. Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit. 9. Use of the following therapies and/or medications within 2 weeks prior to the Screening Visit: * Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area * Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area * Topical salves (nonmedicated/nonirritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area. 10. Females who are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57 | At Day 57 | TSQM-9 was a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | At Day 8 | Likert scale was an instrument used to measure the individual's degree of agreement and disagreement with a variety of statements about some attitude, options, or their feelings. In this study, the product's organoleptic properties are evaluated with Likert scale. The questionnaire was built with questions related to the product's characteristics namely appearance, color, convenience, texture, smell, and the feelings experienced during drug application. The Likert scale offers 7 possible answers, from totally agree,' In agreement, Somewhat agree, Neither agree nor disagree, Something in disagreement, In disagreement and totally in disagreement. |
| Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57 | At Day 57 | TSQM 1.4 was a 14-item robust instrument that psychometrically evaluates the treatment satisfaction of the administered medication. The instrument is designed with 4 scales consisting of 14 questions. These 14 questions were derived from an original set of 55 questions extracted from exhaustive literature review and treatment groups through multistep iterative process. The 4 scales focused on effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. |
| Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | At Day 57 | An expert panel on consensus developed a questionnaire directed to patients consisting of 9 simple items using a qualitative modified delphi method. Expert panel agreed to ask 9 specific items; 1: Overall appearance of the skin (much worse to much improved); 2: Treatment satisfaction of skin looks (extremely dissatisfied to extremely satisfied); 3: Treatment satisfaction of skin texture (extremely dissatisfied to extremely satisfied); 4: Duration of skin reactions (much shorter to much longer); 5: rate the severity of skin reactions (much better to much worse); 6: impact on your daily activities due to skin reactions (much better to much worse); 7: rate the convenience/ease of use (much better to much worse); 8: rate your overall satisfaction (much better to much worse); 9: You need to be retreated for AK, how likely are you to consider tirbanibulin (very unlikely to very likely). |
| Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | At Day 57 | An expert panel on consensus developed a questionnaire directed to physicians consisting of 10 simple items using a qualitative modified delphi method. Expert panel agreed to ask 10 specific items-1: Overall appearance of the skin (much worse to much improved); 2: Treatment satisfaction of skin looks (extremely dissatisfied to extremely satisfied); 3: Treatment satisfaction of skin texture (extremely dissatisfied to extremely satisfied); 4: Duration of skin reactions (much shorter to much longer); 5: rate the severity of skin reactions (much better to much worse); 6: impact on patient's daily activities due to skin reactions (much better to much worse); 7: rate the convenience/ease of use (much better to much worse); 8: rate your overall satisfaction (much better to much worse); 9: patient needs to be retreated for AK, how likely to consider tirbanibulin (very unlikely to very likely);10: severity of skin photodamage in the original AK treated area (absent to severe). |
| Percentage of Participants With Complete (100%) Clearance of All Lesions Within the Application Area at Day 57 | At Day 57 | Complete clearance of all AK lesions within the application area, is defined as a reduction from baseline in the number of lesions = 100% at Day 57. Percentage of participants with complete clearance with a reduction of 100% (i.e., clearance percentage = 100% from Baseline) in the number of lesions within the application area were reported. |
| Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57 | Baseline, Day 57 | Skindex-16 was used for participants to rate skin conditions that have occurred within the previous week. The Skindex-16 consisted of 16 items that were divided into three sub-scores: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30). Participant were asked to respond on how much their skin condition bothered them in the week prior to administration of the Skindex-16. Each item was scored on a scale ranged from 0 (never bothered) to 6 (always bothered), where higher score indicated continued/more botheration. Item scores are transformed to 0 to 100 scale, and domain scores are calculated as the average of the item scores comprising the domain. Net positive changes in respective subscale scoring indicates improvement in that particular quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring indicates decrease in that particular quality of life assessment. |
| Percent Change From Baseline in Mean Number of Old and New AK Lesions at Day 57 | At Day 57 | Percent change from baseline in number of old and new AK lesions at Day 57 was reported. Number of lesions at Day 57 was calculated considering both old and new lesions, as: N lesions at Baseline - N lesions at Day 57/ N lesions at Baseline \* 100%. |
| Percentage of Participants by Olsen Characterization at Baseline and Day 57 | Baseline (Day 0) and Day 57 | The lesions in the identified treatment area will be classified based on Olsen characterization. Classification of AK lesions according to Olsen grade of baseline lesions: Olsen Grade I: Early AK appear as single or few, differently sized, rough, blurred, less visible than palpable, red, rough spots or very flat, non-edged plaques which reach into the reddish color; Olsen grade II: describes advanced AK as clearly visible and palpable, flat, and irregularly raised, with sharp or blurred boundaries, red, rough keratinized surface. If the surface is more strongly keratinized, the AK can also be white, yellow, or light brown. After scratching effects, a black or blue-black shade may appear; Olsen grade III: denotes late AK that have existed for a longer period of time and are firmly anchored on the lower surface, with an irregular, humpy surface, also wart-like and of different colors (white, brown, black). |
| Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint | Baseline, Day 8, Day 15, Day 29, and Day 57 | LC-OCT was a novel non-invasive imaging technique that enables in vivo visualization of the skin. It has been used for diagnosing and monitoring the treatment of skin disorders, including actinic keratosis. The use of LC-OCT in AK treatment progression allows for lesion classification based on histological features without the need for a biopsy. The histopathology of the skin was evaluated based on the estimated atypia score at cellular level of the LC-OCT images of clinical and subclinical lesions. Percentage of participants who performed LC-OCT for clinical and subclinical lesions assessment at each timepoint were reported. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs | From start of study administration up to Day 57 | An adverse event (AE) is as any untoward medical occurrence associated with the use of an intervention in humans after providing written informed consent for participation in the study until the end of study visit, whether considered intervention-related or not. A TEAE is defined as an AE with an onset that occurs after receiving study drug. Severity of TEAEs is graded as follows: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated. |
| Percentage of Participants With Partial Clearance (Reduction of at Least >=75% to <100%) of All Lesions Within the Application Area at Day 57 | At Day 57 | Participants with partial clearance were patients with a reduction of \>=75% (i.e., clearance percentage \<=-75% from Baseline) to \<100% in the number of lesions within the application area at final visit. |
Countries
Italy, Spain
Participant flow
Recruitment details
This study was conducted at 37 sites in Europe (7 in Italy and 30 in Spain) from 20 January 2023 to 19 January 2024.
Pre-assignment details
A total of 340 participants were screened, of which 334 participants enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Tirbanibulin 2.5 mg Participants applied tirbanibulin ointment- topically at a dose of 2.5 mg once daily for 5 consecutive days on the face or scalp. | 334 |
| Total | 334 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol deviation | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Tirbanibulin 2.5 mg |
|---|---|
| Age, Continuous | 74.9 years STANDARD_DEVIATION 8.51 |
| Race/Ethnicity, Customized Race: Caucasian | 334 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 278 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 334 |
| other Total, other adverse events | 153 / 334 |
| serious Total, serious adverse events | 0 / 334 |
Outcome results
Primary
Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57
TSQM-9 was a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.
Time frame: At Day 57
Population: Evaluable population consisted of FAS participants who completed the 57 days of observation and have the TSQM-9 assessment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tirbanibulin 2.5 mg | Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57 | Effectiveness Total Score Value | 73.64 score on a scale |
| Tirbanibulin 2.5 mg | Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57 | Convenience Total Score Value | 82.81 score on a scale |
| Tirbanibulin 2.5 mg | Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57 | Global Satisfaction Total Score Value | 76.94 score on a scale |
Secondary
Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57
Skindex-16 was used for participants to rate skin conditions that have occurred within the previous week. The Skindex-16 consisted of 16 items that were divided into three sub-scores: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30). Participant were asked to respond on how much their skin condition bothered them in the week prior to administration of the Skindex-16. Each item was scored on a scale ranged from 0 (never bothered) to 6 (always bothered), where higher score indicated continued/more botheration. Item scores are transformed to 0 to 100 scale, and domain scores are calculated as the average of the item scores comprising the domain. Net positive changes in respective subscale scoring indicates improvement in that particular quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring indicates decrease in that particular quality of life assessment.
Time frame: Baseline, Day 57
Population: Evaluable population consisted of FAS participants who completed the 57 days of observation and have the TSQM-9 assessment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tirbanibulin 2.5 mg | Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57 | Symptoms Sub-Score: Change at Day 57 | -10.49 score on a scale |
| Tirbanibulin 2.5 mg | Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57 | Emotions Sub-Score: Change at Day 57 | -11.56 score on a scale |
| Tirbanibulin 2.5 mg | Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57 | Functioning Sub-Score: Change at Day 57 | -2.49 score on a scale |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs
An adverse event (AE) is as any untoward medical occurrence associated with the use of an intervention in humans after providing written informed consent for participation in the study until the end of study visit, whether considered intervention-related or not. A TEAE is defined as an AE with an onset that occurs after receiving study drug. Severity of TEAEs is graded as follows: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated.
Time frame: From start of study administration up to Day 57
Population: Safety population consisted of FAS participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tirbanibulin 2.5 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs | Participants with TEAEs | 153 Participants |
| Tirbanibulin 2.5 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs | Severity of TEAEs: Grade 1 | 132 Participants |
| Tirbanibulin 2.5 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs | Severity of TEAEs: Grade 2 | 17 Participants |
| Tirbanibulin 2.5 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs | Severity of TEAEs: Grade 3 | 3 Participants |
| Tirbanibulin 2.5 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs | Severity of TEAEs: Grade 4 | 1 Participants |
Secondary
Percentage of Participants by Olsen Characterization at Baseline and Day 57
The lesions in the identified treatment area will be classified based on Olsen characterization. Classification of AK lesions according to Olsen grade of baseline lesions: Olsen Grade I: Early AK appear as single or few, differently sized, rough, blurred, less visible than palpable, red, rough spots or very flat, non-edged plaques which reach into the reddish color; Olsen grade II: describes advanced AK as clearly visible and palpable, flat, and irregularly raised, with sharp or blurred boundaries, red, rough keratinized surface. If the surface is more strongly keratinized, the AK can also be white, yellow, or light brown. After scratching effects, a black or blue-black shade may appear; Olsen grade III: denotes late AK that have existed for a longer period of time and are firmly anchored on the lower surface, with an irregular, humpy surface, also wart-like and of different colors (white, brown, black).
Time frame: Baseline (Day 0) and Day 57
Population: Evaluable population consisted of FAS participants who completed the 57 days of observation and have the TSQM-9 assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tirbanibulin 2.5 mg | Percentage of Participants by Olsen Characterization at Baseline and Day 57 | Olsen Grade I: Day 57 | 39.33 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants by Olsen Characterization at Baseline and Day 57 | Olsen Grade II: Baseline | 8.84 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants by Olsen Characterization at Baseline and Day 57 | Olsen Grade II: Day 57 | 3.66 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants by Olsen Characterization at Baseline and Day 57 | Olsen Grade I: Baseline | 62.80 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants by Olsen Characterization at Baseline and Day 57 | Olsen Grade III: Baseline | 0.0 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants by Olsen Characterization at Baseline and Day 57 | Olsen Grade III: Day 57 | 0.30 Percentage of participants |
Secondary
Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint
LC-OCT was a novel non-invasive imaging technique that enables in vivo visualization of the skin. It has been used for diagnosing and monitoring the treatment of skin disorders, including actinic keratosis. The use of LC-OCT in AK treatment progression allows for lesion classification based on histological features without the need for a biopsy. The histopathology of the skin was evaluated based on the estimated atypia score at cellular level of the LC-OCT images of clinical and subclinical lesions. Percentage of participants who performed LC-OCT for clinical and subclinical lesions assessment at each timepoint were reported.
Time frame: Baseline, Day 8, Day 15, Day 29, and Day 57
Population: LC-OCT population consisted of FAS participants who performed at least one valid LC-OCT assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tirbanibulin 2.5 mg | Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint | At Baseline | 100.00 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint | At Day 8 | 91.67 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint | At Day 15 | 91.67 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint | At Day 57 | 100.00 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint | At Day 29 | 91.67 Percentage of participants |
Secondary
Percentage of Participants With Complete (100%) Clearance of All Lesions Within the Application Area at Day 57
Complete clearance of all AK lesions within the application area, is defined as a reduction from baseline in the number of lesions = 100% at Day 57. Percentage of participants with complete clearance with a reduction of 100% (i.e., clearance percentage = 100% from Baseline) in the number of lesions within the application area were reported.
Time frame: At Day 57
Population: Evaluable population consisted of FAS participants who completed the 57 days of observation and have the TSQM-9 assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tirbanibulin 2.5 mg | Percentage of Participants With Complete (100%) Clearance of All Lesions Within the Application Area at Day 57 | 54.27 Percentage of participants |
Secondary
Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8
Likert scale was an instrument used to measure the individual's degree of agreement and disagreement with a variety of statements about some attitude, options, or their feelings. In this study, the product's organoleptic properties are evaluated with Likert scale. The questionnaire was built with questions related to the product's characteristics namely appearance, color, convenience, texture, smell, and the feelings experienced during drug application. The Likert scale offers 7 possible answers, from totally agree,' In agreement, Somewhat agree, Neither agree nor disagree, Something in disagreement, In disagreement and totally in disagreement.
Time frame: At Day 8
Population: Evaluable population consisted of FAS participants who completed the 57 days of observation and have the TSQM-9 assessment. Here, Overall number of Participants signifies participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The general appearance of the product is good: Something in disagreement | 0.31 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The general appearance of the product is good: In disagreement | 0.61 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The general appearance of the product is good: Totally in disagreement | 0 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The overall assessment of the product is very satisfactory: Totally agree | 36.70 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The overall assessment of the product is very satisfactory: In agreement | 38.53 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The overall assessment of the product is very satisfactory: Neither agree nor disagree | 10.40 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The overall assessment of the product is very satisfactory: Something in disagreement | 1.53 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The overall assessment of the product is very satisfactory: In disagreement | 3.36 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The overall assessment of the product is very satisfactory: Totally in disagreement | 1.22 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | I would recommend the product: Totally agree | 34.86 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | I would recommend the product: In agreement | 33.64 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | I would recommend the product: Somewhat agree | 5.81 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | I would recommend the product: Neither agree nor disagree | 18.04 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | I would recommend the product: Something in disagreement | 1.22 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | I would recommend the product: In disagreement | 3.06 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | I would recommend the product: Totally in disagreement | 3.36 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The color of the product is nice: Totally agree | 36.70 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The color of the product is nice: In agreement | 36.09 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The color of the product is nice: Somewhat agree | 5.81 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The color of the product is nice: Neither agree nor disagree | 20.80 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The color of the product is nice: Something in disagreement | 0 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The color of the product is nice: In disagreement | 0.61 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The color of the product is nice: Totally in disagreement | 0 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is nice: Totally agree | 48.93 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is nice: Somewhat agree | 5.20 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is nice: Neither agree nor disagree | 4.28 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is nice: Something in disagreement | 0.61 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is nice: In disagreement | 0.61 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is nice: Totally in disagreement | 0 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is watery: Totally agree | 12.84 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is watery: In agreement | 18.65 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is watery: Somewhat agree | 9.79 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is watery: Neither agree nor disagree | 15.90 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is watery: Totally in disagreement | 14.68 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is oily: Totally agree | 11.31 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is oily: In agreement | 15.90 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is oily: Somewhat agree | 9.48 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is oily: Neither agree nor disagree | 16.82 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is oily: Something in disagreement | 6.73 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is oily: In disagreement | 20.49 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is oily: Totally in disagreement | 19.27 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is creamy: Totally agree | 40.06 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is creamy: In agreement | 41.28 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is creamy: Somewhat agree | 7.03 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is creamy: Something in disagreement | 1.53 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is creamy: In disagreement | 1.83 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is creamy: Totally in disagreement | 0.92 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The skin was greasy after applying the treatment: Totally agree | 12.84 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The skin was greasy after applying the treatment: In agreement | 25.08 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The skin was greasy after applying the treatment: Somewhat agree | 14.68 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The skin was greasy after applying the treatment: Neither agree nor disagree | 8.56 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The skin was greasy after applying the treatment: Something in disagreement | 3.98 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The skin was greasy after applying the treatment: In disagreement | 17.13 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The skin was greasy after applying the treatment: Totally in disagreement | 17.74 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The smell of the product is pleasant: Totally agree | 23.85 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The smell of the product is pleasant: In agreement | 23.55 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The smell of the product is pleasant: Somewhat agree | 7.65 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The smell of the product is pleasant: Something in disagreement | 0.61 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The smell of the product is pleasant: In disagreement | 0.92 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The smell of the product is pleasant: Totally in disagreement | 0.92 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product feels pleasant on the skin: Totally agree | 27.22 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product feels pleasant on the skin: In agreement | 30.28 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product feels pleasant on the skin: Somewhat agree | 10.70 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product feels pleasant on the skin: Neither agree nor disagree | 21.10 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product feels pleasant on the skin: Something in disagreement | 1.83 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product feels pleasant on the skin: In disagreement | 5.50 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product feels pleasant on the skin: Totally in disagreement | 3.36 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The feel of the product on the skin is refreshing: Totally agree | 18.35 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The feel of the product on the skin is refreshing: In agreement | 20.80 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The feel of the product on the skin is refreshing: Somewhat agree | 11.31 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The feel of the product on the skin is refreshing: Neither agree nor disagree | 22.94 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The feel of the product on the skin is refreshing: Something in disagreement | 5.81 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The feel of the product on the skin is refreshing: In disagreement | 10.09 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The feel of the product on the skin is refreshing: Totally in disagreement | 10.70 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product offers a protective feeling: Totally agree | 20.80 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product offers a protective feeling: In agreement | 25.38 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product offers a protective feeling: Somewhat agree | 9.48 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product offers a protective feeling: Neither agree nor disagree | 30.28 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product offers a protective feeling: Something in disagreement | 3.06 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product offers a protective feeling: In disagreement | 5.81 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product offers a protective feeling: Totally in disagreement | 5.20 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product is easy to apply: Totally agree | 66.36 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product is easy to apply: In agreement | 27.22 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product is easy to apply: Somewhat agree | 3.67 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product is easy to apply: Neither agree nor disagree | 0.92 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product is easy to apply: Something in disagreement | 0.92 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product is easy to apply: In disagreement | 0.31 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product is easy to apply: Totally in disagreement | 0.61 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product can be distributed evenly and easily: Somewhat agree | 4.28 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product can be distributed evenly and easily: Neither agree nor disagree | 0.61 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product can be distributed evenly and easily: Something in disagreement | 0.92 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product can be distributed evenly and easily: Totally in disagreement | 0 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | Product remains on application area, without spreading to neighboring areas: Totally agree | 57.19 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | Product remains on application area, without spreading to neighboring areas: In agreement | 29.97 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | Product remains on application area, without spreading to neighboring areas: Somewhat agree | 6.12 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | Product remains on application area, without spreading to neighboring areas: Neither agree/ disagree | 2.75 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | Product remains on application area without spreading to neighboring areas:Something in disagreement | 2.14 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | Product remains on application area, without spreading to neighboring areas: In disagreement | 0.61 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | Product remains on application area, without spreading to neighboring areas: Totally in disagreement | 1.22 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product packaging is practical: Totally agree | 50.76 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product packaging is practical: In agreement | 33.94 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product packaging is practical: Somewhat agree | 6.12 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product packaging is practical: Totally in disagreement | 0.61 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The general appearance of the product is good: Totally agree | 52.60 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The general appearance of the product is good: In agreement | 38.23 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The general appearance of the product is good: Somewhat agree | 3.06 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The general appearance of the product is good: Neither agree nor disagree | 5.20 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The overall assessment of the product is very satisfactory: Somewhat agree | 8.26 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is nice: In agreement | 40.37 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is watery: Something in disagreement | 8.26 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is watery: In disagreement | 19.88 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The texture of the product is creamy: Neither agree nor disagree | 7.34 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The smell of the product is pleasant: Neither agree nor disagree | 42.51 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product can be distributed evenly and easily: Totally agree | 64.53 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product can be distributed evenly and easily: In agreement | 29.05 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product can be distributed evenly and easily: In disagreement | 0.61 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product packaging is practical: Neither agree nor disagree | 3.06 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product packaging is practical: Something in disagreement | 2.14 Percentage of participants |
| Tirbanibulin 2.5 mg | Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | The product packaging is practical: In disagreement | 3.36 Percentage of participants |
Secondary
Percentage of Participants With Partial Clearance (Reduction of at Least >=75% to <100%) of All Lesions Within the Application Area at Day 57
Participants with partial clearance were patients with a reduction of \>=75% (i.e., clearance percentage \<=-75% from Baseline) to \<100% in the number of lesions within the application area at final visit.
Time frame: At Day 57
Population: Evaluable population consisted of FAS participants who completed the 57 days of observation and have the TSQM-9 assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tirbanibulin 2.5 mg | Percentage of Participants With Partial Clearance (Reduction of at Least >=75% to <100%) of All Lesions Within the Application Area at Day 57 | 22.56 Percentage of participants |
Secondary
Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57
An expert panel on consensus developed a questionnaire directed to patients consisting of 9 simple items using a qualitative modified delphi method. Expert panel agreed to ask 9 specific items; 1: Overall appearance of the skin (much worse to much improved); 2: Treatment satisfaction of skin looks (extremely dissatisfied to extremely satisfied); 3: Treatment satisfaction of skin texture (extremely dissatisfied to extremely satisfied); 4: Duration of skin reactions (much shorter to much longer); 5: rate the severity of skin reactions (much better to much worse); 6: impact on your daily activities due to skin reactions (much better to much worse); 7: rate the convenience/ease of use (much better to much worse); 8: rate your overall satisfaction (much better to much worse); 9: You need to be retreated for AK, how likely are you to consider tirbanibulin (very unlikely to very likely).
Time frame: At Day 57
Population: Evaluable population consisted of FAS participants who completed the 57 days of observation and have the TSQM-9 assessment. Here, number analyzed signifies participants who were evaluable at specific category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Overall appearance of the skin: Much worse | 0.31 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Overall appearance of the skin: Somewhat worse | 0.31 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Overall appearance of the skin: No change | 6.92 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Overall appearance of the skin: Somewhat improved | 24.84 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Overall appearance of the skin: Much improved | 67.61 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin looks: Extremely Dissatisfied | 0 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin looks: Very Dissatisfied | 0.63 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin looks: Very Satisfied | 30.19 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin looks: Extremely Satisfied | 33.33 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin texture: Extremely Dissatisfied | 0 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin texture: Very Dissatisfied | 1.25 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin texture: Dissatisfied | 2.80 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin texture: Somewhat Satisfied | 7.17 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin texture: Satisfied | 30.84 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin texture: Very Satisfied | 27.73 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Duration of skin reactions: Much longer | 3.76 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate the severity of skin reactions: Much better | 51.34 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate the severity of skin reactions: Somewhat better | 21.93 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Impact on your daily activities due to skin reactions: Somewhat worse | 3.70 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate the convenience/ease of use: Much better | 57.97 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate your overall satisfaction: Much better | 60.29 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate your overall satisfaction: Somewhat better | 21.53 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate your overall satisfaction: Same | 13.40 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate your overall satisfaction: Somewhat worse | 3.83 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate your overall satisfaction: Much worse | 0.96 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | You need to be retreated for AK, how likely to consider tirbanibulin: Very unlikely | 3.66 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | You need to be retreated for AK, how likely to consider tirbanibulin: Very likely | 67.68 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin looks: Dissatisfied | 2.83 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin looks: Somewhat Satisfied | 7.23 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin looks: Satisfied | 25.79 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Treatment satisfaction of skin texture: Extremely Satisfied | 30.22 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Duration of skin reactions: Much shorter | 44.62 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Duration of skin reactions: Somewhat shorter | 23.66 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Duration of skin reactions: Same | 18.82 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Duration of skin reactions: Somewhat longer | 9.14 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate the severity of skin reactions: Same | 16.58 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate the severity of skin reactions: Somewhat worse | 8.02 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate the severity of skin reactions: Much worse | 2.14 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Impact on your daily activities due to skin reactions: Much better | 49.74 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Impact on your daily activities due to skin reactions: Somewhat better | 13.76 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Impact on your daily activities due to skin reactions: Same | 31.75 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Impact on your daily activities due to skin reactions: Much worse | 1.06 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate the convenience/ease of use: Somewhat better | 19.81 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate the convenience/ease of use: Same | 19.81 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate the convenience/ease of use: Somewhat worse | 1.93 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | Rate the convenience/ease of use: Much worse | 0.48 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | You need to be retreated for AK, how likely to consider tirbanibulin: Somewhat unlikely | 2.44 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | You need to be retreated for AK, how likely to consider tirbanibulin: Neutral | 7.62 Percentage of patients |
| Tirbanibulin 2.5 mg | Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | You need to be retreated for AK, how likely to consider tirbanibulin: Somewhat likely | 18.60 Percentage of patients |
Secondary
Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57
An expert panel on consensus developed a questionnaire directed to physicians consisting of 10 simple items using a qualitative modified delphi method. Expert panel agreed to ask 10 specific items-1: Overall appearance of the skin (much worse to much improved); 2: Treatment satisfaction of skin looks (extremely dissatisfied to extremely satisfied); 3: Treatment satisfaction of skin texture (extremely dissatisfied to extremely satisfied); 4: Duration of skin reactions (much shorter to much longer); 5: rate the severity of skin reactions (much better to much worse); 6: impact on patient's daily activities due to skin reactions (much better to much worse); 7: rate the convenience/ease of use (much better to much worse); 8: rate your overall satisfaction (much better to much worse); 9: patient needs to be retreated for AK, how likely to consider tirbanibulin (very unlikely to very likely);10: severity of skin photodamage in the original AK treated area (absent to severe).
Time frame: At Day 57
Population: Evaluable population consisted of FAS participants who completed the 57 days of observation and have the TSQM-9 assessment. Here, Overall number of Participants signifies participants who were evaluable for this outcome and number analyzed signifies participants who were evaluable at specific category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Overall appearance of the skin:Much worse | 1.23 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Overall appearance of the skin: Somewhat worse | 1.23 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Overall appearance of the skin: Somewhat improved | 21.78 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Overall appearance of the skin: Much improved | 74.54 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin looks: Extremely Dissatisfied | 0.31 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin looks: Very Dissatisfied | 0.31 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin looks: Dissatisfied | 0.31 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin looks: Somewhat Satisfied | 6.79 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin looks: Satisfied | 25.31 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin texture: Very Dissatisfied | 0.31 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin texture: Dissatisfied | 0.92 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin texture: Extremely Satisfied | 31.08 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Duration of skin reactions: Much shorter | 60.09 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Duration of skin reactions: Somewhat shorter | 27.35 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate the severity of skin reactions: Much better | 64.86 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate the severity of skin reactions: Somewhat better | 22.07 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate the severity of skin reactions: Same | 9.01 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate the severity of skin reactions: Somewhat worse | 3.60 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate the convenience/ease of use: Much better | 65.78 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate the convenience/ease of use: Somewhat better | 25.33 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate the convenience/ease of use: Same | 5.33 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate your overall satisfaction: Somewhat better | 37.00 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate your overall satisfaction: Same | 11.01 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate your overall satisfaction: Somewhat worse | 0.88 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate your overall satisfaction: Much worse | 0.44 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Patient needs to be retreated for AK, how likely to consider tirbanibulin: Very unlikely | 3.68 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Patient needs to be retreated for AK, how likely to consider tirbanibulin: Very likely | 64.11 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Severity of skin photodamage in the original AK treated area: Absent | 24.85 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Severity of skin photodamage in the original AK treated area: Mild | 46.63 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Severity of skin photodamage in the original AK treated area: Severe | 0.92 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Overall appearance of the skin: No change | 1.23 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin looks: Very Satisfied | 31.48 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin looks: Extremely Satisfied | 35.49 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin texture: Extremely Dissatisfied | 0.31 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin texture: Somewhat Satisfied | 6.77 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin texture: Satisfied | 27.69 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Treatment satisfaction of skin texture: Very Satisfied | 32.92 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Duration of skin reactions: Same | 8.52 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Duration of skin reactions: Somewhat longer | 3.14 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Duration of skin reactions: Much longer | 0.90 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate the severity of skin reactions: Much worse | 0.45 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Impact on patient's daily activities due to skin reactions: Much better | 59.81 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Impact on patient's daily activities due to skin reactions: Somewhat better | 19.63 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Impact on patient's daily activities due to skin reactions: Same | 19.63 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Impact on patient's daily activities due to skin reactions: Somewhat worse | 0.47 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Impact on patient's daily activities due to skin reactions: Much worse | 0.47 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate the convenience/ease of use: Somewhat worse | 3.56 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate the convenience/ease of use: Much worse | 0 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Rate your overall satisfaction: Much better | 50.66 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Patient needs to be retreated for AK, how likely to consider tirbanibulin: Somewhat unlikely | 1.53 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Patient needs to be retreated for AK, how likely to consider tirbanibulin: Neutral | 7.67 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Patient needs to be retreated for AK, how likely to consider tirbanibulin: Somewhat likely | 23.01 Percentage of physician |
| Tirbanibulin 2.5 mg | Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | Severity of skin photodamage in the original AK treated area: Moderate | 27.61 Percentage of physician |
Secondary
Percent Change From Baseline in Mean Number of Old and New AK Lesions at Day 57
Percent change from baseline in number of old and new AK lesions at Day 57 was reported. Number of lesions at Day 57 was calculated considering both old and new lesions, as: N lesions at Baseline - N lesions at Day 57/ N lesions at Baseline \* 100%.
Time frame: At Day 57
Population: Evaluable population consisted of FAS participants who completed the 57 days of observation and have the TSQM-9 assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tirbanibulin 2.5 mg | Percent Change From Baseline in Mean Number of Old and New AK Lesions at Day 57 | -82.22 Percent change | Standard Deviation 26.367 |
Secondary
Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57
TSQM 1.4 was a 14-item robust instrument that psychometrically evaluates the treatment satisfaction of the administered medication. The instrument is designed with 4 scales consisting of 14 questions. These 14 questions were derived from an original set of 55 questions extracted from exhaustive literature review and treatment groups through multistep iterative process. The 4 scales focused on effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction.
Time frame: At Day 57
Population: Evaluable population consisted of FAS participants who completed the 57 days of observation and have the TSQM-9 assessment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tirbanibulin 2.5 mg | Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57 | Effectiveness score value at Day 57 | 73.64 score on a scale |
| Tirbanibulin 2.5 mg | Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57 | Global satisfaction score value at Day 57 | 76.94 score on a scale |
| Tirbanibulin 2.5 mg | Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57 | Convenience score value at Day 57 | 82.81 score on a scale |
| Tirbanibulin 2.5 mg | Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57 | Side Effects score value at Day 57 | 97.47 score on a scale |