Keratosis, Actinic
Conditions
Brief summary
The purpose of the study is to evaluate the safety, tolerability and treatment effect of tirbanibulin ointment 1% when applied to a field of approximately 100 cm\^2 on the face or balding scalp.
Interventions
Applied topically for 5 days over a field of approximately 100 cm\^2 on the face or balding scalp with AK.
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
* Having a treatment field (TF) on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that measures approximately 100 cm\^2 (eg, mid face) and contains 4 to 12 clinically typical, visible, and discrete actinic keratosis (AK) lesions within the TF * Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during the study * Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provided written informed consent in accordance with institutional and regulatory guidelines
Exclusion criteria
* Presence in the TF of 1. Clinically atypical and/or rapidly changing AK lesions in the TF 2. Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions) and/or cutaneous horn 3. Confluent AK lesions (ie, non-discrete lesions defined as per inclusion criteria) 4. History of invasive squamous cell carcinoma (SCC), Bowen's disease, basal cell carcinoma (BCC), or other malignant tumors in the TF 5. Any other dermatological disease that causes difficulty with examination * Previous treatment with tirbanibulin ointment 1%. * Anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day 57 * Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the TF or within 2 cm of the TF, within 8 weeks prior to the Screening visit * Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | Baseline, Day 8 | Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 8 was reported. |
| Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline, Day 5 | Local tolerability score was evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. Number of participants categorized by local tolerability score by visit for each individual signs (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) at Day 5 were reported. |
| Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline, Day 8 | Local tolerability score was evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. Number of participants categorized by local tolerability score by visit for each individual signs (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) at Day 8 were reported. |
| Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline, Day 15 | Local tolerability score was evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. Number of participants categorized by local tolerability score by visit for each individual signs (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) at Day 15 were reported. |
| Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline, Day 29 | Local tolerability score was evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. Number of participants categorized by local tolerability score by visit for each individual signs (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) at Day 29 were reported. |
| Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline, Day 57 | Local tolerability score was evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. Number of participants categorized by local tolerability score by visit for each individual signs (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) at Day 57 were reported. |
| Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline, Maximum post-baseline (up to Day 57) | Maximum local tolerability score post baseline was defined as the highest grade of any LSR reported at any post-baseline visits for a participant. Local tolerability score was assessed for signs erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. If a participant maximum individual sign local tolerability score stayed at 0 throughout the study, the participant was considered censored at last local tolerability score observation. Number of participants with maximum local tolerability score for each individual signs including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration were reported. |
| Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration | Baseline up to Day 57 | Time to maximum local tolerability score (in days) for each individual sign was calculated as \[Date of first post-baseline occurrence of maximum local tolerability score for this individual sign - Date of first dose\]. If a participant maximum individual sign LTA score stays at 0 throughout the study, the participants was considered censored at their last LTA score observation. Maximum local tolerability score was assessed for each signs using a 4 - point scale of 0 - 3, where 0 = absent, 1= mild, 2= moderate and 3 = severe. The higher score indicates severe symptoms. Time to maximum local tolerability score for erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration was reported. |
| Local Tolerability Signs Total Composite Score by Visit at Day 5 | Baseline, Day 5 | Local tolerability signs composite score by visit was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Local tolerability signs total composite score assessed from baseline up to Day 5 was reported. |
| Local Tolerability Signs Total Composite Score by Visit at Day 8 | Baseline, Day 8 | Local tolerability signs composite score by visit was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Local tolerability signs total composite score by visit at Day 8 was reported. |
| Local Tolerability Signs Total Composite Score by Visit at Day 15 | Baseline, Day 15 | Local tolerability signs composite score by visit was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Local tolerability signs total composite score by visit at Day 15 was reported. |
| Local Tolerability Signs Total Composite Score by Visit at Day 29 | Baseline, Day 29 | Local tolerability signs composite score by visit was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Local tolerability signs total composite score by visit at Day 29 was reported. |
| Local Tolerability Signs Total Composite Score by Visit at Day 57 | Baseline, Day 57 | Local tolerability signs composite score by visit was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Local tolerability signs total composite score by visit at Day 57 was reported. |
| Maximum Local Tolerability Signs Total Composite Score Post Baseline | Baseline, Maximum post-baseline (up to Day 57) | The maximum local tolerability signs composite score across visits was derived as the maximum local tolerability composite score observed post-baseline. Local tolerability signs composite score was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Maximum local tolerability signs total composite score post baseline was reported. |
| Time to Maximum Local Tolerability Total Composite Score | Baseline up to Day 57 | Time to maximum composite local tolerability score (in days) was calculated as (Date of first post-baseline occurrence of maximum composite local tolerability score - Date of first dose). The maximum local tolerability signs composite score across visits was derived as the maximum local tolerability composite score observed post-baseline. Local tolerability signs composite score was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. If a participant's maximum composite local tolerability score stays at 0 throughout the study, the participant was considered censored at their last local tolerability score observation. Time to maximum local tolerability total composite score was reported. |
| Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | Baseline, Day 5 | Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 5 was reported. |
| Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | Baseline, Day 15 | Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 15 was reported. |
| Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | Baseline, Day 29 | Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 29 was reported. |
| Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | Baseline, Day 57 | Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 57 was reported. |
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) | Baseline up to Day 57 | TEAEs were defined as either those adverse events (AEs) with an onset after dosing or those pre-existing conditions that worsened after dosing. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an Investigational Product. An SAE with any untoward medical occurrence that at any dose, resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect in the child of a participant who was exposed to the study drug, or any other medically important event that may jeopardize the patient or require intervention to prevent one of the other outcomes. AESI's included in this study were skin cancers (including basal cell carcinoma, squamous cell carcinoma, and melanoma) based on their relevance for the current intended use. TEAEs included both serious and non-serious AEs. |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Baseline up to Day 57 | Laboratory parameters included blood chemistry, hamatology, and urinalysis. Clinically significant laboratory abnormalities assessment was based on Investigator interpretation. Number of participants with clinically significant abnormalities in laboratory parameters (included hematology, blood chemistry and urinalysis) were reported. |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Baseline up to Day 57 | Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinically significant vital signs abnormalities assessment was based on Investigator interpretation. Number of participants with clinically significant abnormalities in vital signs were reported. |
| Number of Participants With Clinically Significant Abnormalities in Physical Examination | Baseline up to Day 57 | Physical examination included weight and height measurements. Clinically significant physical examination abnormalities assessment was based on Investigator interpretation. Number of participants with clinically significant abnormalities in physical examination were reported. |
| Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | Baseline up to Day 57 | ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Clinically significant ECGs abnormalities assessment was based on Investigator interpretation. Number of participants with clinically significant abnormalities in ECG were reported. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 20 sites in the United States from 28 June 2022 to 28 December 2022.
Pre-assignment details
A total 105 participants were enrolled in the study to receive study treatment. At least 50 percent (%) of the participants were 65 years old (65%) and 71 participants were treated on the face and 34 participants on the scalp. The study consisted of a 4-week (28-day) Screening Period, a 5-day Treatment Period, and a Response Assessment Period of approximately 7 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Tirbanibulin (Klisyri®) Participants applied tirbanibulin ointment 1% topically once daily on Day 1 for 5 days over a field of approximately 100 cm\^2 on the face or balding scalp with AK. | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Tirbanibulin (Klisyri®) |
|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of AK lesions at baseline | 7.7 Number of AK lesions STANDARD_DEVIATION 2.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 105 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 105 |
| other Total, other adverse events | 29 / 105 |
| serious Total, serious adverse events | 2 / 105 |
Outcome results
Primary
Local Tolerability Signs Total Composite Score by Visit at Day 15
Local tolerability signs composite score by visit was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Local tolerability signs total composite score by visit at Day 15 was reported.
Time frame: Baseline, Day 15
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Local Tolerability Signs Total Composite Score by Visit at Day 15 | Baseline | 0.5 Score on a Scale | Standard Deviation 1.06 |
| Tirbanibulin (Klisyri®) | Local Tolerability Signs Total Composite Score by Visit at Day 15 | At Day 15 | 1.6 Score on a Scale | Standard Deviation 1.46 |
Primary
Local Tolerability Signs Total Composite Score by Visit at Day 29
Local tolerability signs composite score by visit was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Local tolerability signs total composite score by visit at Day 29 was reported.
Time frame: Baseline, Day 29
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Local Tolerability Signs Total Composite Score by Visit at Day 29 | At Day 29 | 0.5 Score on a Scale | Standard Deviation 0.8 |
| Tirbanibulin (Klisyri®) | Local Tolerability Signs Total Composite Score by Visit at Day 29 | Baseline | 0.5 Score on a Scale | Standard Deviation 1.06 |
Primary
Local Tolerability Signs Total Composite Score by Visit at Day 5
Local tolerability signs composite score by visit was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Local tolerability signs total composite score assessed from baseline up to Day 5 was reported.
Time frame: Baseline, Day 5
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Local Tolerability Signs Total Composite Score by Visit at Day 5 | Baseline | 0.5 Score on a scale | Standard Deviation 1.06 |
| Tirbanibulin (Klisyri®) | Local Tolerability Signs Total Composite Score by Visit at Day 5 | At Day 5 | 2.6 Score on a scale | Standard Deviation 1.67 |
Primary
Local Tolerability Signs Total Composite Score by Visit at Day 57
Local tolerability signs composite score by visit was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Local tolerability signs total composite score by visit at Day 57 was reported.
Time frame: Baseline, Day 57
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Local Tolerability Signs Total Composite Score by Visit at Day 57 | Baseline | 0.5 Score on a Scale | Standard Deviation 1.06 |
| Tirbanibulin (Klisyri®) | Local Tolerability Signs Total Composite Score by Visit at Day 57 | At Day 57 | 0.1 Score on a Scale | Standard Deviation 0.36 |
Primary
Local Tolerability Signs Total Composite Score by Visit at Day 8
Local tolerability signs composite score by visit was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Local tolerability signs total composite score by visit at Day 8 was reported.
Time frame: Baseline, Day 8
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Local Tolerability Signs Total Composite Score by Visit at Day 8 | Baseline | 0.5 Score on a Scale | Standard Deviation 1.06 |
| Tirbanibulin (Klisyri®) | Local Tolerability Signs Total Composite Score by Visit at Day 8 | At Day 8 | 3.8 Score on a Scale | Standard Deviation 2.25 |
Primary
Maximum Local Tolerability Signs Total Composite Score Post Baseline
The maximum local tolerability signs composite score across visits was derived as the maximum local tolerability composite score observed post-baseline. Local tolerability signs composite score was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. Maximum local tolerability signs total composite score post baseline was reported.
Time frame: Baseline, Maximum post-baseline (up to Day 57)
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Maximum Local Tolerability Signs Total Composite Score Post Baseline | Baseline | 0.5 Score on a scale | Standard Deviation 1.06 |
| Tirbanibulin (Klisyri®) | Maximum Local Tolerability Signs Total Composite Score Post Baseline | At Maximum post-baseline (up to Day 57) | 4.1 Score on a scale | Standard Deviation 2.12 |
Primary
Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15
Local tolerability score was evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. Number of participants categorized by local tolerability score by visit for each individual signs (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) at Day 15 were reported.
Time frame: Baseline, Day 15
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Erythema | Grade 0 | 81 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Erythema | Grade 1 | 19 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Erythema | Grade 2 | 5 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Erythema | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Erythema | Grade 0 | 33 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Erythema | Grade 1 | 61 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Erythema | Grade 2 | 7 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Erythema | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Flaking/Scaling | Grade 0 | 84 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Flaking/Scaling | Grade 1 | 17 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Flaking/Scaling | Grade 2 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Flaking/Scaling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Flaking/Scaling | Grade 0 | 54 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Flaking/Scaling | Grade 1 | 33 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Flaking/Scaling | Grade 2 | 13 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Flaking/Scaling | Grade 3 | 1 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Crusting | Grade 0 | 103 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Crusting | Grade 1 | 2 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Crusting | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Crusting | Grade 0 | 86 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Crusting | Grade 1 | 12 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Crusting | Grade 2 | 3 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Swelling | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Swelling | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Swelling | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Swelling | Grade 0 | 96 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Swelling | Grade 1 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Swelling | Grade 2 | 1 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Vesiculation/Pustulation | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Vesiculation/Pustulation | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Vesiculation/Pustulation | Grade 0 | 101 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Vesiculation/Pustulation | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Erosion/Ulceration | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Erosion/Ulceration | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Erosion/Ulceration | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | Baseline: Erosion/Ulceration | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Erosion/Ulceration | Grade 0 | 100 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Erosion/Ulceration | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Erosion/Ulceration | Grade 2 | 1 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 | At Day 15: Erosion/Ulceration | Grade 3 | 0 Participants |
Primary
Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29
Local tolerability score was evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. Number of participants categorized by local tolerability score by visit for each individual signs (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) at Day 29 were reported.
Time frame: Baseline, Day 29
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Erythema | Grade 0 | 81 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Erythema | Grade 1 | 19 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Erythema | Grade 2 | 5 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Erythema | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Erythema | Grade 0 | 74 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Erythema | Grade 1 | 26 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Erythema | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Erythema | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Flaking/Scaling | Grade 0 | 84 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Flaking/Scaling | Grade 1 | 17 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Flaking/Scaling | Grade 2 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Flaking/Scaling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Flaking/Scaling | Grade 0 | 84 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Flaking/Scaling | Grade 1 | 16 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Flaking/Scaling | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Flaking/Scaling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Crusting | Grade 0 | 103 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Crusting | Grade 1 | 2 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Crusting | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Crusting | Grade 0 | 97 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Crusting | Grade 1 | 3 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Crusting | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Swelling | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Swelling | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Swelling | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Swelling | Grade 0 | 98 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Swelling | Grade 1 | 2 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Swelling | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Vesiculation/Pustulation | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Vesiculation/Pustulation | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Vesiculation/Pustulation | Grade 0 | 100 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Vesiculation/Pustulation | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Erosion/Ulceration | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Erosion/Ulceration | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Erosion/Ulceration | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | Baseline: Erosion/Ulceration | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Erosion/Ulceration | Grade 0 | 100 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Erosion/Ulceration | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Erosion/Ulceration | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 | At Day 29: Erosion/Ulceration | Grade 3 | 0 Participants |
Primary
Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5
Local tolerability score was evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. Number of participants categorized by local tolerability score by visit for each individual signs (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) at Day 5 were reported.
Time frame: Baseline, Day 5
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Erythema | Grade 0 | 81 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Erythema | Grade 1 | 19 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Erythema | Grade 2 | 5 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Erythema | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Erythema | Grade 0 | 13 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Erythema | Grade 1 | 41 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Erythema | Grade 2 | 44 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Erythema | Grade 3 | 3 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Flaking/Scaling | Grade 0 | 84 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Flaking/Scaling | Grade 1 | 17 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Flaking/Scaling | Grade 2 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Flaking/Scaling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Flaking/Scaling | Grade 0 | 44 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Flaking/Scaling | Grade 1 | 38 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Flaking/Scaling | Grade 2 | 19 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Flaking/Scaling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Crusting | Grade 0 | 103 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Crusting | Grade 1 | 2 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Crusting | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Crusting | Grade 0 | 90 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Crusting | Grade 1 | 9 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Crusting | Grade 2 | 2 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Swelling | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Swelling | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Swelling | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Swelling | Grade 0 | 73 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Swelling | Grade 1 | 25 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Swelling | Grade 2 | 3 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Vesiculation/Pustulation | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Vesiculation/Pustulation | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Vesiculation/Pustulation | Grade 0 | 98 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Vesiculation/Pustulation | Grade 1 | 3 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Erosion/Ulceration | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Erosion/Ulceration | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Erosion/Ulceration | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | Baseline: Erosion/Ulceration | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Erosion/Ulceration | Grade 0 | 97 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Erosion/Ulceration | Grade 1 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Erosion/Ulceration | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 | At Day 5: Erosion/Ulceration | Grade 3 | 0 Participants |
Primary
Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57
Local tolerability score was evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. Number of participants categorized by local tolerability score by visit for each individual signs (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) at Day 57 were reported.
Time frame: Baseline, Day 57
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Erythema | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Erythema | Grade 0 | 81 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Erythema | Grade 1 | 19 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Erythema | Grade 2 | 5 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Erythema | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Erythema | Grade 0 | 95 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Erythema | Grade 1 | 7 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Erythema | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Flaking/Scaling | Grade 0 | 84 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Flaking/Scaling | Grade 1 | 17 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Flaking/Scaling | Grade 2 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Flaking/Scaling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Flaking/Scaling | Grade 0 | 99 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Flaking/Scaling | Grade 1 | 3 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Flaking/Scaling | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Flaking/Scaling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Crusting | Grade 0 | 103 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Crusting | Grade 1 | 2 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Crusting | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Crusting | Grade 0 | 102 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Crusting | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Crusting | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Swelling | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Swelling | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Swelling | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Swelling | Grade 0 | 102 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Swelling | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Swelling | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Vesiculation/Pustulation | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Vesiculation/Pustulation | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Vesiculation/Pustulation | Grade 0 | 102 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Vesiculation/Pustulation | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Erosion/Ulceration | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Erosion/Ulceration | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Erosion/Ulceration | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | Baseline: Erosion/Ulceration | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Erosion/Ulceration | Grade 0 | 102 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Erosion/Ulceration | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Erosion/Ulceration | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 | At Day 57: Erosion/Ulceration | Grade 3 | 0 Participants |
Primary
Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8
Local tolerability score was evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. Number of participants categorized by local tolerability score by visit for each individual signs (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) at Day 8 were reported.
Time frame: Baseline, Day 8
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Erythema | Grade 0 | 81 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Erythema | Grade 1 | 19 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Erythema | Grade 2 | 5 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Erythema | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Erythema | Grade 0 | 9 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Erythema | Grade 1 | 32 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Erythema | Grade 2 | 57 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Erythema | Grade 3 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Flaking/Scaling | Grade 0 | 84 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Flaking/Scaling | Grade 1 | 17 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Flaking/Scaling | Grade 2 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Flaking/Scaling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Flaking/Scaling | Grade 0 | 18 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Flaking/Scaling | Grade 1 | 43 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Flaking/Scaling | Grade 2 | 33 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Flaking/Scaling | Grade 3 | 8 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Crusting | Grade 0 | 103 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Crusting | Grade 1 | 2 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Crusting | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Crusting | Grade 0 | 66 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Crusting | Grade 1 | 28 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Crusting | Grade 2 | 8 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Swelling | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Swelling | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Swelling | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Swelling | Grade 0 | 75 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Swelling | Grade 1 | 19 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Swelling | Grade 2 | 8 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Vesiculation/Pustulation | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Vesiculation/Pustulation | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Vesiculation/Pustulation | Grade 0 | 101 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Vesiculation/Pustulation | Grade 1 | 1 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Erosion/Ulceration | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Erosion/Ulceration | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Erosion/Ulceration | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | Baseline: Erosion/Ulceration | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Erosion/Ulceration | Grade 0 | 91 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Erosion/Ulceration | Grade 1 | 8 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Erosion/Ulceration | Grade 2 | 3 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 | At Day 8: Erosion/Ulceration | Grade 3 | 0 Participants |
Primary
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
TEAEs were defined as either those adverse events (AEs) with an onset after dosing or those pre-existing conditions that worsened after dosing. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an Investigational Product. An SAE with any untoward medical occurrence that at any dose, resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect in the child of a participant who was exposed to the study drug, or any other medically important event that may jeopardize the patient or require intervention to prevent one of the other outcomes. AESI's included in this study were skin cancers (including basal cell carcinoma, squamous cell carcinoma, and melanoma) based on their relevance for the current intended use. TEAEs included both serious and non-serious AEs.
Time frame: Baseline up to Day 57
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) | Participants with TEAEs | 29 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) | Participants with Serious TEAEs | 2 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) | Participants with AESIs | 2 Participants |
Primary
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Clinically significant ECGs abnormalities assessment was based on Investigator interpretation. Number of participants with clinically significant abnormalities in ECG were reported.
Time frame: Baseline up to Day 57
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | 1 Participants |
Primary
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Laboratory parameters included blood chemistry, hamatology, and urinalysis. Clinically significant laboratory abnormalities assessment was based on Investigator interpretation. Number of participants with clinically significant abnormalities in laboratory parameters (included hematology, blood chemistry and urinalysis) were reported.
Time frame: Baseline up to Day 57
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | 0 Participants |
Primary
Number of Participants With Clinically Significant Abnormalities in Physical Examination
Physical examination included weight and height measurements. Clinically significant physical examination abnormalities assessment was based on Investigator interpretation. Number of participants with clinically significant abnormalities in physical examination were reported.
Time frame: Baseline up to Day 57
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants With Clinically Significant Abnormalities in Physical Examination | 1 Participants |
Primary
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinically significant vital signs abnormalities assessment was based on Investigator interpretation. Number of participants with clinically significant abnormalities in vital signs were reported.
Time frame: Baseline up to Day 57
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants With Clinically Significant Abnormalities in Vital Signs | 1 Participants |
Primary
Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration)
Maximum local tolerability score post baseline was defined as the highest grade of any LSR reported at any post-baseline visits for a participant. Local tolerability score was assessed for signs erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe symptoms. If a participant maximum individual sign local tolerability score stayed at 0 throughout the study, the participant was considered censored at last local tolerability score observation. Number of participants with maximum local tolerability score for each individual signs including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration were reported.
Time frame: Baseline, Maximum post-baseline (up to Day 57)
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, Number analyzed signifies participants who were evaluated at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Erythema | Grade 0 | 81 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Erythema | Grade 1 | 19 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Erythema | Grade 2 | 5 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Erythema | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Erythema | Grade 0 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Erythema | Grade 1 | 27 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Erythema | Grade 2 | 66 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Erythema | Grade 3 | 6 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Flaking/Scaling | Grade 0 | 84 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Flaking/Scaling | Grade 1 | 17 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Flaking/Scaling | Grade 2 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Flaking/Scaling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Flaking/Scaling | Grade 0 | 16 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Flaking/Scaling | Grade 1 | 34 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Flaking/Scaling | Grade 2 | 44 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Flaking/Scaling | Grade 3 | 9 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Crusting | Grade 0 | 103 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Crusting | Grade 1 | 2 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Crusting | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Crusting | Grade 0 | 58 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Crusting | Grade 1 | 34 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Crusting | Grade 2 | 11 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Crusting | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Swelling | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Swelling | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Swelling | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Swelling | Grade 0 | 64 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Swelling | Grade 1 | 28 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Swelling | Grade 2 | 11 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Swelling | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Vesiculation/Pustulation | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Vesiculation/Pustulation | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Vesiculation/Pustulation | Grade 0 | 99 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Vesiculation/Pustulation | Grade 1 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Vesiculation/Pustulation | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Vesiculation/Pustulation | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Erosion/Ulceration | Grade 0 | 105 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Erosion/Ulceration | Grade 1 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Erosion/Ulceration | Grade 2 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | Baseline: Erosion/Ulceration | Grade 3 | 0 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Erosion/Ulceration | Grade 0 | 90 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Erosion/Ulceration | Grade 1 | 9 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Erosion/Ulceration | Grade 2 | 4 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) | At Maximum post-baseline (up to Day 57): Erosion/Ulceration | Grade 3 | 0 Participants |
Primary
Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15
Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 15 was reported.
Time frame: Baseline, Day 15
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | Baseline: Hypopigmentation Presence | 22 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | Baseline: Hypopigmentation Absence | 83 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | At Day 15: Hypopigmentation Presence | 21 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | At Day 15: Hypopigmentation Absence | 80 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | Baseline: Hyperpigmentation Presence | 28 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | Baseline: Hyperpigmentation Absence | 77 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | At Day 15: Hyperpigmentation Presence | 20 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | At Day 15: Hyperpigmentation Absence | 81 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | Baseline: Scarring Presence | 12 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | Baseline: Scarring Absence | 93 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | At Day 15: Scarring Presence | 11 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 | At Day 15: Scarring Absence | 90 Participants |
Primary
Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29
Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 29 was reported.
Time frame: Baseline, Day 29
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | Baseline: Hypopigmentation Presence | 22 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | Baseline: Hypopigmentation Absence | 83 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | At Day 29: Hypopigmentation Presence | 20 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | At Day 29: Hypopigmentation Absence | 80 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | Baseline: Hyperpigmentation Presence | 28 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | Baseline: Hyperpigmentation Absence | 77 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | At Day 29: Hyperpigmentation Presence | 16 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | At Day 29: Hyperpigmentation Absence | 84 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | Baseline: Scarring Presence | 12 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | Baseline: Scarring Absence | 93 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | At Day 29: Scarring Presence | 10 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 | At Day 29: Scarring Absence | 90 Participants |
Primary
Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5
Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 5 was reported.
Time frame: Baseline, Day 5
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | Baseline: Hypopigmentation Presence | 22 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | Baseline: Hypopigmentation Absence | 83 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | At Day 5: Hypopigmentation Presence | 22 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | At Day 5: Hypopigmentation Absence | 78 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | Baseline: Hyperpigmentation Presence | 28 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | Baseline: Hyperpigmentation Absence | 77 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | At Day 5: Hyperpigmentation Presence | 26 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | At Day 5: Hyperpigmentation Absence | 74 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | Baseline: Scarring Presence | 12 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | Baseline: Scarring Absence | 93 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | At Day 5: Scarring Presence | 12 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 | At Day 5: Scarring Absence | 88 Participants |
Primary
Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57
Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 57 was reported.
Time frame: Baseline, Day 57
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | At Day 57: Scarring Absence | 93 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | Baseline: Hypopigmentation Presence | 22 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | Baseline: Hypopigmentation Absence | 83 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | At Day 57: Hypopigmentation Presence | 18 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | At Day 57: Hypopigmentation Absence | 84 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | Baseline: Hyperpigmentation Presence | 28 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | Baseline: Hyperpigmentation Absence | 77 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | At Day 57: Hyperpigmentation Presence | 16 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | At Day 57: Hyperpigmentation Absence | 86 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | Baseline: Scarring Presence | 12 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | Baseline: Scarring Absence | 93 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 | At Day 57: Scarring Presence | 9 Participants |
Primary
Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8
Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 8 was reported.
Time frame: Baseline, Day 8
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | Baseline: Hypopigmentation Presence | 22 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | Baseline: Hypopigmentation Absence | 83 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | At Day 8: Hypopigmentation Presence | 21 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | At Day 8: Hypopigmentation Absence | 80 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | Baseline: Hyperpigmentation Presence | 28 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | Baseline: Hyperpigmentation Absence | 77 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | At Day 8: Hyperpigmentation Presence | 23 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | At Day 8: Hyperpigmentation Absence | 78 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | Baseline: Scarring Presence | 12 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | Baseline: Scarring Absence | 93 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | At Day 8: Scarring Presence | 13 Participants |
| Tirbanibulin (Klisyri®) | Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 | At Day 8: Scarring Absence | 88 Participants |
Primary
Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration
Time to maximum local tolerability score (in days) for each individual sign was calculated as \[Date of first post-baseline occurrence of maximum local tolerability score for this individual sign - Date of first dose\]. If a participant maximum individual sign LTA score stays at 0 throughout the study, the participants was considered censored at their last LTA score observation. Maximum local tolerability score was assessed for each signs using a 4 - point scale of 0 - 3, where 0 = absent, 1= mild, 2= moderate and 3 = severe. The higher score indicates severe symptoms. Time to maximum local tolerability score for erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration was reported.
Time frame: Baseline up to Day 57
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tirbanibulin (Klisyri®) | Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration | Erythema | 4.0 Days |
| Tirbanibulin (Klisyri®) | Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration | Flaking/Scaling | 7.0 Days |
| Tirbanibulin (Klisyri®) | Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration | Crusting | 7.0 Days |
| Tirbanibulin (Klisyri®) | Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration | Swelling | 4.0 Days |
| Tirbanibulin (Klisyri®) | Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration | Vesiculation/Pustulation | 4.0 Days |
| Tirbanibulin (Klisyri®) | Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration | Erosion/Ulceration | 7.0 Days |
Primary
Time to Maximum Local Tolerability Total Composite Score
Time to maximum composite local tolerability score (in days) was calculated as (Date of first post-baseline occurrence of maximum composite local tolerability score - Date of first dose). The maximum local tolerability signs composite score across visits was derived as the maximum local tolerability composite score observed post-baseline. Local tolerability signs composite score was defined as the sum of the scores graded from 0 (absent) to 3 (severe) on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration which gave total composite score ranged from 0 to 18. The higher score indicates severe symptoms. If a participant's maximum composite local tolerability score stays at 0 throughout the study, the participant was considered censored at their last local tolerability score observation. Time to maximum local tolerability total composite score was reported.
Time frame: Baseline up to Day 57
Population: The safety population included all enrolled participants who received at least 1 dose of the study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tirbanibulin (Klisyri®) | Time to Maximum Local Tolerability Total Composite Score | 7.0 Days |