Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Facies

Keratosis, Actinic

Keratosis

Alopecia

Alopecia Areata

Skin Diseases

Precancerous Conditions

Chiari Malformation Type 2

All Drugs and Chemicals

Tirbanibulin

Enzyme Inhibitors

Participants will apply tirbanibulin ointment 1% once daily for 5 days beginning Day 1. Participants will be evaluated for safety, tolerability, and the presence of Actinic Keratosis (AK) lesions in the treatment field (TF) until completion of the response assessment period at Day 57.

Applied topically for 5 days over a field of approximately 100 cm\^2 on the face or balding scalp with AK.

Tirbanibulin ointment 1%

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.

A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis

A Phase 3, Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% Applied to a Field of Approximately 100 cm2 on the Face or Balding Scalp in Adult Patients With Actinic Keratosis

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.

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.

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.

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.

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.

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 (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 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 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 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 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 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.

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 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.

Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 5 was reported.

Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 8 was reported.

Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 15 was reported.

Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 29 was reported.

Absence and presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment field by visit at Day 57 was reported.

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.

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.

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.

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.

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.

Almirall, S.A.

The safety population included all enrolled participants who received at least 1 dose of the study drug.

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.

Tirbanibulin (Klisyri®)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Number of AK lesions at baseline

Head of Global Clinical Development

Baseline: Erythema

At Day 5: Erythema

Baseline: Flaking/Scaling

At Day 5: Flaking/Scaling

Baseline: Crusting

At Day 5: Crusting

Baseline: Swelling

At Day 5: Swelling

Baseline: Vesiculation/Pustulation

At Day 5: Vesiculation/Pustulation

Baseline: Erosion/Ulceration

At Day 5: Erosion/Ulceration

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.

Number of 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 8: Erythema

At Day 8: Flaking/Scaling

At Day 8: Crusting

At Day 8: Swelling

At Day 8: Vesiculation/Pustulation

At Day 8: Erosion/Ulceration

Number of 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 15: Erythema

At Day 15: Flaking/Scaling

At Day 15: Crusting

At Day 15: Swelling

At Day 15: Vesiculation/Pustulation

At Day 15: Erosion/Ulceration

Number of 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 29: Erythema

At Day 29: Flaking/Scaling

At Day 29: Crusting

At Day 29: Swelling

At Day 29: Vesiculation/Pustulation

At Day 29: Erosion/Ulceration

Number of 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 57: Erythema

At Day 57: Flaking/Scaling

At Day 57: Crusting

At Day 57: Swelling

At Day 57: Vesiculation/Pustulation

At Day 57: Erosion/Ulceration

Number of 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 Maximum post-baseline (up to Day 57): Erythema

At Maximum post-baseline (up to Day 57): Flaking/Scaling

At Maximum post-baseline (up to Day 57): Crusting

At Maximum post-baseline (up to Day 57): Swelling

At Maximum post-baseline (up to Day 57): Vesiculation/Pustulation

At Maximum post-baseline (up to Day 57): Erosion/Ulceration

Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration)

Erythema

Flaking/Scaling

Crusting

Swelling

Vesiculation/Pustulation

Erosion/Ulceration

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.

Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration

Baseline

At Day 5

Local Tolerability Signs Total Composite Score by Visit at Day 5

At Day 8

Local Tolerability Signs Total Composite Score by Visit at Day 8

At Day 15

Local Tolerability Signs Total Composite Score by Visit at Day 15

At Day 29

Local Tolerability Signs Total Composite Score by Visit at Day 29

At Day 57

Local Tolerability Signs Total Composite Score by Visit at Day 57

At Maximum post-baseline (up to Day 57)

Maximum Local Tolerability Signs Total Composite Score Post Baseline

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.

Time to Maximum Local Tolerability Total Composite Score

Baseline: Hypopigmentation Presence

Baseline: Hypopigmentation Absence

At Day 5: Hypopigmentation Presence

At Day 5: Hypopigmentation Absence

Baseline: Hyperpigmentation Presence

Baseline: Hyperpigmentation Absence

At Day 5: Hyperpigmentation Presence

At Day 5: Hyperpigmentation Absence

Baseline: Scarring Presence

Baseline: Scarring Absence

At Day 5: Scarring Presence

At Day 5: Scarring Absence

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.

Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5

At Day 8: Hypopigmentation Presence

At Day 8: Hypopigmentation Absence

At Day 8: Hyperpigmentation Presence

At Day 8: Hyperpigmentation Absence

At Day 8: Scarring Presence

At Day 8: Scarring Absence

Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8

At Day 15: Hypopigmentation Presence

At Day 15: Hypopigmentation Absence

At Day 15: Hyperpigmentation Presence

At Day 15: Hyperpigmentation Absence

At Day 15: Scarring Presence

At Day 15: Scarring Absence

Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15

At Day 29: Hypopigmentation Presence

At Day 29: Hypopigmentation Absence

At Day 29: Hyperpigmentation Presence

At Day 29: Hyperpigmentation Absence

At Day 29: Scarring Presence

At Day 29: Scarring Absence

Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29

At Day 57: Hypopigmentation Presence

At Day 57: Hypopigmentation Absence

At Day 57: Hyperpigmentation Presence

At Day 57: Hyperpigmentation Absence

At Day 57: Scarring Presence

At Day 57: Scarring Absence

Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57

Participants with TEAEs

Participants with Serious TEAEs

Participants with AESIs

Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)

Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

Number of Participants With Clinically Significant Abnormalities in Vital Signs

Number of Participants With Clinically Significant Abnormalities in Physical Examination

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)

Participants applied tirbanibulin ointment 1% topically once daily on Day 1 for 5 days over a field of approximately 100 square centimeters (cm\^2) on the face or balding scalp with Actinic Keratosis (AK).

Overall Study

Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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