Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

All Drugs and Chemicals

Tirbanibulin

Enzyme Inhibitors

Participants will apply tirbanibulin ointment- topically at a dose of 2.5 mg once daily for 5 consecutive days- on the face or scalp.

Participants will apply tirbanibulin 2.5 mg ointment topically for 5 consecutive days over 25 square centimeters (cm\^2) of the face or scalp.

Tirbanibulin 2.5 mg ointment

Alberto Lecchi

The purpose of the study is to assess treatment satisfaction on Day 57 in participants with Actinic Keratoses (AK) of the face or scalp following treatment with tirbanibulin ointment 1 percent (%) administered once daily for 5 consecutive days.

A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses

Open Phase IV Study to Assess the Impact of Tirbanibulin on the Wellbeing of Patients With Actinic Keratoses (TIRBASKIN)

TSQM-9 is a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. In this self-administered questionnaire the 5 items associated with side effects related to the medication were excluded. The TSQM-9 global total scores vary from 0 to 100 with higher score indicating higher treatment satisfaction.

Skindex-16 is used for participants to rate skin conditions that have occurred within the previous week. It is a short 16-item patient-completed assessment that are classified into three domains: symptoms \[four items, 1-4\], emotions, \[seven items, 5-11\] and functioning \[five items, 12-16\]. All items are scored on a seven-point numerical analogue scales (0=never bothered to 6=always bothered). The potential global score is the average of all 16 items ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 (never bothered) to 100 (always bothered). The higher the score, the more severe is the impairment.

Likert scale is an instrument used to measure the individual's degree of agreement and disagreement with a variety of statements about some attitude, options, or their feelings. In this study, the product's organoleptic properties are evaluated with Likert scale. The questionnaire is built with questions related to the product's characteristics namely appearance, color, convenience, texture, smell, and the feelings experienced during drug application. The Likert scale offers 7 possible answers, from "totally agree" to "totally in disagreement."

TSQM 1.4 is a 14-item robust instrument that psychometrically evaluates the treatment satisfaction of the administered medication. The instrument is designed with 4 scales consisting of 14 questions. These 14 questions were derived from an original set of 55 questions extracted from exhaustive literature review and treatment groups through multistep iterative process. The 4 scales focused on efficacy (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14). The global total score ranges from 0 - 100, where lower scores imply less satisfaction whilst higher scores imply higher satisfaction.

The lesions in the identified treatment area will be classified based on Olsen characterization. Classification of AK lesions according to Olsen grade of baseline lesions: Olsen Grade I: Early AK appear as single or few, differently sized, rough, blurred, less visible than palpable, red, rough spots or very flat, non-edged plaques which reach into the reddish color; Olsen grade II describes advanced AK as clearly visible and palpable, flat, and irregularly raised, with sharp or blurred boundaries, red, rough keratinized surface. If the surface is more strongly keratinized, the AK can also be white, yellow, or light brown. After scratching effects, a black or blue-black shade may appear; Olsen grade III denotes "late" AK that have existed for a longer period of time and are firmly anchored on the lower surface, with an irregular, humpy surface, also wart-like and of different colors (white, brown, black).

RCM is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. RCM can visualize cells with a resolution comparable to a light microscope, allowing the investigators to identify the degree of inflammation and damage to the skin. An overall disease severity score ranging from 0-3 (0=none, 1=mild, 2= moderate, 3=severe) will use aggregates of the following features: Spongiosis, Parakeratosis, Epidermal thickness, Quality of honeycomb structure of the stratum spinosum, Appearance of the dermal-epidermal junction, Appearance of the superficial dermis, Recognition of the dermal papilla, Caliber of blood vessels, Presence of inflammatory cells, Grading will be scored (0=none, 1=mild, 2= moderate, 3=severe), a greater numerical score indicates more advanced disease.

OCT is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. OCT can detect deep structures in the skin, identify areas of inflammation, and determine the thickness of the skin. These measures will be consolidated to a severity score ranging 0-3, (0= no disease, 3= severe disease) and will be tracked throughout the duration of the study. The following features will be aggregated to form an Optical Coherence Tomography-severity-score: Change in the epidermal thickness; Changes in anatomy or appearance of the dermo-epidermal junction and the dermis; Changes in vascular flow patterns, including the number and density of vessels in skin using the dynamic feature of Optical Coherence Tomography; Grading will be scored 0=none, 1=mild, 2= moderate, 3=severe.

Almirall, S.A.

Symptoms and General Pathology

Facies

Klisyri® 10 mg/g Ointment (Tirbanibulin) patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC.

Interventional, monocentric, national, single-arm, uncontrolled, open, prospective phase IV study. Since this study is not powered for confirmative testing, analysis is done by descriptive statistics Eligible AK patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC. Diagnosis and monitoring of treatment effects are supported by UV imaging using Canfield VISIA®. Safety and efficacy are assessed at end of treatment visit (EoT, approximately 3 days after the last dose, i.e, day 8 ± 2) and at a follow-up visit (FuV) 57 ± 7 d after the start of the treatment. UV images (Canfield VISIA®) will be taken at baseline, EoT and FuV, accompanied by conventional dermatological assessment according to clinical routine.

Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

Total clearance rates of unmasked lesions 57± 7 days after the start of the treatment.

Medical University of Graz

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Subjects will be given one study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days. Subjects with unresolved lesion at d28 or d56 or d72 or d84 will be given an additional study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days.

Philippe Bahadoran, PhD

Henri Montaudie, PhD

Philippe Bahadoran

philippe Bahadoran, PhD

his is a Phase 2, Single-Arm, Open-Label, Single Center, to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects with superficial basal cell carcinoma (sBCC) not arising on the face or scalp

This is a pilot study aimed at studying the efficacy and tolerance of a new topical treatment regimen in BCC. The number of 50 sBCC to be treated was established based on previous studies that have investigated the effectiveness of a topical regimen in sBCC. Considering that approximately 10% of BCCs will be wrongly included or not evaluable or will present with a deviation protocol major, a total of 55 sBCC will be included in the study.Inclusion Criteria :

* Age \> 18 years
* Histologically confirmed, primary, previously untreated, superficial basal cell carcinoma (sBCC) not arising on the face or scalp, ≤ 15 mm (large axis)

Exclusion Criteria :

* BCC of the face or scalp
* BCC of non-superficial subtype
* BCC with large axis \> 15mm
* Relapsing BCC
* Allergy to treatment
* Treatment with cryotherapy, imiquimod, PDT, or radiotherapy in the BCC area during the 6 months prior to the screening visit. Visits : 1) Selection visit = V0: if the patient meets the selection criteria, oral and written information will be given to him. If the patient signs the consent during this consultation, the inclusion visit will be carried out at the same time. 2) Inclusion visit and start of treatment = V1 (D1): for patients who have not signed their consent at the previous visit, consent will be collected • Verification of inclusion and non-inclusion criteria • Collection of medical and surgical history • Collection of previous and concomitant treatments • Clinical evaluation by visual inspection: measurement of the long axis, calculation of the surface to be treated (maximum treated surface for all sBCC should not exceed \> 25 cm2) • Realization of a layer with the limits of the lesion • Clinical photos • Examination by LC-OCT • Dispensing of Tirbanibulin for the treatment cycle (1 tube for up to 3 sBCC) • Explanation of the mode of application to the patient • First application performed on site • Giving the patient a notebook to record the applications of the product and local skin reactions. 3) Follow-up visit +/- retreatment = V2 (D28 ± 2 d) • Collection of adverse events and changes in concomitant treatments • Collection of local skin reactions in the patient notebook • Evaluation of local skin reactions • Clinical evaluation and by LC-OCT -\> In case of cure clinically and by LC-OCT (complete remission, CR) end of the study for the patient -\> In the absence of CR processing as in V1 -\> in case of a wound at the application site, the study will end for the patient and he will be treated according to standard recommendantions for• sBCC 4) Additional follow-up visits +/- retreatment = V3 (D56±2 days), V4 (D84+/-2d) : these visits will be conducted identically to V2. 5) Short-term efficacy visit = V5 (D112 +/- 2d): same as V2 w/o treatment with Tirbanibulin. Patients not in CR will terminate the study and will be treated according to standard recommendations for sBCC. 6) Long-term efficacy visit = V6 (M12): same as V2 w/o treatment with Tirbanibulin. All patients will terminate the study. Patients with relapse of their BCC will be treated according to standard recommendations for sBCC.

Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma

Open, Prospective Study Evaluating the Efficacy and Safety of 0.05% Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma

Type, frequency, severity and time to onset of adverse effects. Adverse effects will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale. Local adverse effects will be assessed by the LSR score.

Complete remission after the 1st, 2nd, 3rd or 4th cycle of Tirbanibulin (Klisiry®) in sBCC.

Centre Hospitalier Universitaire de Nice

subjects receive 2,5 mgTirbanibulin in 250 mg ointment with daily administration of one single sachet on the left hand and 250mg ointment placebo on the right hand for 5 d in a single-blinded manner.

Interventional, monocentric, national, internal placebo-controlled, prospective pilot study, consisting of two parts, A (single-blinded) and B (open) to assess Efficacy of Tirbanibulin for the treatment of AK on the back of the hand. In part A, eligible subjects receive Tirbanibulin on the left hand and placebo on the right hand for 5 d in a single-blinded manner. Safety and efficacy are assessed at day 8 (± 1 d) (3 days after the end of treatment (EoT+3) and day 57 (± 7 d) after the start of the treatment. Pictures will be taken at baseline, 8 d and 57 d (± 7 d) as per protocol and optional during unscheduled visits.

Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands

Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands. An Internally Placebo Controlled, Partly Blinded Clinical Pilot Study

Almirall, SAS

Participants will apply tirbanibulin 10 mg/g ointment once daily for 5 consecutive days beginning on Day 1. All participants will be evaluated for efficacy, safety, and tolerability at Day 8, 15, 29, and 57. Participants who do not achieve complete clearance (CC) at Day 57 will receive a second 5-day course of the treatment. Participants receiving a second treatment course will also be evaluated for efficacy, safety, and tolerability at Day 64, 71, and 85.

Participants will apply vehicle ointment once daily for 5 consecutive days beginning on Day 1. All participants will be evaluated for efficacy, safety, and tolerability at Day 8, 15, 29, and 57. Participants who do not achieve CC at Day 57 will receive a second 5-day course of the treatment. Participants receiving a second treatment course will also be evaluated for efficacy, safety, and tolerability at Day 64, 71, and 85.

Participants will apply tirbanibulin ointment topically on the face or balding scalp with AK.

Participants will apply vehicle ointment topically on the face or balding scalp with AK.

Vehicle ointment

Davide Carluccio

Ana Lucía Matamoros Díaz

The purpose of the study is to evaluate the efficacy and safety of tirbanibulin 10 milligrams per gram (mg/g) ointment when applied to a treatment field (TF) larger than 25 centimeter square (cm\^2) and up to 100 cm\^2 in adult participants with actinic keratosis (AK).

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

A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm^2 and up to 100 cm^2 in Adult Patients With Actinic Keratosis

Percentage change from baseline in the AK lesion count will be assessed.

PC is defined as proportion of participants achieving more than or equal to (\>=) 75 percent (%) clearance of AK lesions in the TF on the face or scalp at Day 57.

CC is defined as proportion of participants achieving 100 percent clearance of AK lesions in the TF on the face or scalp at Day 57.

Number of new lesions that are not present at baseline, occurring per participant in the TF at specific timepoints will be assessed.

Number of lesions per participant in the TF at specific timepoints will be assessed.

Skindex-16 is used for participants to rate skin conditions that have occurred within the previous week. It is a short 16-item patient-completed assessment that are classified into three domains: symptoms \[four items, 1-4\], emotions, \[seven items, 5-11\] and functioning \[five items, 12-16\]. All items are scored on a seven-point numerical analogue scales (0=never bothered to 6=always bothered). Each item is then transformed to a linear scale from 0 (never bothered) to 100 (always bothered), where higher the score = more severe in impairment. The total score is the average of all 16 items scores ranging from 0 \[best Health Related Quality of Life (HRQoL)\] to 96 (worst HRQoL), where higher score indicates worst quality of life.

Cosmetic Outcome is rated on a 4-point scale as excellent (no or mild redness or change in pigmentation), good (moderate redness or change in pigmentation), fair (slight-to-moderate scarring, atrophy, or induration), and poor (extensive scarring, atrophy, or induration).

The TSQM-14 is a participant-rated scale used to assess subjective satisfaction with medication. The TSQM-14 provided scores on 4 domains: effectiveness (questions 1 to 3) side effects (4 to 8), convenience (9 to 11), and global satisfaction (12 to 14). With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). Scores for each domain were transformed into a final score ranging from 0 to 100, with higher numbers indicating a higher level of satisfaction.

Local tolerability score is evaluated by the 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 is applied. These symptoms are assessed by using a 4-point scale of 0-3, where 0 (absent) and 3 (severe). The higher score indicates severe symptoms.

Maximum local tolerability score by treatment course for each individual sign (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. Local tolerability score for each signs are assessed by using a 4 - point scale of 0 - 3, where 0 = none 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 will be assessed. Maximum local tolerability score by treatment course for each individual sign (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. Local tolerability score for each signs are assessed by using a 4 - point scale of 0 - 3, where 0 = none and 3 = severe. The higher score indicates severe symptoms.

Local tolerability signs composite score (0-18) at Specific Timepoints, defined as the sum of the scores graded from 0 (none) to 3 (severe) on all six individual tolerability sign categories (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. The higher score indicates severe symptoms.

Maximum local tolerability signs composite score (0-18) in treatment course, defined as the sum of the scores graded from 0 (none) to 3 (severe) on all six individual tolerability sign categories (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. The higher score indicates severe symptoms.

Time to maximum local tolerability signs composite score is observed in treatment course for each individual sign (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. Maximum local tolerability signs composite score (0-18) in treatment course, defined as the sum of the scores graded from 0 (none) to 3 (severe) on all six individual tolerability sign categories (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. The higher score indicates severe symptoms.

Absence or presence of pigmentation (that is, hypopigmentation and hyperpigmentation) and scarring in the TF will be assessed.

An AE is defined as any untoward medical occurrence in a clinical trial participant, regardless of the administration of the IMP and its causal relationship to it. unfavorable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, or an abnormal finding in the physical examination. An SAE is any untoward medical occurrence that at any dose resulted in death; is life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in participant hospitalization; is congenital anomaly/birth defect or otherwise considered medically important. AESIs included skin cancers \[including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma\] appearing within or outside the TF during the study.

Number of participants with clinically significant laboratory abnormalities (included hematology, blood chemistry and urinalysis) will be assessed. Clinically Significant Abnormal values will be determined by the investigator.

Number of participants with vital signs (including measurement of systolic and diastolic blood pressure, heart rate, respiratory rate, and tympanic temperature) will be assessed. Abnormal values will be determined by the investigator.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses	NCT05741294	Actinic Keratos...	Tirbanibulin 2....	18 Years -	Almirall, S.A.
Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face	NCT05900258	Actinic Keratos...	Tirbanibulin	-	Medical University of Graz
Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma	NCT06112522	Cell Carcinoma	Tirbanibulin	18 Years -	Centre Hospitalier Universitaire de Nice
A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses	NCT05741294	Actinic Keratos...	Tirbanibulin 2....	18 Years -	Almirall, S.A.
Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands	NCT06026358	Actinic Keratos...	Tirbanibulin	18 Years - 99 Years	Medical University of Graz
A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis	NCT06135415	Keratosis, Acti...	Tirbanibulin Vehicle ointmen...	18 Years -	Almirall, S.A.
Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma	NCT06112522	Cell Carcinoma	Tirbanibulin	18 Years -	Centre Hospitalier Universitaire de Nice
Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma	NCT06112522	Cell Carcinoma	Tirbanibulin	18 Years -	Centre Hospitalier Universitaire de Nice

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