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

Primary Purpose

Actinic Keratosis

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tirbanibulin 2.5 mg ointment
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Keratosis, Tirbanibulin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent. Males or females aged greater than or equal to (>=)18 years. Diagnosis of clinically typical AK in one contiguous area on the face or scalp with a treatment area of 25^cm2 containing 4-8 AK lesions. Participants not previously treated for AK on the current treatment area of the face or scalp in the last 6 months. However, previous AK treatment in other small areas (up to 25^cm2) in the last greater than >1 to less than <6 months is allowed. Females must be postmenopausal (A female said to be postmenopausal should be >45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of child-bearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive intercourse. Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment. All participants must agree not to donate sperm or eggs from screening through 90 days following their last dose of study treatment. Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0 prior to dose administration. Willing to avoid excessive sun or UV (ultraviolet light) light exposure to the face or scalp. Exclusion Criteria: Clinically atypical and/or rapidly changing AK lesions. Location of the treatment area is within 5 cm of an incompletely healed wound or a suspected basal cell carcinoma (BCC)/squamous cell carcinoma (SCC). Skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., open wounds, scarring) in the treatment area that might interfere with the study results or suppose an unacceptable risk. History of sensitivity to any of the ingredients in the tirbanibulin formulation. Participated in a clinical trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing. Participants with a history of tirbanibulin treatment for AK lesions and participants who are currently on tirbanibulin treatment for AK lesions. Use of immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/ interferon inducers and systemic immunosuppressive agents (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab) within 4 weeks prior to the Screening visit, except for organ transplant recipients under stable immunosuppressive therapy for 6 months. Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit. Use of the following therapies and/or medications within 2 weeks prior to the Screening Visit: Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area Topical salves (nonmedicated/nonirritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area. Females who are pregnant or nursing.

Sites / Locations

  • Almirall Investigational Site 3Recruiting
  • Almirall Investigational Site 1Recruiting
  • Almirall Investigational Site 2Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tirbanibulin 2.5 milligrams (mg) ointment

Arm Description

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

Outcomes

Primary Outcome Measures

Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score at Day 57
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.

Secondary Outcome Measures

Change from Baseline in Skindex-16 at Day 57
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.
Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8
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."
Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Total Score at Day 57
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.
Participant Treatment Preference Assessed Through Question 1 to Question 9 of the Expert Panel Questionnaire (EPQ) at Day 57
Percentage of Participants with Complete (100%) Clearance of all Lesions Within the Application Area at Day 57
Percentage of Participants with Partial Clearance, defined as a (Reduction of at least 75%) of Lesions Within the Application Area at Day 57
The lesions in the identified treatment area will be classified based on Olsen characterization. Classification of AK lesions according to Olsen grade of baseline lesions: Olsen Grade I: Early AK appear as single or few, differently sized, rough, blurred, less visible than palpable, red, rough spots or very flat, non-edged plaques which reach into the reddish color; Olsen grade II describes advanced AK as clearly visible and palpable, flat, and irregularly raised, with sharp or blurred boundaries, red, rough keratinized surface. If the surface is more strongly keratinized, the AK can also be white, yellow, or light brown. After scratching effects, a black or blue-black shade may appear; Olsen grade III denotes "late" AK that have existed for a longer period of time and are firmly anchored on the lower surface, with an irregular, humpy surface, also wart-like and of different colors (white, brown, black).
Median Number of Old and New AK Lesions at Day 57
Number of Lesions Classified Based on Olsen Characterization
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).
Noninvasive Imaging (Subclinical Lesions Response) with Reflectance Confocal Microscopy (RCM)
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.
Noninvasive Imaging (Subclinical Lesions Response) with Optical Coherence Tomography (OCT)
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.
Physician Outcomes Assessed Through Question 1 to Question 10 of the EPQ
Number of Participants with Adverse Events and Severity of Adverse Events

Full Information

First Posted
February 14, 2023
Last Updated
August 1, 2023
Sponsor
Almirall, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05741294
Brief Title
A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses
Official Title
Open Phase IV Study to Assess the Impact of Tirbanibulin on the Wellbeing of Patients With Actinic Keratoses (TIRBASKIN)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Keratosis, Tirbanibulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tirbanibulin 2.5 milligrams (mg) ointment
Arm Type
Experimental
Arm Description
Participants will apply tirbanibulin ointment- topically at a dose of 2.5 mg once daily for 5 consecutive days- on the face or scalp.
Intervention Type
Drug
Intervention Name(s)
Tirbanibulin 2.5 mg ointment
Intervention Description
Participants will apply tirbanibulin 2.5 mg ointment topically for 5 consecutive days over 25 square centimeters (cm^2) of the face or scalp.
Primary Outcome Measure Information:
Title
Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score at Day 57
Description
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.
Time Frame
At Day 57
Secondary Outcome Measure Information:
Title
Change from Baseline in Skindex-16 at Day 57
Description
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.
Time Frame
Baseline, Day 57
Title
Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8
Description
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."
Time Frame
At Day 8
Title
Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Total Score at Day 57
Description
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.
Time Frame
At Day 57
Title
Participant Treatment Preference Assessed Through Question 1 to Question 9 of the Expert Panel Questionnaire (EPQ) at Day 57
Time Frame
At Day 57
Title
Percentage of Participants with Complete (100%) Clearance of all Lesions Within the Application Area at Day 57
Time Frame
At Day 57
Title
Percentage of Participants with Partial Clearance, defined as a (Reduction of at least 75%) of Lesions Within the Application Area at Day 57
Description
The lesions in the identified treatment area will be classified based on Olsen characterization. Classification of AK lesions according to Olsen grade of baseline lesions: Olsen Grade I: Early AK appear as single or few, differently sized, rough, blurred, less visible than palpable, red, rough spots or very flat, non-edged plaques which reach into the reddish color; Olsen grade II describes advanced AK as clearly visible and palpable, flat, and irregularly raised, with sharp or blurred boundaries, red, rough keratinized surface. If the surface is more strongly keratinized, the AK can also be white, yellow, or light brown. After scratching effects, a black or blue-black shade may appear; Olsen grade III denotes "late" AK that have existed for a longer period of time and are firmly anchored on the lower surface, with an irregular, humpy surface, also wart-like and of different colors (white, brown, black).
Time Frame
At Day 57
Title
Median Number of Old and New AK Lesions at Day 57
Time Frame
At Day 57
Title
Number of Lesions Classified Based on Olsen Characterization
Description
The lesions in the identified treatment area will be classified based on Olsen characterization. Classification of AK lesions according to Olsen grade of baseline lesions: Olsen Grade I: Early AK appear as single or few, differently sized, rough, blurred, less visible than palpable, red, rough spots or very flat, non-edged plaques which reach into the reddish color; Olsen grade II describes advanced AK as clearly visible and palpable, flat, and irregularly raised, with sharp or blurred boundaries, red, rough keratinized surface. If the surface is more strongly keratinized, the AK can also be white, yellow, or light brown. After scratching effects, a black or blue-black shade may appear; Olsen grade III denotes "late" AK that have existed for a longer period of time and are firmly anchored on the lower surface, with an irregular, humpy surface, also wart-like and of different colors (white, brown, black).
Time Frame
Baseline (Day 0) and Day 57
Title
Noninvasive Imaging (Subclinical Lesions Response) with Reflectance Confocal Microscopy (RCM)
Description
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.
Time Frame
Baseline (Day 0), Day 8, Day 15, Day 29, and Day 57
Title
Noninvasive Imaging (Subclinical Lesions Response) with Optical Coherence Tomography (OCT)
Description
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.
Time Frame
Baseline (Day 0), Day 8, Day 15, Day 29, and Day 57
Title
Physician Outcomes Assessed Through Question 1 to Question 10 of the EPQ
Time Frame
At Day 57
Title
Number of Participants with Adverse Events and Severity of Adverse Events
Time Frame
From start of study administration up to Day 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent. Males or females aged greater than or equal to (>=)18 years. Diagnosis of clinically typical AK in one contiguous area on the face or scalp with a treatment area of 25^cm2 containing 4-8 AK lesions. Participants not previously treated for AK on the current treatment area of the face or scalp in the last 6 months. However, previous AK treatment in other small areas (up to 25^cm2) in the last greater than >1 to less than <6 months is allowed. Females must be postmenopausal (A female said to be postmenopausal should be >45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of child-bearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive intercourse. Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment. All participants must agree not to donate sperm or eggs from screening through 90 days following their last dose of study treatment. Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0 prior to dose administration. Willing to avoid excessive sun or UV (ultraviolet light) light exposure to the face or scalp. Exclusion Criteria: Clinically atypical and/or rapidly changing AK lesions. Location of the treatment area is within 5 cm of an incompletely healed wound or a suspected basal cell carcinoma (BCC)/squamous cell carcinoma (SCC). Skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., open wounds, scarring) in the treatment area that might interfere with the study results or suppose an unacceptable risk. History of sensitivity to any of the ingredients in the tirbanibulin formulation. Participated in a clinical trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing. Participants with a history of tirbanibulin treatment for AK lesions and participants who are currently on tirbanibulin treatment for AK lesions. Use of immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/ interferon inducers and systemic immunosuppressive agents (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab) within 4 weeks prior to the Screening visit, except for organ transplant recipients under stable immunosuppressive therapy for 6 months. Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit. Use of the following therapies and/or medications within 2 weeks prior to the Screening Visit: Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area Topical salves (nonmedicated/nonirritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area. Females who are pregnant or nursing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Cappello
Phone
+34 9329130000
Email
valentina.cappello@almirall.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Lecchi
Organizational Affiliation
Almirall, SAS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Almirall Investigational Site 3
City
Rimini
Country
Italy
Individual Site Status
Recruiting
Facility Name
Almirall Investigational Site 1
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Name
Almirall Investigational Site 2
City
Zaragoza
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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