Clinical Trial Results:
Open Phase IV Study to Assess the Impact of Tirbanibulin on the Wellbeing of Patients With Actinic Keratoses (TIRBASKIN)
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Summary
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EudraCT number |
2022-001251-16 |
Trial protocol |
IT ES |
Global end of trial date |
19 Jan 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jan 2025
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First version publication date |
29 Jan 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
M-14789-42
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05741294 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Almirall S.A.
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Sponsor organisation address |
Ronda General Mitre, 151, Barcelona, Spain, 08022
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Public contact |
Valentina Cappello, Almirall, S.A., +34 9329130000, valentina.cappello@almirall.com
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Scientific contact |
Valentina Cappello, Almirall, S.A., +34 9329130000, valentina.cappello@almirall.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Jan 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Jan 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of this study was to assess treatment satisfaction on Day 57 in subjects with AK of the face or scalp following treatment with tirbanibulin ointment 1 percent (%) administered once daily for 5 consecutive days.
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Protection of trial subjects |
This trial was conducted in accordance with the recommendations guiding physicians in biomedical research involving human patients adopted by the 18th World Medical Assembly of Helsinki (1964), as amended in Fortaleza, Brazil (2013), as well as in compliance with ICH GCP E6 (R2) guidelines, and local laws of the Countries in which the trial centres were located.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Jan 2023
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 72
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Country: Number of subjects enrolled |
Spain: 262
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Worldwide total number of subjects |
334
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EEA total number of subjects |
334
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
38
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From 65 to 84 years |
264
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85 years and over |
32
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Recruitment
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Recruitment details |
This study was conducted at 37 sites in Europe (7 in Italy and 30 in Spain) from 20 January 2023 to 19 January 2024. | ||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 340 subjects were screened, of which 334 subjects enrolled in this study. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Subjects (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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Tirbanibulin 2.5 mg | ||||||||||||||||||||
Arm description |
Subjects applied tirbanibulin ointment- topically at a dose of 2.5 milligrams (mg) once daily for 5 consecutive days on the face or scalp. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Tirbanibulin
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Investigational medicinal product code |
M-14789-42
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Other name |
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Pharmaceutical forms |
Ointment
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Routes of administration |
Cutaneous use
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Dosage and administration details |
Subjects applied tirbanibulin ointment- topically once daily to a contiguous area of up to 25 square centimeter (cm^2) area of the face or scalp.
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| Notes [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Milestones in this study were added as per the analysis population set. |
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Baseline characteristics reporting groups
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Reporting group title |
Tirbanibulin 2.5 mg
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Reporting group description |
Subjects applied tirbanibulin ointment- topically at a dose of 2.5 milligrams (mg) once daily for 5 consecutive days on the face or scalp. | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tirbanibulin 2.5 mg
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Reporting group description |
Subjects applied tirbanibulin ointment- topically at a dose of 2.5 milligrams (mg) once daily for 5 consecutive days on the face or scalp. | ||
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End point title |
Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57 [1] | ||||||||||||||
End point description |
TSQM-9 was a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. TSQM-9 measures subject satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain (1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction). The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement. Evaluable population.
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End point type |
Primary
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End point timeframe |
At Day 57
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57 | ||||||||||||||
End point description |
Skindex-16 was used for subjects to rate skin conditions that have occurred within the previous week. The Skindex-16 consisted of 16 items that were divided into three sub-scores: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30). Subject were asked to respond on how much their skin condition bothered them in the week prior to administration of the Skindex-16. Each item was scored on a scale ranged from 0 (never bothered) to 6 (always bothered), where higher score indicated continued/more botheration. Item scores are transformed to 0 to 100 scale, and domain scores are calculated as the average of the item scores comprising the domain. Net positive changes in respective subscale scoring indicates improvement in that particular Quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring indicates decrease in that particular Quality of life assessment. Evaluable population.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 57
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Percentage of Subjects With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Likert scale was an instrument used to measure the individual's degree of agreement and disagreement with a variety of statements about some attitude, options, or their feelings. In this study, the product's organoleptic properties are evaluated with Likert scale. The questionnaire was built with questions related to the product's characteristics namely appearance, color, convenience, texture, smell, and the feelings experienced during drug application. The Likert scale offers 7 possible answers, from "totally agree",' In agreement", "Somewhat agree", "Neither agree nor disagree", "Something in disagreement", "In disagreement" and "totally in disagreement". Evaluable population. Here "number of subjects analyzed" signifies subjects who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
At Day 8
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57 | ||||||||||||||||
End point description |
TSQM 1.4 was a 14-item robust instrument that psychometrically evaluates the treatment satisfaction of the administered medication. The instrument is designed with 4 scales consisting of 14 questions. These 14 questions were derived from an original set of 55 questions extracted from exhaustive literature review and treatment groups through multistep iterative process. The 4 scales focused on effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. Evaluable population.
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End point type |
Secondary
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End point timeframe |
At Day 57
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of Patients who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Expert panel on consensus developed a questionnaire directed to patients consisting of 9 simple items using a qualitative modified delphi method and agreed to ask 9 specific items; 1: Overall appearance of the skin (much worse to much improved); 2: Treatment satisfaction of skin looks (extremely dissatisfied to extremely satisfied); 3: Treatment satisfaction of skin texture (extremely dissatisfied to extremely satisfied); 4: Duration of skin reactions (much shorter to much longer); 5: rate the severity of skin reactions (much better to much worse); 6: impact on your daily activities due to skin reactions (much better to much worse); 7: rate the convenience/ease of use (much better to much worse); 8: rate your overall satisfaction (much better to much worse); 9: You need to be retreated for AK, how likely are you to consider tirbanibulin (very unlikely to very likely). Evaluable population. Here, "n" signifies subjects who were evaluable at specific category.
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End point type |
Secondary
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End point timeframe |
At Day 57
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Expert panel on consensus developed a questionnaire directed to physicians consisting of 10 simple items using a qualitative modified delphi method and agreed to ask 10 specific items-1: Overall appearance of the skin (much worse to much improved); 2: Treatment satisfaction of skin looks (extremely dissatisfied-extremely satisfied); 3: Treatment satisfaction of skin texture (extremely dissatisfied-extremely satisfied); 4: Duration of skin reactions (much shorter-much longer); 5: rate the severity of skin reactions (much better-much worse); 6: impact on patient's daily activities due to skin reactions (much better-much worse); 7: rate the convenience/ease of use (much better-much worse); 8: rate your overall satisfaction (much better-much worse); 9: patient needs to be retreated for AK, how likely to consider tirbanibulin (very unlikely-very likely);10: severity of skin photodamage in the original AK treated area (absent-severe). Evaluable population.
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End point type |
Secondary
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End point timeframe |
At Day 57
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Complete (100%) Clearance of All Lesions Within the Application Area at Day 57 | ||||||||
End point description |
Complete clearance of all AK lesions within the application area, is defined as a reduction from baseline in the number of lesions = 100% at Day 57. Percentage of subjects with complete clearance with a reduction of 100% (i.e., clearance percentage = 100% from Baseline) in the number of lesions within the application area were reported. Evaluable population.
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End point type |
Secondary
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End point timeframe |
At Day 57
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects With Partial Clearance (Reduction of at Least >=75% to <100%) of All Lesions Within the Application Area at Day 57 | ||||||||
End point description |
Subjects with partial clearance were patients with a reduction of >=75% (i.e., clearance percentage <=-75% from Baseline) to <100% in the number of lesions within the application area at final visit. Evaluable population.
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End point type |
Secondary
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End point timeframe |
At Day 57
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| No statistical analyses for this end point | |||||||||
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End point title |
Percent Change From Baseline in Mean Number of Old and New AK Lesions at Day 57 | ||||||||
End point description |
Percent change from baseline in number of old and new AK lesions at Day 57 was reported. Number of lesions at Day 57 was calculated considering both old and new lesions, as: N lesions at Baseline - N lesions at Day 57/ N lesions at Baseline * 100%. Evaluable population.
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End point type |
Secondary
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End point timeframe |
At Day 57
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects by Olsen characterization at Baseline and Day 57 | ||||||||||||||||||||
End point 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). Evaluable population.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 0) and Day 57
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Percentage of Subjects Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint | ||||||||||||||||||
End point description |
LC-OCT was a novel non-invasive imaging technique that enables in vivo visualization of the skin. It has been used for diagnosing and monitoring the treatment of skin disorders, including actinic keratosis. The use of LC-OCT in AK treatment progression allows for lesion classification based on histological features without the need for a biopsy. The histopathology of the skin was evaluated based on the estimated atypia score at cellular level of the LC-OCT images of clinical and subclinical lesions. Percentage of participants who performed LC-OCT for clinical and subclinical lesions assessment at each timepoint were reported. LC-OCT population consisted of FAS participants who performed at least one valid LC-OCT assessment.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 8, Day 15, Day 29, and Day 57
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs | ||||||||||||||||
End point description |
An adverse event (AE) is as any untoward medical occurrence associated with the use of an intervention in humans after providing written informed consent for subjects in the study until the end of study visit, whether considered intervention-related or not. A TEAE is defined as an AE with an onset that occurs after receiving study drug. Severity of TEAEs is graded as follows: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated. Safety population consisted of FAS subjects.
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End point type |
Secondary
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End point timeframe |
From start of study administration up to Day 57
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| No statistical analyses for this end point | |||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From start of study administration up to Day 57
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.0
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Reporting groups
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Reporting group title |
Tirbanibulin 2.5 mg
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Reporting group description |
Participants applied tirbanibulin ointment- topically at a dose of 2.5 mg once daily for 5 consecutive days on the face or scalp. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
