A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses
- Registration Number
- NCT05741294
- Lead Sponsor
- Almirall, S.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 334
- 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.
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Clinically atypical and/or rapidly changing AK lesions.
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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).
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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.
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History of sensitivity to any of the ingredients in the tirbanibulin formulation.
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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.
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Participants with a history of tirbanibulin treatment for AK lesions and participants who are currently on tirbanibulin treatment for AK lesions.
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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.
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Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit.
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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.
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Females who are pregnant or nursing.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tirbanibulin 2.5 milligrams (mg) ointment Tirbanibulin 2.5 mg ointment Participants will apply tirbanibulin ointment- topically at a dose of 2.5 mg once daily for 5 consecutive days- on the face or scalp.
- Primary Outcome Measures
Name Time Method Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57 At Day 57 TSQM-9 was a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 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 then 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57 Baseline, Day 57 Skindex-16 was used for participants 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). Participant 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.
Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8 At Day 8 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".
Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57 At Day 57 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.
Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57 At Day 57 An expert panel on consensus developed a questionnaire directed to patients consisting of 9 simple items using a qualitative modified delphi method. Expert panel 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).
Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57 At Day 57 An expert panel on consensus developed a questionnaire directed to physicians consisting of 10 simple items using a qualitative modified delphi method. Expert panel 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 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 patient's 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: patient needs to be retreated for AK, how likely to consider tirbanibulin (very unlikely to very likely);10: severity of skin photodamage in the original AK treated area (absent to severe).
Percentage of Participants With Complete (100%) Clearance of All Lesions Within the Application Area at Day 57 At Day 57 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 participants 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.
Percentage of Participants With Partial Clearance (Reduction of at Least >=75% to <100%) of All Lesions Within the Application Area at Day 57 At Day 57 Participants 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.
Percent Change From Baseline in Mean Number of Old and New AK Lesions at Day 57 At Day 57 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%.
Percentage of Participants by Olsen Characterization at Baseline and Day 57 Baseline (Day 0) and 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).
Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint Baseline, Day 8, Day 15, Day 29, and Day 57 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs From start of study administration up to Day 57 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 participation 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.
Trial Locations
- Locations (30)
Almirall Investigational Site 1
🇪🇸Alcorcón, Spain
Almirall Investigational Site 2
🇪🇸Alicante, Spain
Almirall Investigational Site 3
🇪🇸Badalona, Spain
Almirall Investigational Site 4
🇪🇸Barcelona, Spain
Almirall Investigational Site 5
🇪🇸Barcelona, Spain
Almirall Investigational Site 6
🇪🇸Barcelona, Spain
Almirall Investigational Site 7
🇪🇸Barcelona, Spain
Almirall Investigational Site 8
🇪🇸Bilbao, Spain
Almirall Investigational Site 9
🇪🇸Córdoba, Spain
Almirall Investigational Site 10
🇪🇸Fuenlabrada, Spain
Almirall Investigational Site 11
🇪🇸Granada, Spain
Almirall Investigational Site 12
🇪🇸Madrid, Spain
Almirall Investigational Site 13
🇪🇸Madrid, Spain
Almirall Investigational Site 14
🇪🇸Madrid, Spain
Almirall Investigational Site 15
🇪🇸Madrid, Spain
Almirall Investigational Site 16
🇪🇸Majadahonda, Spain
Almirall Investigational Site 17
🇪🇸Málaga, Spain
Almirall Investigational Site 18
🇪🇸Palma, Spain
Almirall Investigational Site 19
🇪🇸Pontevedra, Spain
Almirall Investigational Site 20
🇪🇸Sabadell, Spain
Almirall Investigational Site 21
🇪🇸Salamanca, Spain
Almirall Investigational Site 22
🇪🇸Santa Cruz de Tenerife, Spain
Almirall Investigational Site 23
🇪🇸Sevilla, Spain
Almirall Investigational Site 24
🇪🇸Sevilla, Spain
Almirall Investigational Site 25
🇪🇸Valencia, Spain
Almirall Investigational Site 26
🇪🇸Valencia, Spain
Almirall Investigational Site 27
🇪🇸Valencia, Spain
Almirall Investigational Site 28
🇪🇸Vigo, Spain
Almirall Investigational Site 29
🇪🇸Zaragoza, Spain
Almirall Investigational Site 30
🇪🇸Zaragoza, Spain