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The purpose of the study is to evaluate patient reported outcomes (PROs) in terms of health-related quality of life (HRQoL) among subjects with actinic keratosis (AK).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirbanibulin | Participants will receive tirbanibulin ointment 2.5 mg in 250 mg (single dose packet). The participants will be observed for 24 weeks to gather participant reported outcomes (PROs) and clinical profile. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirbanibulin | Drug | Participants will be treated with tirbanibulin ointment 1% (2.5 mg tirbanibulin in 250 mg) as 1 single-dose packet per application, for 5 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 | Skindex-16 is a validated dermatological instrument to measure dermatology-specific Health-Related Quality of Life (HRQoL). The Skindex-16 consisted of 16 items that were divided into three domains: 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. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8 | IGA success was defined as achieving a rating of 'completely cleared' (0) or 'partially cleared' (1) in IGA of AK status at Week 8. The IGA is 5-point scale that assessed the severity of actinic keratosis, with scores ranged from 0 (completely clear) to 4 (not cleared): 0 = completely cleared (100% clearance); 1 = partially cleared (>=75% clearance); 2 = moderately cleared (50% to 74% clearance); 3 = minimally cleared (<50% clearance); 4 = not cleared (0% clearance), where higher score indicated higher severity. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be participants diagnosed with AK on the face or scalp, and aged 18 years or above at the time of initiation of treatment. The study cohort will be drawn from dermatology clinics from across the U.S.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall Investigational Site 1 | Charleston | South Carolina | 29401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39040844 | Derived | Berman B, Armstrong A, Lebwohl M, Grada A, Bhatia N, Patel VA, Rigel D, Del Rosso J, Schlesinger T, Kircik L, Salem R, Narayanan S, Kasujee I. Developing a questionnaire for assessing clinician- and patient-reported outcomes in actinic keratosis: Results from an expert panel. JAAD Int. 2023 Sep 23;16:192-198. doi: 10.1016/j.jdin.2023.09.006. eCollection 2024 Sep. |
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A total of 300 participants were enrolled, out of which 290 participants who completed the week 8 study survey were included in the full analysis set.
This study was conducted at 32 sites in the United States from 9 March 2022 to 7 March 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tirbanibulin | Participants with actinic keratosis (AK) applied tirbanibulin ointment 1% topically once daily using 1 single-dose packet (2.5 milligrams [mg] in 250 mg) per application, for 5 consecutive days were observed for 24 weeks to gather participant reported outcomes (PROs) and clinical profile. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
FAS included all participants who received at least one dose of tirbanibulin during the study observation period of 8-weeks related to primary endpoint, as part of usual care and had at least some data pertaining to the key variables studied at relevant timepoints, post-baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tirbanibulin | Participants with AK applied tirbanibulin ointment 1% topically once daily using 1 single-dose packet (2.5 mg in 250 mg) per application, for 5 consecutive days were observed for 24 weeks to gather PROs and clinical profile. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 | Skindex-16 is a validated dermatological instrument to measure dermatology-specific Health-Related Quality of Life (HRQoL). The Skindex-16 consisted of 16 items that were divided into three domains: 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. | FAS included all participants who received at least one dose of tirbanibulin during the study observation period of 8-weeks related to primary endpoint, as part of usual care and had at least some data pertaining to the key variables studied at relevant timepoints, post-baseline. Here, "number analyzed" signifies participants who were evaluable at each specified category. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
From start of study up to end of the study (Week 24)
Safety population included all participants who received at least one dose of tirbanibulin during the study observation period of 8-weeks related to primary endpoint, as part of usual care.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tirbanibulin | Participants with AK applied tirbanibulin ointment 1% topically once daily using 1 single-dose packet (2.5 mg in 250 mg) per application, for 5 consecutive days were observed for 24 weeks to gather PROs and clinical profile. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA, version 22.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA, version 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Global Clinical Development | Almirall S.A. | +34932913000 | rd@almirall.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 11, 2022 | May 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2022 | May 14, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000713668 | tirbanibulin |
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|
| At Week 8 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Secondary | Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8 | IGA success was defined as achieving a rating of 'completely cleared' (0) or 'partially cleared' (1) in IGA of AK status at Week 8. The IGA is 5-point scale that assessed the severity of actinic keratosis, with scores ranged from 0 (completely clear) to 4 (not cleared): 0 = completely cleared (100% clearance); 1 = partially cleared (>=75% clearance); 2 = moderately cleared (50% to 74% clearance); 3 = minimally cleared (<50% clearance); 4 = not cleared (0% clearance), where higher score indicated higher severity. | FAS included all participants who received at least one dose of tirbanibulin during the study observation period of 8-weeks related to primary endpoint, as part of usual care and had at least some data pertaining to the key variables studied at relevant timepoints, post-baseline. | Posted | Number | percentage of participants | At Week 8 |
|
|
|
| 0 |
| 300 |
| 6 |
| 300 |
| 9 |
| 300 |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 22.0 | Non-systematic Assessment |
|
| Bowen's Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 22.0 | Non-systematic Assessment |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 22.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA, version 22.0 | Non-systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 22.0 | Non-systematic Assessment |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 22.0 | Non-systematic Assessment |
|
| Capillary fragility | Vascular disorders | MedDRA, version 22.0 | Non-systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA, version 22.0 | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |