Keratosis, Actinic
Conditions
Brief summary
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).
Interventions
DRUGTirbanibulin
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.
Sponsors
Almirall, S.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with AK of the face or scalp * Has clinically typical, visible, and discrete AK lesions * Considered as a potential candidate for tirbanibulin (Klisyri®) treatment to manage their AK * Willing to avoid excessive sun or ultraviolet (UV) exposure, and/or use relevant sunscreen protection and protective clothing during the study duration * Able to read and write English * Provide consent to participate in the study * Willing to comply with all study procedures and be available for the duration of the study
Exclusion criteria
* Participants with any dermatological condition of the face or scalp that could interfere with the clinical evaluations. * Hypertrophic AK lesions, open wounds or suspected skin cancers within close proximity of the treatment area. * Anticipated need for in-patient hospitalization or in-patient surgery within the next 2 months. * Participants unable to comply with the requirements of the study or participants who in the opinion of the study physician should not participate in the study. * Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8 | 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 32 sites in the United States from 9 March 2022 to 7 March 2023.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 290 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Tirbanibulin |
|---|---|
| Age, Continuous | 66.30 years STANDARD_DEVIATION 11.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 269 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants |
| Race/Ethnicity, Customized Race Prefer not to answer | 3 Participants |
| Race/Ethnicity, Customized Race White | 285 Participants |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 199 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 300 |
| other Total, other adverse events | 9 / 300 |
| serious Total, serious adverse events | 6 / 300 |
Outcome results
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.
Time frame: Baseline, Week 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tirbanibulin | Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 | Symptoms Domain Score: Baseline | 22.30 score on a scale | Standard Deviation 22.36 |
| Tirbanibulin | Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 | Symptoms Domain Score: Change at Week 8 | -14.26 score on a scale | Standard Deviation 27.77 |
| Tirbanibulin | Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 | Emotions Domain Score: Baseline | 38.17 score on a scale | Standard Deviation 27.3 |
| Tirbanibulin | Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 | Emotions Domain Score: Change at Week 8 | -24.88 score on a scale | Standard Deviation 32.96 |
| Tirbanibulin | Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 | Functioning Domain Score: Baseline | 14.41 score on a scale | Standard Deviation 20.06 |
| Tirbanibulin | Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 | Functioning Domain Score: Change at Week 8 | -9.78 score on a scale | Standard Deviation 23.66 |
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.
Time frame: At Week 8
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tirbanibulin | Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8 | 73.79 percentage of participants |