Keratosis, ActinicPROAKNCT05260073
Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis
An observational study of Keratosis, Actinic, run by Almirall, S.A. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratosis, Actinic
- What is being tested?
- Tirbanibulin
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 7 Mar 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Almirall Investigational Site 1
Charleston, South Carolina, 29401
About this study
Official title: A Prospective Cohort Study of Patients With Actinic Keratosis (AK) in the Face or Scalp Treated With Tirbanibulin and Followed for 24 Weeks Post Treatment-initiation. Patient Reported Outcomes (PROs) and Clinical Profile of Patients Will be Gathered for Descriptive Analyses of Patient Outcomes Over the 24-week Study Observation Period
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).
- Conditions
- Keratosis, Actinic
- Being tested
- Tirbanibulin
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirbanibulinDrug
Also called Klisyri®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tirbanibulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8
Secondary outcomes (1)
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.
Measured: At Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start9 Mar 2022
- Primary completion31 Oct 2022
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Keratosis, ActinicStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260073
- Sponsor's protocol ID
- M-14789-43
- Acronym
- PROAK
- Status last verified
- May 2024
- First submitted
- 18 Feb 2022
- Last updated
- 20 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 39040844
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Patients With Actinic Keratosis (AK) in the Face or Scalp Treated With Tirbanibulin and Followed for 24 Weeks Post Treatment-initiation. Patient Reported Outcomes (PROs) and Clinical Profile of Patients Will be Gathered for Descriptive Analyses of Patient Outcomes Over the 24-week Study Observation Period
- ClinicalTrials.gov ID
- NCT05260073
- Acronym / sponsor ID
- PROAK / M-14789-43
- Conditions
- Keratosis, Actinic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Posted 20 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tirbanibulin | – | Drug: TirbanibulinParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirbanibulinAlso: Klisyri®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. | Drug | Tirbanibulin |
Primary outcome
Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8
Time frame: 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.
1 secondary outcome
Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8
Time frame: At Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39040844Berman 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.
- Individual participant dataSharing planned: No
Related trials for Keratosis, Actinic
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratosis, Actinic, run by Almirall, S.A. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.