NCT05260073: PROAK

Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis

Completed Results posted Last updated 20 September 2024

What this trial tests

trial testing Tirbanibulin in Keratosis, Actinic in 300 participants. Completed in 7 March 2023.

Timeline

9 March 2022

Primary endpoint
31 October 2022

7 March 2023

Quick facts

Lead sponsor	Almirall, S.A.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	300
Start date	9 March 2022
Primary completion	31 October 2022
Estimated completion	7 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Tirbanibulin (TIRBANIBULIN) — full drug profile →

Conditions studied

• Keratosis, Actinic — all drugs for Keratosis, Actinic →

Sponsor

Almirall, S.A. — full company profile →

Who can join

18 and older, any sex, with Keratosis, Actinic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 Primary · 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 sco

Symptoms Domain Score: Baseline

Group	Value	95% CI
Tirbanibulin	22.30	± 22.36

Symptoms Domain Score: Change at Week 8

Group	Value	95% CI
Tirbanibulin	-14.26	± 27.77

Emotions Domain Score: Baseline

Group	Value	95% CI
Tirbanibulin	38.17	± 27.30

Emotions Domain Score: Change at Week 8

Group	Value	95% CI
Tirbanibulin	-24.88	± 32.96

Functioning Domain Score: Baseline

Group	Value	95% CI
Tirbanibulin	14.41	± 20.06

Functioning Domain Score: Change at Week 8

Group	Value	95% CI
Tirbanibulin	-9.78	± 23.66

Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8 Secondary · 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.

Group	Value	95% CI
Tirbanibulin	73.79

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of study up to end of the study (Week 24). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tirbanibulin

Serious: 6/300 (2%)

Deaths: 0/300

Serious adverse events (5 terms)

Reaction	System	Tirbanibulin
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Fall	Injury, poisoning and procedural complications	—
Bowen's Disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (5 terms — click to expand)

Reaction	System	Tirbanibulin
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
COVID-19	Infections and infestations	—
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Capillary fragility	Vascular disorders	—
Angioedema	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Squamous Cell Carcinoma, Basal Cell Carcinoma, Fall, Bowen's Disease, Pneumothorax.

Data from ClinicalTrials.gov NCT05260073 adverse events section.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tirbanibulin for Actinic Keratosis: Insights into the Mechanism of Action.
   Schlesinger T, Stockfleth E, Grada A, Berman B. · · 2022 · cited 30× · PMID 36415541 · DOI 10.2147/ccid.s374122
2. Developing a questionnaire for assessing clinician- and patient-reported outcomes in actinic keratosis: Results from an expert panel.
   Berman B, Armstrong A, Lebwohl M, Grada A, et al · · 2024 · cited 1× · PMID 39040844 · DOI 10.1016/j.jdin.2023.09.006
3. Selected Poster Abstracts from MauiDerm 2023 for Dermatologists
   · 2023