INTERNAL USE

Leon Kircik, MD1; Todd Schlesinger, MD2; April Armstrong, MD3; Brian Berman, MD, PhD4; Neal Bhatia, MD5; James Del Rosso, DO6; Mark Lebwohl, MD1; Vishal A. Patel, MD7; Darrell Rigel, MD, MS1; 
Siva Narayanan, PhD8; Volker Koscielny, MD9 Ismail Kasujee PhD9

1Mount Sinai Icahn School of Medicine, New York, NY, USA; 2Clinical Research Center of the Carolinas, Charleston, SC, USA; 3Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; 4University of Miami Miller 
School of Medicine, Miami, FL, USA; 5Therapeutics Clinical Research, San Diego, CA, USA; 6JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV, USA; 7George Washington School of Medicine and Health Sciences, 

Washington, DC, USA; 8Avant Health LLC, Bethesda, MD, USA; 9Almirall SA, Barcelona, Spain.

IMPACT OF ACTINIC KERATOSIS (AK), AS MEASURED BY PATIENT-REPORTED AK SYMPTOMS, AND IMPACT ON EMOTIONS AND 
FUNCTIONING (USING SKINDEX-16) AMONG PATIENTS WITH AK ADMINISTERED TIRBANIBULIN IN REAL-WORLD COMMUNITY 

PRACTICES ACROSS THE U.S. (PROAK STUDY)

Introduction: Actinic Keratosis (AK) has been shown to negatively affect
emotional functioning and skin-related quality of life of patients1. Impact of
tirbanibulin treatment on the quality of life of patients with AKs is not
adequately understood. The primary objective of the study was to evaluate
patient-reported outcomes in terms of AK symptoms, and impact of AKs
on emotions and functioning, among AK patients treated with tirbanibulin
in community practices across the U.S. Methods: A single-arm,
prospective cohort study (PROAK) was conducted among adult patients
with AK of the face or scalp who were newly initiated with tirbanibulin
treatment in real-world practices in the U.S, as part of usual care. Patients
and clinicians completed surveys and clinical assessments at baseline,
Week-8 (timeframe for main endpoints) and Week-24. Skindex-16,
completed at baseline and Week-8, is a 16-item survey with 3 domains:
symptoms (4 items), emotions (7 items) and functioning (5 items), with
each domain score computed on a scale of 0 to 100 with higher score
indicating severe impairment due to AKs. Changes from baseline in
Skindex-16 scores were analyzed, as observed. Results: A total of 290
patients with AKs completed the study assessments at Week-8. Patient
self-reported skin-texture at baseline was – dry: 39.66%, smooth: 47.59%,
rough: 19.66%, bumpy: 18.62%, scaly: 35.17%, blistering/ peeling: 6.55%.
Baseline Skindex-16 domain scores were: symptoms: 22.30, emotions:
38.17, functioning: 14.41. At Week-8, a statistically significant (p<0.0001)
decrease in scores from baseline was observed for all Skindex-16
domains, with Week-8 domain scores being symptoms: 8.15, emotions:
13.49, functioning: 4.63. Conclusion: Patients with AKs who used once-
daily tirbanibulin treatment for 5-days reported a significant reduction in
the symptoms and emotional/functional impact domains of Skindex-16, at
Week-8.
Reference: 1. Br J Dermatol. 2013;168(2):277-283.

SYNOPSIS

CONCLUSIONS
• Within the study cohort of adult patients with AKs administered once-daily tirbanibulin treatment for 5-days as part of usual care, a significant reduction in AK burden was observed, as indicated by the improvement in AK symptoms 

and emotional/functional impact (using Skindex-16), at week-8.
• The demonstrated effectiveness and the safe and tolerable profile of once-daily tirbanibulin treatment highlights the benefits associated with this novel therapeutic option in routine community practice settings, for optimal management 

of AKs.
Sponsored by Almirall, S.A.

METHODS
• A single-arm, prospective cohort study (PROAK) was conducted among

adult patients with AKs on the face or scalp who were newly initiated with
once-daily tirbanibulin treatment (5-day course) in real-world community
practices in the U.S, as part of usual care.

• A total of 300 subjects were enrolled from 32 community practices across 
the U.S.
• Patients and clinicians completed surveys and clinical assessments at 

baseline, week-8 (timeframe for main endpoints) and week-24, 
concerning safety and effectiveness of tirbanibulin.

• Skindex-16, a validated PRO instrument, was completed by patients at 
baseline and Week-8.
• This 16-item survey has 3 domains, namely, symptom domain (4 

items), emotions domain (7 items) and functioning domain (5 items).
• All items are scored on a seven-point adjectival response scale, with 

a potential score of 0 (never bothered) to 6 (always bothered). 
• Each domain score is individually computed on a scale of 0 to 100 

with higher score indicating severe impairment due to AKs. 
• Changes from baseline in Skindex-16 domain scores at week-8 were 

analyzed, as observed. 

OBJECTIVE
• The primary objective of the study was to evaluate patient-reported 

outcomes in terms of AK symptoms, and impact of AKs on emotions and 
functioning, among AK patients treated with tirbanibulin in community 
practices across the U.S.

RESULTS
• PROAK study (NCT05260073) was initiated in 2022, with more than 75% 

of the study patients treated with tirbanibulin between April and August of 
2022.

• Out of 300 enrolled patients, a total of 290 patients with AKs completed the 
study assessments at Week-8, and hence included in the analyses.

• Overall, in 77.93% and 33.79% of study patients (not mutually 
exclusive), AK lesions on their face and scalp respectively were treated 
with tirbanibulin.

• All patients (100%) completed their 5-day once-daily treatment course.
• Ten patients were not included in the week-8 analyses: 1 patient had 

missing data, and 9 patients were discontinued from the study due to 
patient voluntary withdrawal of consent or lost to follow-up. 

• No discontinuations were related to adverse drug reactions (ADRs), and 
there were no Serious ADRs reported at week-8.

Table 1: Baseline Patient Characteristics
N=290

Age, mean years 
[min, max]

66.30 
[30.00, 90.00]

Gender, % Female
Male

31.38
68.62

Primary health    
insurance, %

Private Insurance
Medicaid
Medicare
Uninsured 

41.72
3.10
53.79
1.38

History of skin cancer, % 61.72

Fitzpatrick skin type, % 

Type I
Type II
Type III
Type IV
Type V

7.59
71.38
18.62
1.38
1.03

Baseline patient self-
reported skin-texture, % 

Dry
Smooth
Rough
Bumpy
Scaly

Blistering
Peeling

39.66
47.59
19.66
18.62
35.17
0.34
6.21

Baseline severity of skin 
photodamage in AK 

affected area, %

Absent
Mild

Moderate
Severe

1.03
21.38
56.55
20.34

22.30

38.17

14.41

8.15

13.49

4.63

0.00

10.00

20.00

30.00

40.00

50.00

Symptom Emotions Functioning

S
ki

nd
ex

D
om

ai
n 

M
ea

n 
S

co
re

Baseline

Week 8

Figure 1: Mean Skindex-16 domain scores significantly decreased 
over the 8-week study observation period

CFB: - 14.26* CFB: - 24.88* CFB: - 9.78*

N= 290; one & four patients had missing data at baseline for Symptom & Emotions domain respectively; one patient had missing data at week-8 for Emotions domain. CFB: Change from baseline to 
Week-12. *P <0.0001

Table 2: Site Characteristics (N=32)

Current workplace:
Private, office-based practice, %

100

Total number of board-certified dermatologists in the 
clinic/practice, Mean

3.53

Number of patients with AKs managed by the clinic in a 
given month, Mean

136.34

Number of years practicing dermatology, Mean 15.66