Clinician- and Patient-Reported Outcomes with Tirbanibulin 1% Treatment for Actinic Keratosis in Routine Clinical Practice Across the U.S. (PROAK Study)

Main Article Content

Todd Schlesinger
Leon Kircik
James Del Rosso
Darrell Rigel
Mark Lebwohl
Brian Berman
April Armstrong
Neal Bhatia
Vishal A. Patel
Siva Narayanan
Volker Koscielny
Ismail Kasujee


actinic keratosis, topical treatment, tirbanibulin, patient-reported outcomes, clinician-reported outcomes


Background: Patients' experiences regarding topical actinic keratosis (AK) treatments may optimize clinical outcomes. PROAK study aimed to evaluate patient- and clinician-reported outcomes among adult patients with AK on face or scalp who were prescribed tirbanibulin in real-world clinical practice in the United States.

Methods: Key primary endpoint was quality of life (QoL) assessed by Skindex-16. Additional endpoints were tirbanibulin treatment effectiveness and satisfaction (Treatment Satisfaction Questionnaire for Medication and Expert Panel Questionnaire).

Results: 290 patients were included in this analysis. At week 8, Skindex-16 scores improved in all domains (mean change from baseline [standard deviation, SD]: -14.3 [27.8] in symptoms, -24.9 [33.0] in emotions, and -9.8 [23.7] in functioning domain). Clinicians and patients reported high global satisfaction with tirbanibulin (mean [SD] scores of 78.8 [20.1] and of 74.5 [23.5]). Overall skin appearance improved from baseline to week 8 (91.0% clinicians; 84.1% patients). In comparison with previous treatments, tirbanibulin had shorter skin reactions duration (89.2% clinicians; 73.9% patients); milder skin reaction severity (91.0% clinicians; 76.6% patients); better daily activities impact (87.4% clinicians; 64.0% patients); and was easier to use (88.3% clinicians; 71.2% patients).  Investigator’s Global Assessment (IGA) success (0-1) was achieved by 73.8% of the patients. Skin photodamage severity reduction from baseline to week 8 was significant (77.4% vs. 39.6%; p<0.0001).

Conclusions: Tirbanibulin treatment demonstrated effectiveness in AK management. Moreover, tirbanibulin improved QoL, as early as week 8, and both clinicians and patients reported tirbanibulin treatment convenience, and high levels of treatment satisfaction, compared to patient’s previous treatments.


1. Balcere A, Rone Kupfere M, Čēma I, Krūmiņa A. Prevalence, Discontinuation Rate, and Risk Factors for Severe Local Site Reactions with Topical Field Treatment Options for Actinic Keratosis of the Face and Scalp. Medicina. 2019;55(4):92.

2. Dao DPD, Sahni VN, Sahni DR, Balogh EA, Grada A, Feldman SR. 1% Tirbanibulin Ointment for the Treatment of Actinic Keratoses. Ann Pharmacother. 2022;56(4):494–500.

3. Blauvelt A, Kempers S, Lain E, Schlesinger T, Tyring S, Forman S, et al. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. N Engl J Med. 2021;384(6):512–20.

4. Criscione VD, Weinstock MA, Naylor MF, Luque C, Eide MJ, Bingham SF, et al. Actinic keratoses: Natural history and risk of malignant transformation in the Veterans Affairs Topical Tretinoin Chemoprevention Trial. Cancer. 2009;115(11):2523–30.

5. Del Rosso JQ, Kircik L, Goldenberg G, Brian B. Comprehensive management of actinic keratoses: practical integration of available therapies with a review of a newer treatment approach. J Clin Aesthet Dermatol. 2014;7(9 Suppl S2-S12):S2–12.

6. Emmerich VK, Cull D, Kelly KA, Feldman SR. Patient assessment of 5-fluorouracil and imiquimod for the treatment of actinic keratoses: a retrospective study of real-world effectiveness. Journal of Dermatological Treatment. 2022;33(4):2075–8.

7. Grada A, Feldman SR, Bragazzi NL, Damiani G. Patient‐reported outcomes of topical therapies in actinic keratosis: A systematic review. Dermatologic Therapy [Internet]. 2021 [cited 2023 Mar 2];34(2). Available from:

8. Grada A, Muddasani S, Fleischer AB, Feldman SR, Peck GM. Trends in Office Visits for the Five Most Common Skin Diseases in the United States. J Clin Aesthet Dermatol. 2022;15(5):E82–6.

9. Norrlid H, Norlin JM, Holmstrup H, Malmberg I, Sartorius K, Thormann H, et al. Patient-reported outcomes in topical field treatment of actinic keratosis in Swedish and Danish patients. Journal of Dermatological Treatment. 2018;29(1):68–73.

10. Schlesinger T, Stockfleth E, Grada A, Berman B. Tirbanibulin for Actinic Keratosis: Insights into the Mechanism of Action. CCID. 2022;15:2495–506.

11. Stockfleth E, Peris K, Guillen C, Cerio R, Basset‐Seguin N, Foley P, et al. A consensus approach to improving patient adherence and persistence with topical treatment for actinic keratosis. Int J Dermatol. 2015;54(5):509–15.

12. Stockfleth E, von Kiedrowski R, Dominicus R, Ryan J, Ellery A, Falqués M, et al. Efficacy and Safety of 5-Fluorouracil 0.5%/Salicylic Acid 10% in the Field-Directed Treatment of Actinic Keratosis: A Phase III, Randomized, Double-Blind, Vehicle-Controlled Trial. Dermatol Ther (Heidelb). 2017;7(1):81–96.

13. Waalboer-Spuij R, Holterhues C, van Hattem S, Schuttelaar MLA, Gaastra MTW, Kuijpers DIM, et al. Patient Perception of Imiquimod Treatment for Actinic Keratosis and Superficial Basal Cell Carcinoma in 202 Patients. Dermatology. 2015;231(1):56–62.

14. Kasujee I, Diaz Gallo C, Jose Lambert C, Massana Montejo E, Narayanan S. Patient Perception of Disease and Treatment Burden and New Treatment Preferences in Actinic Keratosis. Value in Health. 2022;25(6, S1).

15. Khanna R, Bakshi A, Amir Y, Goldenberg G. Patient satisfaction and reported outcomes on the management of actinic keratosis. CCID. 2017;10:179–84.

16. Bhatia N, Armstrong AW, Schlesinger T, Kircik L, Berman B, Lebwohl M, et al. An Expert Panel Questionnaire for Assessing Patient-Reported and Clinician-Reported Outcomes in Actinic Keratosis. J of Skin. 2022;6(6):s89.

17. Kempers S, DuBois J, Forman S, Poon A, Cutler E, Wang H, et al. Tirbanibulin Ointment 1% as a Novel Treatment for Actinic Keratosis: Phase 1 and 2 Results. JDD. 2020;19(11):1093–100.

18. Marson J, Del Rosso J, Bhatia N, Rigel D. Considerations in the Management of Actinic Keratoses: The Importance of Adherence and Persistence to Therapy. J of Skin. 2021;5(2):83–9.

19. Berman B, Armstrong A, Lebwohl M, Grada A, Bhatia N, Patel V, et al. Patient-Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis in Real-world Settings: PROAK Study Protocol. J of Skin. 2022;6(2):s19.

20. Esmann S, Vinding GR, Christensen KB, Jemec GBE. Assessing the influence of actinic keratosis on patients’ quality of life: the AKQoL questionnaire: The AKQoL questionnaire. British Journal of Dermatology. 2013;168(2):277–83.

21. Bharmal M, Payne K, Atkinson MJ, Desrosiers MP, Morisky DE, Gemmen E. Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications. Health Qual Life Outcomes. 2009;7(1):36.

22. Chren MM, Lasek RJ, Sahay AP, Sands LP. Measurement properties of skindex-16: A brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg. 2001;5(2):105–10.

23. Chren MM, Sahay AP, Bertenthal DS, Sen S, Seth Landefeld C. Quality-of-Life Outcomes of Treatments for Cutaneous Basal Cell Carcinoma and Squamous Cell Carcinoma. Journal of Investigative Dermatology. 2007;127(6):1351–7.

24. Ahmady S, Jansen MHE, Nelemans PJ, Essers BAB, Kessels JPHM, Kelleners-Smeets NWJ, et al. The Effect of Four Approaches to Treat Actinic Keratosis on the Health-Related QOL, as Assessed by the Skindex-29 and Actinic Keratosis QOL. Journal of Investigative Dermatology. 2021;141(7):1830–2.

25. Jubert-Esteve E, del Pozo-Hernando LJ, Izquierdo-Herce N, Bauzá-Alonso A, Martín-Santiago A, Jones-Caballero M. Quality of Life and Side Effects in Patients with Actinic Keratosis Treated With Ingenol Mebutate: A Pilot Study. Actas Dermo-Sifiliográficas. 2015;106(8):644–50.

Similar Articles

You may also start an advanced similarity search for this article.

Most read articles by the same author(s)

1 2 3 4 5 6 7 8 9 10 > >>