Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Jul 18:17:6-14.
doi: 10.1016/j.jdin.2024.07.001. eCollection 2024 Dec.

Safety and tolerability of tirbanibulin ointment 1% treatment on 100 cm2 of the face or scalp in patients with actinic keratosis: A phase 3 study

Neal Bhatia  1 , Edward Lain  2   3 , Abel Jarell  4 , Janet DuBois  5 , Maria Luisa Tamarit  6 , Meritxell Falques  6 , Vera Kiyasova  6 , Laura Padullés  7 , Raquel Otero  6 , Andrew Blauvelt  8
Affiliations

Safety and tolerability of tirbanibulin ointment 1% treatment on 100 cm2 of the face or scalp in patients with actinic keratosis: A phase 3 study

Neal Bhatia et al. JAAD Int. .

Abstract

Background: Tirbanibulin is approved for actinic keratosis (AK) field treatment up to 25 cm2. However, AK often affects larger areas; thus, AK treatments for larger fields are needed.

Objective: Evaluate the safety and tolerability of tirbanibulin when applied to a field of approximately 100 cm2.

Methods: Phase 3, multicenter, open-label, single-arm study among adult patients having a treatment field on the face or balding scalp of approximately 100 cm2 with 4-12 AKs. Patients received tirbanibulin to cover the treatment field once daily (5 consecutive days). Safety was assessed by evaluating treatment emergent adverse events and tolerability by composite score of 6 local tolerability signs (LTS).

Results: A total of 105 patients were included. The most common LTS were erythema (96.1%) and flaking/scaling (84.4%), being mostly mild-to-moderate severity, and resolved/returned to or close to baseline by Day 29. The only severe LTS were erythema (5.8%) and flaking/scaling (8.7%). Most frequent treatment emergent adverse events were application site pruritus (10.5%) and application site pain (8.6%). Mean total number of AKs decreased from 7.7 AKs at baseline to 1.8 AKs at Day 57. Mean percent of change (reduction) from baseline in lesion count was 77.8% at Day 57.

Limitations: No control group. No long-term follow-up.

Conclusion: Safety and tolerability profiles in patients treated with tirbanibulin up to 100 cm2 were consistent with those previously reported over smaller field. Tirbanibulin could be used on a larger field (>25 cm2).

Keywords: UV light-damaged skin; actinic keratosis; face; precancerous skin disease; safety; scalp; tirbanibulin; tolerability; treatment field.

PubMed Disclaimer

Conflict of interest statement

Dr Bhatia is a consulting honoraria from and investigator for Almirall, Biofrontera, Leo, Ortho, and Sun Pharma. Dr Blauvelt is a speaker (received honoraria) for AbbVie, Eli Lilly and Company, Pfizer, and UCB; scientific adviser (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Lipidio, Microbion, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Q32 Bio, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor; and clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma, and Ventyx. Dr Lain is a clinical investigator, consultant, advisor, and/or paid speaker for Almirall, Athenex, Gage Pharmaceuticals, UCB, Abbvie, Sanofi, Regeneron, Vyne Pharmaceuticals, Pfizer, Amgen, Novartis, Eli Lilly, Kadmon, Chemocentryx, Bausch Health, Galderma, Dermavant, Arcutis, Bristol Myers Squibb, Kiniksa, Mindera, Sebacia, Pulse BioSciences, Leo Pharmaceuticals, Aclaris, Biorasi, Brickell, Cassiopea, Dr Reddy, Endo Pharmaceuticals, and G&E Herbal Biotechnology. Dr Jarell is an investigator of or received grants/research funding from AbbVie, Almirall, Arcutis Biotherapeutics, Arcutis, Inc, Asana Biosciences, LLC, BMS, Castle Biosciences, Concert Pharmaceuticals, Dermira, Foamix Pharmaceuticals Ltd, Incyte Corporation, Leo Pharma Inc, Lilly ICOS LLC, Novartis, Sanofi/Regeneron, UCB, Vivex Biomedical, Inc. Dr DuBois is an investigator of or received grants/research funding from AbbVie, AiViva BioPharma, Allergan, Inc, Almirall, AnaptysBio, Arcutis Biotherapeutics, Bausch Health, Biofrontera, Bristol-Myers Squibb, Caliway Biopharmaceuticals Co, Ltd, Cara Therapeutics, Croma-Pharma GmbH Austria, Dermata Therapeutics, DermBiont, Dr Reddy, Endo Pharmaceuticals, Evommune, Inc., Galderma USA, Incyte Corporation, LEO Laboratories Ltd (LEO Pharma), Merck, Moberg Pharma, Palvella Therapeutics, RAPT Therapeutics, Scarless Laboratories, Therapeutics Inc, Veradermics Inc. Drs Tamarit, Falques, Kiyasova, Padulles, and Otero are employees of Almirall Spain.

Figures

Fig 1
Fig 1
Actinic keratosis. Patient flow diagram.
Fig 2
Fig 2
Actinic keratosis. Maximum local tolerability score throughout study (safety population, N = 105).
Fig 3
Fig 3
Actinic keratosis. Evolution of the local tolerability signs across the study (safety population, N = 105).
Fig 4
Fig 4
Actinic keratosis. A-D, Pre- and post-treatment appearance and changes during the study in 4 cases of the treated sample.
Fig 5
Fig 5
Actinic keratosis. Mean percentage change from baseline in lesion count by visit and by subgroups of patients at Day 57 (N = 102).
See this image and copyright information in PMC

References

    1. Siegel J.A., Korgavkar K., Weinstock M.A. Current perspective on actinic keratosis: a review. Br J Dermatol. 2017;177(2):350–358. doi: 10.1111/bjd.14852. - DOI - PubMed
    1. Fernandez Figueras M.T. From actinic keratosis to squamous cell carcinoma: pathophysiology revisited. J Eur Acad Dermatol Venereol. 2017;31(Suppl 2):5–7. doi: 10.1111/jdv.14151. - DOI - PubMed
    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 (Kaunas) 2019;55(4):92. doi: 10.3390/medicina55040092. - DOI - PMC - PubMed
    1. Eisen D.B., Asgari M.M., Bennett D.D., et al. Guidelines of care for the management of actinic keratosis. J Am Acad Dermatol. 2021;85(4):e209–e233. doi: 10.1016/j.jaad.2021.02.082. - DOI - PubMed
    1. Eisen D.B., Dellavalle R.P., Frazer-Green L., Schlesinger T.E., Shive M., Wu P.A. Focused update: guidelines of care for the management of actinic keratosis. J Am Acad Dermatol. 2022;87(2):373–374.e5. doi: 10.1016/j.jaad.2022.04.013. - DOI - PubMed

LinkOut - more resources