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Skin cancer is a type of cancer that occurs when there is an abnormal growth of skin cells, usually triggered by damage to the DNA within the skin cells. It is primarily caused by exposure to ultraviolet (UV) radiation from the sun or artificial sources like tanning beds. Skin cancer is the most common type of cancer worldwide, and its incidence continues to rise.
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  1. Home
  3. 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.
  1. Home
  3. 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.

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Safety and tolerability of tirbanibulin ointment 1% treatment on 100 cm2 of the face or scalp in patients with

Neal Bhatia1, Edward Lain2,3, Abel Jarell4

  • 1Therapeutics Clinical Research, San Diego, California.

JAAD International
|September 13, 2024

View abstract on PubMed

Summary
This summary is machine-generated.

Tirbanibulin effectively treated actinic keratosis (AK) on larger skin fields up to 100 cm², showing safety and tolerability comparable to smaller areas. This suggests its potential for treating extensive AK.

Keywords:
UV light-damaged skinactinic keratosisfaceprecancerous skin diseasesafetyscalptirbanibulintolerabilitytreatment field

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Area of Science:

  • Dermatology
  • Oncology
  • Pharmacology

Background:

  • Tirbanibulin is FDA-approved for actinic keratosis (AK) field treatment on areas up to 25 cm².
  • Actinic keratosis frequently affects larger skin areas, necessitating treatments for extensive fields.
  • Current treatment options for large-field AK are limited, creating a need for expanded therapeutic approaches.

Purpose of the Study:

  • To evaluate the safety and tolerability of tirbanibulin when applied to a larger treatment field of approximately 100 cm².
  • To assess the efficacy of tirbanibulin in reducing the number of actinic keratosis lesions in a larger field.
  • To compare the safety and tolerability profile of tirbanibulin on larger fields with existing data from smaller treatment areas.

Main Methods:

  • A Phase 3, multicenter, open-label, single-arm study was conducted.
  • 105 adult patients with 4-12 AKs on the face or balding scalp within a 100 cm² treatment field were enrolled.
  • Patients applied tirbanibulin once daily for 5 consecutive days; safety and tolerability were assessed via adverse events and local tolerability signs (LTS).

    • Main Results:

    • The most common local tolerability signs were mild-to-moderate erythema (96.1%) and flaking/scaling (84.4%), which resolved by Day 29.
    • Severe local tolerability signs included erythema (5.8%) and flaking/scaling (8.7%).
    • Mean AK count decreased from 7.7 at baseline to 1.8 at Day 57, representing a 77.8% reduction; common adverse events were application site pruritus and pain.

    Conclusions:

    • Tirbanibulin demonstrated a safety and tolerability profile consistent with previous studies on smaller fields when used on larger areas (up to 100 cm²).
    • The study supports the potential use of tirbanibulin for treating actinic keratosis on larger skin fields exceeding the currently approved 25 cm².
    • Further research with a control group and long-term follow-up is warranted to fully establish efficacy and safety for extended field treatments.