Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05900258

Acronym

SunDamage

Enrollment

Registered

2023-06-12

Start date

2023-05-11

Completion date

2023-11-13

Last updated

2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Brief summary

Interventional, monocentric, national, single-arm, uncontrolled, open, prospective phase IV study. Since this study is not powered for confirmative testing, analysis is done by descriptive statistics Eligible AK patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC. Diagnosis and monitoring of treatment effects are supported by UV imaging using Canfield VISIA®. Safety and efficacy are assessed at end of treatment visit (EoT, approximately 3 days after the last dose, i.e, day 8 ± 2) and at a follow-up visit (FuV) 57 ± 7 d after the start of the treatment. UV images (Canfield VISIA®) will be taken at baseline, EoT and FuV, accompanied by conventional dermatological assessment according to clinical routine.

Interventions

DRUGTirbanibulin

Klisyri® 10 mg/g Ointment (Tirbanibulin) patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Informed consent * Diagnosed with sun-damaged skin on the face and AK in the treatment area * Willing and able to comply with all study procedures * Use of medically acceptable contraception in males or females of child-bearing potential * 51 -100 years of age * Negative pregnancy test at baseline in females of childbearing potential

Exclusion criteria

* Allergy or intolerance towards the active ingredient or any of the constituents of the IMP * Any contraindication for the IMP, according to the most recent version of the SmPC * Open lesions of any kind on the face * Concomitant cutaneous malignancy in treatment area, including but not restricted to squamous skin cancer * Immune deficiency * Participation in another clinical trial during the last six months * Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame	Description
Unmasking of subclinical lesions in UV-exposed areas of chronically sun-damaged skin of the face by a treatment with Tirbanibulin.	57± 7 days	Total clearance rates of unmasked lesions 57± 7 days after the start of the treatment.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026