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

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medizinische Universität Graz

Graz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirbanibulin

Drug

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

Primary outcomes

Unmasking of subclinical lesions in UV-exposed areas of chronically sun-damaged skin of the face by a treatment with Tirbanibulin.

Time frame: 57± 7 days

Total clearance rates of unmasked lesions 57± 7 days after the start of the treatment.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Acronym: SunDamage

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jun 12, 2023
Registry last updated: Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed