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

NCT ID: NCT05900258

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-11

Study Completion Date

2023-11-13

Brief Summary

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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.

Detailed Description

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Conditions

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Actinic Keratosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

Tirbanibulin

Intervention Type DRUG

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

Interventions

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Tirbanibulin

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medizinische Universität Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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SunDamage

Identifier Type: -

Identifier Source: org_study_id

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