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

Medical University of Graz

Status and phase

Completed

Phase 4

Conditions

Actinic Keratosis

Treatments

Drug: Tirbanibulin

Study type

Interventional

Funder types

Other

Identifiers

NCT05900258

SunDamage

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Volunteers

No 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