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

• Status: Recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Tirbanibulin

Criteria

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