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

Actinic Keratosis Clinical Trial

— SunDamage  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05900258
• Other study ID #: SunDamage
• Status: Completed
• Phase: Phase 4
• Start date: May 11, 2023
• Est. completion date: November 13, 2023

Study information

• Verified date: November 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 13, 2023
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

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

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

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