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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05900258
Other study ID # SunDamage
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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