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

Phase 4

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Tirbanibulin

• Registration Number: NCT05900258
• Lead Sponsor: Medical University of Graz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-10
• Study Start: 2023-05-11
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-12
• Status Verified: 2023-11
• Primary Completion: 2023-11-13
• Study Completion: 2023-11-13
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Tirbanibulin	-

Primary Outcome Measures

Name	Time	Method
Unmasking of subclinical lesions in UV-exposed areas of chronically sun-damaged skin of the face by a treatment with Tirbanibulin.	57± 7 days	Total clearance rates of unmasked lesions 57± 7 days after the start of the treatment.

Trial Locations

Locations (1)

Medizinische Universität Graz; 🇦🇹 Graz, Austria