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

• Sponsor: Medical University of Graz (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05900258
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.7
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratosis	Drug: Tirbanibulin	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face
• Actual Study Start Date: May 11, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment	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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medizinische Universität Graz	Graz		Austria

Sponsors and Collaborators

• Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT05900258
• Other Study ID Numbers: SunDamage
• First Posted: Jun 12, 2023
• Last Update Posted: Jun 12, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Keratosis, Actinic; Keratosis; Tirbanibulin

Study Results

No Results Posted as of Jun 12, 2023