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

NCT05900258 | Completed Phase 4

• 1 other identifier: SunDamage
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Tirbanibulin

Interventions

Tirbanibulin DRUG

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

Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age
• Negative pregnancy test at baseline in females of childbearing potential

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medizinische Universität Graz

Graz, Austria

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

tirbanibulin

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 12, 2023
• Study Start: May 11, 2023
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)