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

Primary Purpose

Actinic Keratosis

Status
Recruiting
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Tirbanibulin
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Universität GrazRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2023
Last Updated
June 7, 2023
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT05900258
Brief Title
Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face
Acronym
SunDamage
Official Title
Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tirbanibulin
Intervention Description
Klisyri® 10 mg/g Ointment (Tirbanibulin) patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC.
Primary Outcome Measure Information:
Title
Unmasking of subclinical lesions in UV-exposed areas of chronically sun-damaged skin of the face by a treatment with Tirbanibulin.
Description
Total clearance rates of unmasked lesions 57± 7 days after the start of the treatment.
Time Frame
57± 7 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daisy Kopera, Prof. Dr.
Phone
+43316385
Ext
2423
Email
daisy.kopera@medunigraz.at
Facility Information:
Facility Name
Medizinische Universität Graz
City
Graz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daisy Kopera

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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