NCT05900258CompletedPhase 4
Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face
Source: ClinicalTrials.gov · Last updated 14 Nov 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 10 May 2023
- Start date
- 11 May 2023
- Primary completion date
- 13 Nov 2023
- Lead sponsor
- Medical University of Graz
- NCT number
- NCT05900258
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 22
- From 11 May 2023 to the primary completion date, 13 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant cutaneous malignancy in treatment area, including but not restricted to squamous skin cancer
Other illness
- Allergy or intolerance towards the active ingredient or any of the constituents of the IMP
Other
- Any contraindication for the IMP, according to the most recent version of the SmPC
- Open lesions of any kind on the face
- Immune deficiency
- Participation in another clinical trial during the last six months
- Pregnancy or lactation
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universität Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.