Clinical trial · Interventional
Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tirbanibulin | Drug | Tirbanibulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- interventionNames
- Drug: Tirbanibulin
Primary outcomes (1)
- measure
- Unmasking of subclinical lesions in UV-exposed areas of chronically sun-damaged skin of the face by a treatment with Tirbanibulin.
- timeFrame
- 57± 7 days
- description
- Total clearance rates of unmasked lesions 57± 7 days after the start of the treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available