In short
Clinical trials investigating TUVATEXIB are studying an ointment in people with actinic keratosis, a sun-related skin condition. The trial is looking at how well it works compared with placebo and measuring results with skin imaging after 12 weeks.
Key points
- TUVATEXIB is being studied in a Phase 2 clinical trial for people with actinic keratosis. The study compares TUVATEXIB ointment with placebo ointment. Researchers are focusing on one marker lesion on the head or face for each participant. The main goal is to see change in the modified PRO score after 12 weeks, using LC-OCT skin imaging. The trial plans to enroll 39 people and is currently authorised.
Trial overview
This clinical trial is studying TUVATEXIB as an ointment for people with actinic keratosis, a skin condition linked to sun damage.
The study is interventional, which means researchers give a treatment and compare the results between study groups.
The trial status is Authorised, and the planned enrollment is 39 participants.
Who can participate
The trial is for patients with actinic keratosis.
Each participant must have a marker lesion, which is the skin lesion chosen for close follow-up in the study.
In this trial, the marker lesion is the actinic keratosis lesion with the highest starting score, and it must be on the head or face.
What is being tested
Researchers are comparing TUVATEXIB ointment with a placebo ointment.
A placebo looks like the study treatment but does not contain the active study drug, so the comparison can be made more fairly.
The brief study summary says the goal is to evaluate the efficacy, meaning how well the treatment works, on the marker lesion after 12 weeks.
Study phase and size
This is a Phase 2 trial.
Phase 2 studies usually look more closely at whether a treatment may work in a patient group, after earlier testing has already been done.
The study plans to include 39 people, which makes it a small, focused clinical trial.
Endpoints and measurements
The main primary endpoint is the modified PRO score of the marker lesion after 12 weeks of treatment.
A primary endpoint is the main result the trial is designed to measure.
The lesion is assessed with LC-OCT, a skin imaging method that shows skin layers in detail.
The marker lesion is defined before treatment starts as the actinic keratosis lesion with the highest basal proliferation score, as measured by LC-OCT.
What the trial means for patients
This trial is designed to learn whether TUVATEXIB ointment can improve a selected actinic keratosis lesion better than placebo.
The study focuses on one lesion rather than all skin spots, which helps researchers measure change in a clear way.
Because the trial is authorised and in Phase 2, it is part of the clinical research process that checks whether the treatment should be studied further.