Table of Contents
- Trial overview
- Who can participate
- What is being tested
- Study phase and size
- Endpoints and measurements
- What the trial means for patients
Trial overview
This clinical trial is studying TUVATEXIB as an ointment for people with actinic keratosis, a skin condition linked to sun damage.[1]
The study is interventional, which means researchers give a treatment and compare the results between study groups.[1]
The trial status is Authorised, and the planned enrollment is 39 participants.[1]
Who can participate
The trial is for patients with actinic keratosis.[1]
Each participant must have a marker lesion, which is the skin lesion chosen for close follow-up in the study.[1]
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.[1]
What is being tested
Researchers are comparing TUVATEXIB ointment with a placebo ointment.[1]
A placebo looks like the study treatment but does not contain the active study drug, so the comparison can be made more fairly.[1]
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.[1]
Study phase and size
This is a Phase 2 trial.[1]
Phase 2 studies usually look more closely at whether a treatment may work in a patient group, after earlier testing has already been done.[1]
The study plans to include 39 people, which makes it a small, focused clinical trial.[1]
Endpoints and measurements
The main primary endpoint is the modified PRO score of the marker lesion after 12 weeks of treatment.[1]
A primary endpoint is the main result the trial is designed to measure.[1]
The lesion is assessed with LC-OCT, a skin imaging method that shows skin layers in detail.[1]
The marker lesion is defined before treatment starts as the actinic keratosis lesion with the highest basal proliferation score, as measured by LC-OCT.[1]
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.[1]
The study focuses on one lesion rather than all skin spots, which helps researchers measure change in a clear way.[1]
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.[1]
