In short
Clinical trials are investigating H-GLY-LYS-TYR-GLY-PHE-TYR-THR-HIS-VAL-PHE-ARG-LEU-LYS-LYS-TRP-ILE-GLN-LYS-VAL-ILE-ASP-GLN-PHE-GLY-GLU-OH in people with epidermolysis bullosa. The study aims to assess efficacy, safety, and tolerability, especially wound healing and local skin tolerance. The target population includes patients with dystrophic or junctional epidermolysis bullosa.
Key points
- Clinical trials are investigating H-GLY-LYS-TYR-GLY-PHE-TYR-THR-HIS-VAL-PHE-ARG-LEU-LYS-LYS-TRP-ILE-GLN-LYS-VAL-ILE-ASP-GLN-PHE-GLY-GLU-OH in people with epidermolysis bullosa. The study is a Phase 2, randomized, double-blind, vehicle-controlled trial. It focuses on patients with dystrophic or junctional epidermolysis bullosa. The main goal is to see whether the treatment improves wound healing by reducing open wound area over 56 days. The trial also checks safety, tolerability, and local skin tolerance.
Trial overview
The available study is a randomized, double-blind, vehicle-controlled Phase 2 trial of H-GLY-LYS-TYR-GLY-PHE-TYR-THR-HIS-VAL-PHE-ARG-LEU-LYS-LYS-TRP-ILE-GLN-LYS-VAL-ILE-ASP-GLN-PHE-GLY-GLU-OH in patients with epidermolysis bullosa.
The study is designed to evaluate efficacy, safety, and tolerability, with a focus on wound healing and local skin tolerance.
Study design and phase
This is an interventional study, which means the researchers give a treatment and then measure the results.
Phase 2 studies are usually done after early safety work and are meant to learn more about whether a treatment may help the target condition.
The trial compares the active gel with a vehicle, which is the same gel base without the active ingredient.
Who can participate
The target population is people with epidermolysis bullosa, especially those with dystrophic epidermolysis bullosa or junctional epidermolysis bullosa.
The trial data provided here do not list more detailed entry rules, so the full inclusion and exclusion criteria are not available in this source.
What is being measured
The main endpoint is the open index wound area up to Day 56 compared with the starting point.
This means the study is checking whether the wound becomes smaller over time, which is a sign of healing.
The brief summary also says the study will evaluate safety and tolerability, including local tolerability of the gel in patients with DEB or JEB.
Trial status and size
The trial status is Authorised.
The planned enrollment is 32 participants, so this is a small study.
Patient-friendly terms
- Randomized means people are placed into study groups by chance, which helps make the results fair.
- Double-blind means neither the participant nor the study team knows who gets which treatment during the study.
- Vehicle-controlled means the treatment is compared with the same gel base without the active ingredient.
- Wound healing means the wound is closing and getting smaller.
- Tolerability means how well people can use the treatment without local problems or discomfort.