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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

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.

Table of contents

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.[1]

The study is designed to evaluate efficacy, safety, and tolerability, with a focus on wound healing and local skin tolerance.[1]

Study design and phase

This is an interventional study, which means the researchers give a treatment and then measure the results.[1]

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.[1]

The trial compares the active gel with a vehicle, which is the same gel base without the active ingredient.[1]

Who can participate

The target population is people with epidermolysis bullosa, especially those with dystrophic epidermolysis bullosa or junctional epidermolysis bullosa.[1]

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.[1]

What is being measured

The main endpoint is the open index wound area up to Day 56 compared with the starting point.[1]

This means the study is checking whether the wound becomes smaller over time, which is a sign of healing.[1]

The brief summary also says the study will evaluate safety and tolerability, including local tolerability of the gel in patients with DEB or JEB.[1]

Trial status and size

The trial status is Authorised.[1]

The planned enrollment is 32 participants, so this is a small study.[1]

Patient-friendly terms

  • Randomized means people are placed into study groups by chance, which helps make the results fair.[1]

  • Double-blind means neither the participant nor the study team knows who gets which treatment during the study.[1]

  • Vehicle-controlled means the treatment is compared with the same gel base without the active ingredient.[1]

  • Wound healing means the wound is closing and getting smaller.[1]

  • Tolerability means how well people can use the treatment without local problems or discomfort.[1]

Trial ID Phase Condition studied Status Enrollment
2024-515172-12-00 Phase 2 Epidermolysis Bullosa Authorised 32

FAQ

  • What is being studied in these clinical trials? The trial is studying 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 as a topical treatment for wounds in epidermolysis bullosa. The main goals are to see if it helps wounds heal and if it is safe and well tolerated.
  • Who can take part in the study? The target population is patients with epidermolysis bullosa, especially those with dystrophic epidermolysis bullosa or junctional epidermolysis bullosa. The trial data do not give more detailed entry rules.
  • What phase is the trial? This is a Phase 2 study. Phase 2 trials usually look more closely at whether a treatment works and continue to check safety.
  • What condition is the trial focused on? The trial focuses on epidermolysis bullosa, a group of conditions that cause fragile skin and wounds. The summary specifically mentions dystrophic and junctional forms.
  • What is the main result being measured? The main result is the change in open index wound area up to Day 56 compared with the starting point. This helps show whether the wound is getting smaller over time.

Ongoing Clinical Trials on 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

  • Study on the Effects of TCP-25 Gel for Wound Healing in Patients with Epidermolysis Bullosa

    Recruiting

    1
    Investigated diseases:
    Investigated drugs:
    France Greece Italy Spain Sweden

Glossary

  • Epidermolysis bullosa (EB): A group of conditions where the skin is very fragile and can blister or break easily.
  • Dystrophic epidermolysis bullosa (DEB): A form of epidermolysis bullosa mentioned in the study population.
  • Junctional epidermolysis bullosa (JEB): Another form of epidermolysis bullosa mentioned in the study population.
  • Phase 2: A study stage that looks at whether a treatment may work and continues to monitor safety.
  • Randomized: People are assigned by chance to study groups, which helps make the comparison fair.
  • Double-blind: Neither the participants nor the study team know who gets which treatment during the trial.
  • Vehicle-controlled: The treatment is compared with a vehicle, which is the same gel or product base without the active ingredient.
  • Topical application: Placed directly on the skin or wound.
  • Open index wound area: The size of the wound that is still open. A smaller area may mean better healing.
  • Tolerability: How well people can use a treatment without troublesome effects or discomfort.

References

  1. https://clinicaltrials.gov/study/2024-515172-12-00