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Triamcinolone

Clinical trials investigating Triamcinolone are studying its role in ulcerative pyoderma gangrenosum, a painful skin condition with ulcers. These trials look at treatment effects and safety in adult patients, often in comparison with placebo or other medicines. The goal is to see how well the study treatment helps ulcers close completely.

Table of Contents

Trial overview

The trial data includes one study that lists Triamcinolone among the medicines used in a Phase 3 trial for ulcerative pyoderma gangrenosum.[1] The study was completed and enrolled 149 participants.[1]

The trial title describes it as a randomized, double-blind, placebo-controlled, multicenter, and adaptive study.[1] These words describe how the trial was run, not the disease itself.

Study design and phase

This was an interventional study, which means researchers gave study treatments and then measured the results.[1] It was a Phase 3 study, which is usually done in a larger group of patients to test how well a treatment works and to keep checking safety.[1]

Randomized means patients were assigned by chance to different study groups.[1] Double-blind means the patient and the study team did not know which treatment was given, which helps reduce bias, meaning unfair influence on the results.[1]

Placebo-controlled means some patients received a placebo, which looks like the study treatment but has no active medicine.[1] Multicenter means the trial took place at more than one study site.[1]

Adaptive means the study design could allow planned changes during the trial based on the data collected.[1]

Who participated

The trial focused on patients with ulcerative pyoderma gangrenosum.[1] This is a painful skin condition that causes ulcers, or open sores, and the study aimed to test treatment effects in this group.[1]

The source data does not give more details about age limits, sex, or other entry rules.[1] It only states the condition studied and the total number of enrolled participants.[1]

What was measured

The main outcome was the proportion of patients achieving complete closure of the target ulcer by the end of treatment visit.[1] This means the researchers counted how many patients had full healing of the main ulcer.

Complete closure was defined as complete re-epithelization, meaning the wound was covered by a skin layer or scar, with no drainage and no need for a dressing.[1] The result had to be confirmed at two study visits that were 2 weeks apart.[1]

Treatments listed in the trial

The trial data lists several medicines and a placebo option, including Triamcinolone.[1] Other listed treatments were prednisolone, cortisone acetate, fludrocortisone, prednisone, dexamethasone, hydrocortisone, methylprednisolone, betamethasone, and an intravenous placebo for the study drug Gohibic.[1]

The source does not explain which of these were given to each patient in the Triamcinolone-related part of the trial or how the groups were assigned beyond the randomized, placebo-controlled design.[1]

What the trial setup means for patients

For patients, this trial was mainly about whether treatment could help the ulcer close fully and stay closed long enough to be confirmed at two visits.[1] That kind of outcome matters because full closure can mean the sore is healing in a meaningful and lasting way.

Because the study was Phase 3 and placebo-controlled, it was designed to give stronger evidence about how well the treatment strategy works in this condition.[1] The completed status and enrollment number show that the study has finished collecting data.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05964413 Phase 3 Ulcerative pyoderma gangrenosum Completed 149

FAQ

  • What condition is being studied in the Triamcinolone trial data? The trial data focuses on ulcerative pyoderma gangrenosum, a skin condition that causes painful ulcers. The main goal is to see whether the study treatment helps the target ulcer close completely.
  • What phase is the Triamcinolone-related trial? The trial listed in the data is a Phase 3 study. Phase 3 trials usually test how well a treatment works in a larger group of patients and continue to check safety.
  • Who can take part in these trials? The trial is for patients with ulcerative pyoderma gangrenosum. The source data does not give more details about exact age limits or other entry rules.
  • What is the main result the trial is measuring? The main result is complete closure of the target ulcer. This means the ulcer is fully covered by new skin or a scar, with no drainage and no need for a dressing, confirmed at two visits 2 weeks apart.
  • Is Triamcinolone the only treatment being studied? No. The trial data lists Triamcinolone among several treatments and placebo options used in the study. The overall trial is designed to compare treatment effects in patients with the condition.

Ongoing Clinical Trials on Triamcinolone

  • Study on Vilobelimab and Drug Combination for Treating Ulcerative Pyoderma Gangrenosum in Adults

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Italy The Netherlands +2

Glossary

  • Ulcerative pyoderma gangrenosum: A rare skin disease that can cause painful, open sores or ulcers. The trial is studying treatments for this condition.
  • Phase 3: A later stage of clinical research that usually includes more patients. It helps show whether a treatment works well and continues to monitor safety.
  • Randomized: Patients are placed into treatment groups by chance, not by choice. This helps make the results fair.
  • Double-blind: Neither the patient nor the study team knows who gets which treatment. This helps reduce bias, which means less chance of unfair results.
  • Placebo: A treatment that looks like the real study treatment but has no active medicine. It is used for comparison.
  • Multicenter: The study is run at more than one hospital or clinic. This can make the results more reliable.
  • Adaptive trial: A study design that can allow planned changes while the trial is still running, based on the data collected.
  • Interventional study: A trial where researchers give a treatment and then measure the effects.
  • Primary outcome: The main result the researchers want to measure. In this trial, it is whether the target ulcer closes completely.
  • Complete re-epithelization: A medical way to say the wound is fully covered by new skin.
  • Target ulcer: The main ulcer chosen for close study during the trial.

References