RecruitingPhase 2ACTRN12624001365550

A study testing a gel containing 0.1% mometasone furoate, applied once a day, to see if it helps in the treatment of chronic leg wounds

Effect of once-daily topical 0.1%w/w mometasone furoate hydrogel on wound size and pro-inflammatory mediators in adults with chronic wounds: a single-blind, randomised, placebo-controlled pilot study.


Sponsor

Ego Pharmaceuticals

Enrollment

20 participants

Start Date

Mar 16, 2023

Study Type

Interventional

Conditions

Summary

A study to test the use of a hydrogel containing 0.1%w/w mometasone furoate applied once a day in the treatment of chronic leg wounds. Adults meeting the study entry criteria will be identified and randomised to apply either the active product or a placebo over a period of 28 days, with follow-up after an additional 7 days. Hypothesis: A hydrogel containing 0.1%w/w mometasone furoate will shorten the healing time of chronic leg wounds in adult patients, as measured by reduced wound size and reduced inflammatory mediators.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic leg wounds — wounds that have not healed within a month despite standard treatment — are a common and difficult problem, particularly in older adults. They can cause significant pain, limit mobility, and reduce quality of life. Inflammation is a key barrier to wound healing, and corticosteroid medications (which reduce inflammation) have been used to treat some skin conditions, but their use in wound healing has not been well studied. This study is testing a topical hydrogel containing a low dose of mometasone furoate (a mild corticosteroid) applied once daily to chronic lower leg wounds over 28 days. Participants are randomly assigned to either the active gel or a placebo gel and assessed over 5 weeks for wound size reduction, inflammatory markers, and adverse effects. You may be eligible if you are 18 or older, have a chronic lower leg wound that has not healed for at least one month despite conventional treatment, and are not taking other topical or systemic treatments that could interfere with results. People with pregnancy, diabetes, chronic kidney or liver disease, or known allergies to the product's ingredients are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

0.1% w/w mometasone furoate hydrogel applied once daily to the wound. Dosage – 1 fingertip unit (0.5g) per 2% body surface area equivalent Duration – 28 days, or until the wound has healed, whicheve

0.1% w/w mometasone furoate hydrogel applied once daily to the wound. Dosage – 1 fingertip unit (0.5g) per 2% body surface area equivalent Duration – 28 days, or until the wound has healed, whichever comes first Adherence monitoring – Tubes will be measured prior to commencing trial, and at each timepoint, including final visit, to determine how much product has been used


Locations(1)

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

VIC, Australia

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ACTRN12624001365550