None listed
Conditions
Brief 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.
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, 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
Sponsors
Ego Pharmaceuticals
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Males or females aged 18 years and over. • Subjects possessing a chronic lower limb wound which has not healed for at least one month with conventional treatments. • Free of any dermatological or systemic disorder which could interfere with the results, at the discretion of the Investigator. • Completed a preliminary medical history form. • Have read, understood and signed an informed consent document relating to the specific type of study they are subscribing. • Able to cooperate with the Investigator and research staff, willing to have the test materials applied according to the protocol and complete the full course of the study.
Exclusion criteria
• Individuals under 18 years of age. Diabetes, severe cardiac, respiratory, gastrointestinal, liver, renal disease, malignancy, or any other medical condition that may interfere with wound healing, at the discretion of the Investigator. Complications of these medical conditions may preclude individuals who are not well to meet the study requirements and attendance to the clinic. • History of allergies or adverse reactions to the components of the specific products being tested. • Use of other topical therapies in the week prior to or during participation in this trial. • Individuals taking any medication (topical or systemic) such as antibiotics, NSAIDs, narcotics, corticosteroids, antineoplastics or immunosuppressants that may mask or interfere with the test results, at the discretion of the Investigator. • A history of any acute or chronic disease that may interfere with or increase the risk of study participation. • Excessive hair on the test sites. • Individuals diagnosed with chronic skin allergies. • Pregnant or nursing females.
Outcome results
None listed