Not Yet RecruitingPhase 2ACTRN12612000142831

Clobetasol Propionate ointment application to grafted burn wound

A pilot randomised double blind, longitudinal placebo control trial to investigate the effects of Clobetasol Propionate ointment on skin grafts for burn wounds.


Sponsor

Burns Unit

Enrollment

30 participants

Start Date

Feb 10, 2012

Study Type

Interventional

Conditions

Summary

Burn injuries result in pain, inflammation and destruction of skin cells. Skin grafting will be required when the depth of the injury destroys the deeper skin layers. Despite grafting, the burn injury continues to produce inflammatory chemicals or mediators. These mediators result in a thickened and raised scar with increased sensitivity and itching. The purpose of this research is to see if Clobetasol propionate can reduce the inflammatory mediators thereby reducing active scar tissue formation.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether applying clobetasol propionate ointment (a strong steroid cream) to skin graft sites on burn wounds can improve healing outcomes. Adults aged 18 to 65 with full-thickness burns covering less than 25% of the body who received skin grafts may participate.

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

use of a super potent corticosteroid ointment (Clobetasol Propionate 0.05%) on grafted burn wounds. Clobetasol Propionate ointment applied as the treatment and a common moisturizing ointment as the c

use of a super potent corticosteroid ointment (Clobetasol Propionate 0.05%) on grafted burn wounds. Clobetasol Propionate ointment applied as the treatment and a common moisturizing ointment as the control. Dosage of treatment is half fingertip unit i.e.0.25g once daily for 8 weeks, self-administered by participants. Each patient acts as their own control, by applying the treatment or placebo to a randomized site 1 or 2(crossover). Participants being asked to wash their hands between application of the two ointments to avoid mixing the effect of the two ointments. The investigator will decide anatomical location of two comparable areas of 3cmx3cm that are accessible for self application of ointment and will mark them as site 1 and site 2. The jars marked A and B, will be prepared by company and the content is unknown to the investigator and the participant. The investigator then randomly allocate which jar on which site using procedure such as coin-tossing . Then the record for each participant will be made giving code number to the participant. (e.g. 001, jar A- site 1, jar B- site 2). There is no break in-between application of two ointments during the 8 weeks trial. The two ointments will be applied at the same time for 8 weeks on their allocated sites for comparison record.


Locations(1)

Australia

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ACTRN12612000142831