|Age:||7 to 85 years old|
|Keywords:||Toxic Epidermal Necrolysis, TEN, Stevens-Johnson’s Syndrome|
|Type:||Drug study, Phase [1, 2]|
Since there are diseases that look similar, an initial biopsy will be taken to determine if you or your child qualify for this study. This is routine standard of care.
The study doctor will randomly assign small areas (less than 3% of total body surface area) of affected skin to receive either clobetasol 0.05% ointment or petrolatum ointment. This randomization will be done by coin toss. The treatment you get on each designated area will be chosen by chance. Neither you nor the study doctor will choose what treatment to get on each treatment area.
The amount of clobetasol ointment that will be applied is based on your/your child’s body surface area. Following application of the ointments, the treated skin will be dressed with proper wound care gauze dressings. The treatment will be applied once daily for up to 14 days.
As a measure of safety, each treatment area will receive a numeric score. The study team will monitor for redness, swelling and other signs of cellulitis (local infection). Your treated areas of skin will be evaluated daily. If one of your treated areas appears at least 30% worse than the other, study personnel will evaluate for possible local infection. They may possibly stop application of ointment to that area if indicated. The areas of treated skin will be photographed daily in a way that does not disclose your identity. This will help the researchers track the appearance of the skin during the study.
Study personnel will assess if the study ointments are having any effect on your/your child’s skin through daily examinations. Both arms will be photographed daily before application of ointments.
On day three of therapy, two small 4 mm punch biopsies will be obtained, one from each treated area of skin.
These biopsy samples are collected by numbing up your skin with an injectable numbing medication (anesthetic). Then, by use of a circular punch tool, a small piece of skin will be removed and analyzed in the researcher’s laboratory. The wound will be stitched closed with dissolvable material that does not need to be removed. These biopsy specimens will be used for research purposes to determine the genetics of your/your child’s disease. Following the final application of ointment, a post-treatment evaluation will be conducted. For patients that complete all 14 days of treatment, this final evaluation will occur on day 15.
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.