The tested medical device is indicated for the treatment of wounds and small skin injuries. The intention of this study is to evaluate the tolerance and efficacy of the test product by measuring the recovery of the skin barrier after wound produced by suction blister. But also, by validating the accompanying physiological effect of the study product during this recovery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
44
For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model.
* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) * For subsequent visits, before product application
* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) * For subsequent visits, before product application
Dr. Kirstin Deuble-Bente
Schenefeld, Germany
Effect of the tested product on the wound healing at D6
By measuring the wound surface (measured by macro-photos) on treated area compared to an untreated area
Time frame: Day6
Effect of the tested product on the cutaneous barrier restoration
By measuring the TEWL (Trans Epidermal Water Loss) on treated area compared to an untreated area
Time frame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Effect of the tested product on healing
By measuring the wound surface (measured by macro-photos) on treated area compared to an untreated area
Time frame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Tolerance of the tested product
By measuring the occurence of adverse event
Time frame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Twice daily application on superficial wounds