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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy adult subjects | Experimental | It's a randomized intra-individual comparative study with two injured study areas (treated and untreated) for each subject. The randomization will determine the application side on which the tested product will be applied (RIGHT or LEFT forearm). Twice daily application on the treated area. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction of suction blister | Procedure | For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1) |
| Effect of the tested product on healing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirstin Deuble-Bente, Dr. | Kiebitzweg 2, 22869 Schenefeld/Hamburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Kirstin Deuble-Bente | Schenefeld | 22869 | Germany |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Transepidermal water loss (TEWL) | Other |
|
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| Macrophotography | Other |
|
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| Wound healing medical device | Device | Twice daily application on superficial wounds |
|
By measuring the wound surface (measured by macro-photos) on treated area compared to an untreated area |
| Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1) |
| Tolerance of the tested product | By measuring the occurence of adverse event | Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1) |