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It is the first clinical study aimed at assessing the safety and tolerability of HM242-Solution and HM242-Gel after their application under occlusion on intact skin. The HM242-Solution is intended for chronic wounds (e.g. pressure, venous leg and diabetic foot ulcers). The HM242-Solution should be used for physical rinsing and cleansing and subsequent decolonization of the wound prior to treatment with hydrogels and dressings. The HM242-Gel is a hydrogel for wound bed preparation to support the healing of the skin due to cleansing, moistening and subsequent decolonization and the coating of the wound.
The study will be conducted in outpatient manner, adult patients who are healthy and has an intact skin.
This is an prospective, open label, monocentric study. No comparative control group is planned as no other preventing infection solution is commercially available at this time.
The objective of this study is to assess the local tolerability and safety of HM242-Solution and HM242-Gel after their application under occlusion on intact skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | All patients will receive an occlusive patch per test treatment as follows:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM242 | Device | HM242-Solution and HM242-Gel will be topically applied in an occlusive patch for 48h on healthy skin on the subject's outer part of the upper arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of related Adverse Events from Study Start until the End of Study (EoS) | to assess safety of HM242-Solution and HM242-Gel in healthy subjects which will be assessed in terms of related adverse events occurrence during the study (as reported by subjects and/or observed by the investigator) | Day 1 to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Post treatment assessment (via patch test scoring system provided by International Contact Dermatitis Research Group) by the Investigator. Scoring system: "-" no reaction; "Ir" irritative reaction (vesicles, blister, necrosis) | to assess local tolerability of HM242-Solution and HM242-Gel in healthy subjects which will be assessed by the investigator using the patch test | Day 3, Day 4, Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Welf Prager, Dr. med | Dermatologische Praxis Prager & Partner | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologische Praxis Prager & Partner | Hamburg | 22609 | Germany |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 14, 2021 | |
| Reset | Feb 2, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 14, 2021 | Feb 2, 2021 |
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