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The objective of this Trial is to evaluate the performance of RPh201 as a treatment for the healing of partial thickness burns. It is further postulated that deep second degree lesions will benefit from the RPh201 treatment promoting granulation and epithelialization as well as wound closure.
The objective of this Trial is to evaluate the performance of RPh201 in the treatment of partial thickness burns (second degree superficial and deep) of less than 5%TBSA.
The additional follow up for a period of 20 weeks will be scheduled to extend the evaluation of wounds of Subjects that completed up to 3 weeks of treatment
This is to include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPh201 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPh201, botanical drug product | Drug | topical |
|
| Measure | Description | Time Frame |
|---|---|---|
| determine the safety use of RPh201 administered topically three times a week during an overall treatment period of up to 3 weeks | Safety evaluation - To demonstrate safety of using RPh201 oil solution in terms of type and severity of adverse events Achievement of wound closure / epithelialization of more than 75% percent of wound area in up to 3 weeks treatment | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eyal Winkler, Dr. MD | Clinic of the The Burn Unit, The Department of Plastic & Reconstructive Surgery and Medical Research Infrastructure Development and Health Services Fund by Chaim Sheba Medical Center Tel Hashomer, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of the The Burn Unit, The Department of Plastic & Reconstructive Surgery and Medical Research Infrastructure Development and Health Services Fund by Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
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