Status:
WITHDRAWN
Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn
Lead Sponsor:
Regenera Pharma Ltd
Conditions:
Second Degree Burn Less Than 5%TBSA
Partial Thickness Burn
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 fr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- The Subject is 18 years of age and older.
- The Subject has at least one burn wound or more from 1%- 5% TBSA overall.
- Subjects defined as a partial thickness burn for conservative treatment (second degree superficial and deep).
- Subjects will be eligible to participate in the Trial if their target lesion area of the edges is not more than 500-750 cm2 at baseline.
- The Subject is expected to be available for the 3 weeks Trial ambulatory treatment.
- The Subject is willing and able to adhere to the protocol regimen.
- The Subject is able to read, understand, and has signed the informed consent form.
Exclusion
- Electrical and chemical burns wounds that are third degree or full thickness.
- Burn wounds of more than 48hours from burn event
- Presence of a systemic infection or significant local infection such as cellulites, purulent drainage, gangrene, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement.
- Previous history of any illness or condition that may impair wound healing, immune deficiency or connective tissue disease (e.g., SLE, AIDS), neurological disease (e.g., multiple sclerosis), dialysis due to renal disease and active hepatic disease.
- Known history for allergy to cottonseed oil or mastic gum
- Subject is receiving, or has received within one month prior to Visit 1 any treatment known to impair wound healing, including but not limited to: corticosteroids, immuno-suppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
- Presence or suspicion of any malignancy.
- Female Subjects who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
- Participation in another clinical trial within 30 days prior to the Screening Visit or during this Trial.
- Mentally disable Subjects
- A tourist or foreigner or refugee that cannot be followed for the Trial period.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01455480
Start Date
December 1 2011
End Date
December 1 2011
Last Update
December 6 2016
Active Locations (1)
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1
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, Israel, 52621