Overview

Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn

Status:
Withdrawn
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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 from the RPh201 treatment promoting granulation and epithelialization as well as wound closure.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Regenera Pharma Ltd
Criteria
Inclusion Criteria:

1. The Subject is 18 years of age and older.

2. The Subject has at least one burn wound or more from 1%- 5% TBSA overall.

3. Subjects defined as a partial thickness burn for conservative treatment (second degree
superficial and deep).

4. 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.

5. The Subject is expected to be available for the 3 weeks Trial ambulatory treatment.

6. The Subject is willing and able to adhere to the protocol regimen.

7. The Subject is able to read, understand, and has signed the informed consent form.

Exclusion Criteria:

1. Electrical and chemical burns wounds that are third degree or full thickness.

2. Burn wounds of more than 48hours from burn event

3. 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.

4. 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.

5. Known history for allergy to cottonseed oil or mastic gum

6. 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.

7. Presence or suspicion of any malignancy.

8. Female Subjects who are pregnant or nursing, or of childbearing potential and are not
using adequate contraception.

9. Participation in another clinical trial within 30 days prior to the Screening Visit or
during this Trial.

10. Mentally disable Subjects

11. A tourist or foreigner or refugee that cannot be followed for the Trial period.