Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Regenera Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01455480
First received: October 16, 2011
Last updated: January 23, 2014
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Second Degree Burn Less Than 5%TBSA
Partial Thickness Burn
Drug: RPh201, botanical drug product
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn

Resource links provided by NLM:


Further study details as provided by Regenera Pharma Ltd:

Primary Outcome Measures:
  • determine the safety use of RPh201 administered topically three times a week during an overall treatment period of up to 3 weeks [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    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


Enrollment: 0
Study Start Date: December 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RPh201 Drug: RPh201, botanical drug product
topical

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 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:

  • Efficacy assessment of burn improvement following the use of RPh2O1 oil solution administered topically three times per week during an overall treatment period of up to 3 weeks and at the follow-up visit at 20 weeks after end of treatment in Subjects with partial thickness burns (second degree superficial and deep) of less than 5%TBSA
  • Safety evaluation of RPh201 formulated as an oil solution administered topically three times per week during an overall treatment period of up to 3 weeks in Subjects with partial thickness burns (second degree superficial and deep) of less than 5%TBSA.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455480

Locations
Israel
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, 52621
Sponsors and Collaborators
Regenera Pharma Ltd
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Regenera Pharma Ltd
ClinicalTrials.gov Identifier: NCT01455480     History of Changes
Other Study ID Numbers: RGN-BWH-001
Study First Received: October 16, 2011
Last Updated: January 23, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Regenera Pharma Ltd:
Second Degree Burn
partial thickness burns

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on August 19, 2014