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Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn

Primary Purpose

Second Degree Burn Less Than 5%TBSA, Partial Thickness Burn

Status

Withdrawn

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

RPh201, botanical drug product

About this trial

This is an interventional treatment trial for Second Degree Burn Less Than 5%TBSA focused on measuring Second Degree Burn, partial thickness burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RPh201

Arm Description

Outcomes

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01455480

First Posted

October 16, 2011

Last Updated

December 5, 2016

Sponsor

Regenera Pharma Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01455480

Brief Title

Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn

Official Title

Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Withdrawn

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regenera Pharma Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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 from the RPh201 treatment promoting granulation and epithelialization as well as wound closure.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Second Degree Burn Less Than 5%TBSA, Partial Thickness Burn

Keywords

Second Degree Burn, partial thickness burns

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RPh201

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

RPh201, botanical drug product

Intervention Description

topical

Primary Outcome Measure Information:

Title

determine the safety use of RPh201 administered topically three times a week during an overall treatment period of up to 3 weeks

Description

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eyal Winkler, Dr. MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

12. IPD Sharing Statement

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Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn

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