Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn

NCT01455480 | Withdrawn Phase 1

• 1 other identifier: RGN-BWH-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Second Degree Burn; partial thickness burns

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

RPh201

EXPERIMENTAL

Drug: RPh201, botanical drug product

Interventions

RPh201, botanical drug product DRUG

topical

RPh201

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regenera Pharma Ltd: lead

Study Sites (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, 52621, Israel

Location

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2011
• First Posted: October 20, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

IL (1)