Second Degree Burn Less Than 5%TBSAPhase 1/2NCT01455480
Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn
A Phase 1/2 study testing RPh201, botanical drug product in people with Second Degree Burn Less Than 5%TBSA and Partial Thickness Burn, run by Regenera Pharma Ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Second Degree Burn Less Than 5%TBSA, Partial Thickness Burn
- What is being tested?
- RPh201, botanical drug product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2011to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
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, 52621
About this study
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.
Read the 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.
- Being tested
- RPh201, botanical drug product
- Keywords
- Second Degree Burn, partial thickness burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPh201, botanical drug productDrug
topical
| Study group | Role | What they receive |
|---|---|---|
| RPh201 | Experimental | Not described Receives: Drug: RPh201, botanical drug product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Degree Burn Less Than 5%TBSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenera Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eyal Winkler, Dr. MD, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455480
- Sponsor's protocol ID
- RGN-BWH-001
- Status last verified
- Dec 2016
- First submitted
- 16 Oct 2011
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn
- ClinicalTrials.gov ID
- NCT01455480
- Acronym / sponsor ID
- RGN-BWH-001
- Keywords
- Second Degree Burn, partial thickness burns
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regenera Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RPh201 | Experimental | Drug: RPh201, botanical drug product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPh201, botanical drug producttopical | Drug | RPh201 |
Primary outcome
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Winkler, Dr. MD principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RPh201, botanical drug product in people with Second Degree Burn Less Than 5%TBSA and Partial Thickness Burn, run by Regenera Pharma Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.