BurnPhase 1NCT00734695
Comparing the Use of Vitamin c (Ascorbic Acid) in Eye Burn in Subconjunctival Injection to Topical or Oral Treatment.
A Phase 1 study testing vitamin c in people with Burn, run by The Baruch Padeh Medical Center, Poriya at 2 sites in Israel.
Trial summary
Eye burns may cause a severe permanent damage. One kind of treatment is the use of vitamin C (Ascorbic acid). This study will compare between subconjunctival topical and/or systemic route of administration and topical and/or systemic administration. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Burn
- What is being tested?
- vitamin c
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2009to Feb 2010
- Phase
- Phase 1
- 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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eyes clinic patients presented with acute chemical or thermal burn.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Effect of Subconjunctival Vitamin c on Recovery Rate and End Result From Eye Burn.
Eye burns may cause a severe permanent damage. One kind of treatment is the use of vitamin C (Ascorbic acid). This study will compare between subconjunctival topical and/or systemic route of administration and topical and/or systemic administration.
Read the detailed description
In order to prevent permanent and severe damage to the eye after eye burn early treatment is mandatory. It is well known and published that the use of Vitamin c may contribute to the healing process of such burns, including burns from chemicals or heat. We believe that the route pf administration of the medicine is as important as the kind of medicine and that subconjunctival injection will have better effect and will influence in a favorable manner on the the end result as well as on the time of the healing.
In order to be able to compare between cases we made a new definition of the severity of the burn according to the extension of the damage on the cornea, conjunctiva and limbus, and according to the severity and depth of the ischemia.
In 3 medical centers 3 protocols of treatment and followup will be compared while only in Baruch Pade Medical Center the main route of administration will be subconjunctival on top of the topical treatment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin cDietary supplement
Also called subconjunctival, ascorbic acid
Subconjunctival daily or bid
vitamin cDietary supplement
Also called Burn, eye, ascorbic acid
topical and systemic
vitamin cDietary supplement
Also called burn
topical systemic
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Baruch Pade Medical Center Receives: Dietary Supplement: vitamin c |
| 2 | Active comparator | Rambam Medical Center Receives: Dietary Supplement: vitamin c |
| 3 | Active comparator | Soroka Medical Center Receives: Dietary Supplement: vitamin c |
What is being measured
The primary outcome is the main question the study is designed to answer.
EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA
Measured: BID
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startJul 2009
- Primary completionNov 2009 (estimated)
- Study completionFeb 2010 (estimated)
Why it stopped: couldn't recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Collaborators
- Rambam Health Care Campus, Soroka University Medical Center
- Investigators
- naftali modi, MD, Principal investigator, Baruch Pade medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734695
- Sponsor's protocol ID
- vitcbrn.CTIL
- Status last verified
- Feb 2010
- First submitted
- 13 Aug 2008
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subconjunctival Vitamin c on Recovery Rate and End Result From Eye Burn.
- ClinicalTrials.gov ID
- NCT00734695
- Acronym / sponsor ID
- vitcbrn.CTIL
- Conditions
- Burn
- Keywords
- BURN, EYE, VITAMIN C, ASCORBIC ACID
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: couldn't recruit patients
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Collaborators
- Rambam Health Care Campus, Soroka University Medical Center
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 14 Aug 2008 (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.
Eye burns may cause a severe permanent damage. One kind of treatment is the use of vitamin C (Ascorbic acid). This study will compare between subconjunctival topical and/or systemic route of administration and topical and/or systemic administration.
Detailed description
In order to prevent permanent and severe damage to the eye after eye burn early treatment is mandatory. It is well known and published that the use of Vitamin c may contribute to the healing process of such burns, including burns from chemicals or heat. We believe that the route pf administration of the medicine is as important as the kind of medicine and that subconjunctival injection will have better effect and will influence in a favorable manner on the the end result as well as on the time of the healing.
In order to be able to compare between cases we made a new definition of the severity of the burn according to the extension of the damage on the cornea, conjunctiva and limbus, and according to the severity and depth of the ischemia.
In 3 medical centers 3 protocols of treatment and followup will be compared while only in Baruch Pade Medical Center the main route of administration will be subconjunctival on top of the topical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: vitamin cBaruch Pade Medical Center |
| 2 | Active comparator | Dietary Supplement: vitamin cRambam Medical Center |
| 3 | Active comparator | Dietary Supplement: vitamin cSoroka Medical Center |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eyes clinic patients presented with acute chemical or thermal burn.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| vitamin cAlso: subconjunctival, ascorbic acidSubconjunctival daily or bid | Dietary supplement | 1 |
| vitamin cAlso: Burn, eye, ascorbic acidtopical and systemic | Dietary supplement | 2 |
| vitamin cAlso: burntopical systemic | Dietary supplement | 3 |
Primary outcome
EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA
Time frame: BID
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 2 Mar 2010.
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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.
naftali modi, MD principal investigator
Baruch Pade medical center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vitamin c in people with Burn, run by The Baruch Padeh Medical Center, Poriya at 2 sites 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 1 inclusion and 0 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 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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.
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?
EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA (time frame: BID). 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 2 Mar 2010.