Periorbital BurnsPhase 1NCT06362226
Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management
A Phase 1 study testing Steroid/Antibiotic (Maxitrol) and 5-FU/Kenalog in people with Periorbital Burns, run by Virginia Commonwealth University.
Trial summary
The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& topical Maxitrol Ophthalmic ointment as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periorbital Burns
- What is being tested?
- Steroid/Antibiotic (Maxitrol) and 5-FU/Kenalog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2026to 5 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Mechanism of Injury including explosion, thermal, electrical
- Clinical diagnosis of periorbital burn wound
- Second degree or less periorbital or lid bur
- No previous surgical treatment for wound management
- Partial Deep thickness Periorbital burn
Show all 9Show fewer
- Partial Thickness Burn
- Superficial Burn
- Periocular lesions with globe involvement
Who cannot join
- Recent surgical intervention for wound
- Full Thickness and or "Third degree Burns"
- Imprisoned Inmates
- Chemical Burn
- Pregnant women
- Individuals whom are not adults >18 years of age
About this study
The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& topical Maxitrol Ophthalmic ointment as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns.
- Conditions
- Periorbital Burns
- Being tested
- Steroid/Antibiotic (Maxitrol), 5-FU/Kenalog
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid/Antibiotic (Maxitrol)Drug
Group one subjects receive topical maxitrol ophthalmic ointment twice daily for two weeks
5-FU/KenalogDrug
Group two undergoes treatment with a subcutaneous injection of a 5-fluorouracil (5-FU) and Kenalog (triamcinolone) combination (80/20 ratio, 0.3-0.5 mL per session) administered in four sessions, spaced two weeks apart, starting within 48 hours of hospital presentation
| Study group | Role | What they receive |
|---|---|---|
| Group A: 5-FU/Kenalog | Experimental | Not described Receives: Drug: 5-FU/Kenalog |
| Group B: Steroid/Antibiotic | Experimental | Not described Receives: Drug: Steroid/Antibiotic (Maxitrol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of wound healing time
This outcome is comparing the would healing time between the 2 groups. A shorter would healing time would indicate faster recovery.
Measured: 12 months
Comparison of infection rate
This outcome is comparing the infection rate during treatment. A lower infection rate may indicate which treatment is superior to the other.
Measured: 12 months
Comparison of complication rates
Complication rate is assessed through the occurrence of adverse events. A lower complication rate could indicate improved safety and tolerability over one treatment.
Measured: 12 months
Secondary outcomes (4)
Comparison of pain level
This will be assessed through the standardized pain scale. The scale is from 1-5. 1 being no pain and 5 being excruciating pain. A lower pain score suggests better pain management due to improved healing.
Measured: 12 months
Comparison of quality of life
The use of the burns outcome questionnaire (BOQ) to assess the participant's quality of life throughout the study. This is a 17 question questionnaire with each question scale being from 0 to 4. 0 being not at all and 4 being very much. The scores are then added up for a total score. The range of total scores is from 0-68. A higher score may indicate improved well-being with a specific treatment.
Measured: 12 months
Comparison of cosmetic outcome through the Vancouver scar scale (VSS)
Variables in the VSS include pigmentation, vascularity, pliability and height. The range for the total score is 0-13. A lower VSS scores suggest better scar appearance as well as quality.
Measured: 12 months
Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS)
Variables in the POSAS include color, thickness, relief, pliability, surface area and overall opinion. The range for the total score is 11-44. Lower POSAS scores indicate improved scar aesthetics.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start5 Jun 2026
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Why it stopped: Inventory not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital BurnsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikisha Richards, MD, FACS, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362226
- Sponsor's protocol ID
- HM20029491
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management
- ClinicalTrials.gov ID
- NCT06362226
- Acronym / sponsor ID
- HM20029491
- Conditions
- Periorbital Burns
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inventory not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 12 Apr 2024 (actual)
- 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 purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& topical Maxitrol Ophthalmic ointment as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: 5-FU/Kenalog | Experimental | Drug: 5-FU/Kenalog |
| Group B: Steroid/Antibiotic | Experimental | Drug: Steroid/Antibiotic (Maxitrol) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Mechanism of Injury including explosion, thermal, electrical
- Clinical diagnosis of periorbital burn wound
- Second degree or less periorbital or lid bur
- No previous surgical treatment for wound management
Key exclusion criteria (6 listed)
- Recent surgical intervention for wound
- Full Thickness and or "Third degree Burns"
- Imprisoned Inmates
- Chemical Burn
- Pregnant women
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 |
|---|---|---|
| Steroid/Antibiotic (Maxitrol)Group one subjects receive topical maxitrol ophthalmic ointment twice daily for two weeks | Drug | Group B: Steroid/Antibiotic |
| 5-FU/KenalogGroup two undergoes treatment with a subcutaneous injection of a 5-fluorouracil (5-FU) and Kenalog (triamcinolone) combination (80/20 ratio, 0.3-0.5 mL per session) administered in four sessions, spaced two weeks apart, starting within 48 hours of hospital presentation | Drug | Group A: 5-FU/Kenalog |
Primary outcome
Comparison of wound healing time
Time frame: 12 months
This outcome is comparing the would healing time between the 2 groups. A shorter would healing time would indicate faster recovery.
Comparison of infection rate
Time frame: 12 months
This outcome is comparing the infection rate during treatment. A lower infection rate may indicate which treatment is superior to the other.
Comparison of complication rates
Time frame: 12 months
Complication rate is assessed through the occurrence of adverse events. A lower complication rate could indicate improved safety and tolerability over one treatment.
4 secondary outcomes
Comparison of pain level
Time frame: 12 months
Comparison of quality of life
Time frame: 12 months
Comparison of cosmetic outcome through the Vancouver scar scale (VSS)
Time frame: 12 months
Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS)
Time frame: 12 months
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 9 Jun 2026.
- Individual participant dataSharing planned: No
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.
Nikisha Richards, MD, FACS principal investigator
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Steroid/Antibiotic (Maxitrol) and 5-FU/Kenalog in people with Periorbital Burns, run by Virginia Commonwealth University.
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 9 inclusion and 6 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of wound healing time (time frame: 12 months). The study lists 3 primary outcomes in all. 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 9 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.