BurnsPhase 2NCT06596434
4-Aminopyridine to Treat Skin Burns
A Phase 2 study testing Drug: 4-Aminopyridine in people with Burns and Second Degree Burn, run by John Elfar at 1 site in United States.
Trial summary
Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin. There is a need to develop treatments to accelerate and improve healing of burn injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Second Degree Burn, Wounds and Injuries
- What is being tested?
- Drug: 4-Aminopyridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Injured (burned) adults with a maximum severity of second-degree burns.
- Burns involving at least 6cm2 of skin area
- Acute burns within 7 days of injury
- Cognitive ability to evaluate burn healing, report sensory and motor deficit during examination.
- Adults aged 18-80
- Ability to give written informed consent.
- Capable of safely coming in for follow up visits on all scheduled appointments.
Who cannot join
- History of multiple sclerosis, stroke or any other diagnosed neurological disorder
- History of hypersensitivity to AMPYRA® or 4-aminopyridine
- Current use of aminopyridine medications, including other compounded 4-AP
- Suspected renal impairment based on the Choyke questionnaire.
- History of difficult compliance with timely follow up
- Patients outside the age range
Show all 15Show fewer
- Unable to provide informed consent.
- Patients with a known history of a seizure disorder (4-AP overdose can, in selected cases, result in limited seizure activity).
- Patients with a concomitant traumatic brain injury.
- Patients unable to communicate.
- Patients unwilling to complete the study requirements.
- Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, e.g. Cimetidine.
- Pregnancy, breastfeeding or incarcerated individuals.
- Non-English speaking
- Patients unable or unwilling to take calibrated (with gauge) photographs of their wounds
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Carly J Deal, 520-626-1588, carlyjdeal@arizona.edu
Veronica Rangel, BS, 5206164024, vrangel@arizona.edu
About this study
Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin. There is a need to develop treatments to accelerate and improve healing of burn injuries. More research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational treatment will be used to test the hypothesis that 4-AP accelerates burn healing in traumatically burned patients.
Read the detailed description
Burn treatment has not appreciably changed in decades. Most treatments focus on infection prevention and control, as well as fluid management. This is because burns are universally infected with bacteria allowed to infiltrate deeper tissues by the absence of a skin barrier. If bacteria can now get into these tissues, the problem is only made worse by the large amount of hydration that now can get out into the environment from the open wound. Desiccation sets in with deeper tissues losing fluids. This renders tissue significantly more susceptible to further infection, as dry tissues are less perfused and less capable of fighting infectious insults. Desiccation also robs burned patients of fluids vital to sustain cardiopulmonary function. Without skin, patients essentially lose fluids and cannot perfuse even the most vital organs with time.
Research in the field focuses on preventing complications and temporizing these two factors. No regenerative treatments are currently offered to accelerate wound healing, and few investigative treatments are ready for translation to human trials. Most of the pipelines for future treatment involve long development timelines and still focus chiefly on infection control instead of driving tissue to regenerate and heal faster. A significant gap is the need for a regenerative burn treatment that can be trialed while still allowing the use of current protocols. An adjuvant regenerative burn treatment is needed.
The purpose of this study is to evaluate the role of local 4-aminopyridine (4-AP) on the treatment of burn wounds to accelerate healing.
- Conditions
- Burns, Second Degree Burn, Wounds and Injuries
- Being tested
- Drug: 4-Aminopyridine, Placebo
- Keywords
- 4-aminopyridine, 4-AP, Burns, Second degree burn, Wounds
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: 4-AminopyridineDrug
Also called 4AP, 4-AP, Dalfampridine
Active study drug
PlaceboOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Group A: 4-aminopyridine | Active comparator | Dalfampridine (generic) 10 mg capsule PO every 12 hours Receives: Drug: Drug: 4-Aminopyridine |
| Group B: Placebo | Placebo comparator | Placebo - 1 capsule PO every 12 hours Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate
Each subject will undergo detailed fiducial-marking augmented macroscopic imaging to determine baseline burn area measurement. These measurements will be repeated at each follow up study visit to assess healing rate.
Measured: 12 months
Secondary outcomes (3)
Skin-graft rate
Skin-graft rate (failure of healing)
Measured: 12 months
Scar formation
Scar formation will be measured by the Patient and Observer Scar Assessment Scale (POSAS). Each item of the POSAS is rated on a 10-point score with total scores ranging from 6 to 60 with higher scores indicating increase severity of symptoms. These measurements will be repeated at each follow up study visit.
Measured: 12 months
Scar sensitivity
Scar sensitivity will be measured by the Patient and Observer Scar Assessment Scale (POSAS). Each item of the POSAS is rated on a 10-point score with total scores ranging from 6 to 60 with higher scores indicating increase severity of symptoms. These measurements will be repeated at each follow up study visit to assess healing rate.
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 posted19 Sep 2024
- Study start1 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, randomized, placebo-controlled trial design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Elfar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Elfar, University of Arizona
- Investigators
- John Elfar, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596434
- Sponsor's protocol ID
- 00005193
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4-Aminopyridine to Treat Skin Burns
- ClinicalTrials.gov ID
- NCT06596434
- Acronym / sponsor ID
- 00005193
- Conditions
- Burns, Second Degree Burn, Wounds and Injuries
- Keywords
- 4-aminopyridine, 4-AP, Burns, Second degree burn, Wounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- John ElfarUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 19 Sep 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.
Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin. There is a need to develop treatments to accelerate and improve healing of burn injuries. More research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational treatment will be used to test the hypothesis that 4-AP accelerates burn healing in traumatically burned patients.
Detailed description
Burn treatment has not appreciably changed in decades. Most treatments focus on infection prevention and control, as well as fluid management. This is because burns are universally infected with bacteria allowed to infiltrate deeper tissues by the absence of a skin barrier. If bacteria can now get into these tissues, the problem is only made worse by the large amount of hydration that now can get out into the environment from the open wound. Desiccation sets in with deeper tissues losing fluids. This renders tissue significantly more susceptible to further infection, as dry tissues are less perfused and less capable of fighting infectious insults. Desiccation also robs burned patients of fluids vital to sustain cardiopulmonary function. Without skin, patients essentially lose fluids and cannot perfuse even the most vital organs with time.
Research in the field focuses on preventing complications and temporizing these two factors. No regenerative treatments are currently offered to accelerate wound healing, and few investigative treatments are ready for translation to human trials. Most of the pipelines for future treatment involve long development timelines and still focus chiefly on infection control instead of driving tissue to regenerate and heal faster. A significant gap is the need for a regenerative burn treatment that can be trialed while still allowing the use of current protocols. An adjuvant regenerative burn treatment is needed.
The purpose of this study is to evaluate the role of local 4-aminopyridine (4-AP) on the treatment of burn wounds to accelerate healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind, randomized, placebo-controlled trial design.
| Arm | Type | Receives |
|---|---|---|
| Group A: 4-aminopyridine | Active comparator | Drug: Drug: 4-AminopyridineDalfampridine (generic) 10 mg capsule PO every 12 hours |
| Group B: Placebo | Placebo comparator | Other: PlaceboPlacebo - 1 capsule PO every 12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Injured (burned) adults with a maximum severity of second-degree burns.
- Burns involving at least 6cm2 of skin area
- Acute burns within 7 days of injury
- Cognitive ability to evaluate burn healing, report sensory and motor deficit during examination.
- Adults aged 18-80
Key exclusion criteria (15 listed)
- History of multiple sclerosis, stroke or any other diagnosed neurological disorder
- History of hypersensitivity to AMPYRA® or 4-aminopyridine
- Current use of aminopyridine medications, including other compounded 4-AP
- Suspected renal impairment based on the Choyke questionnaire.
- History of difficult compliance with timely follow up
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 |
|---|---|---|
| Drug: 4-AminopyridineAlso: 4AP, 4-AP, DalfampridineActive study drug | Drug | Group A: 4-aminopyridine |
| PlaceboPlacebo comparator | Other | Group B: Placebo |
Primary outcome
Healing rate
Time frame: 12 months
Each subject will undergo detailed fiducial-marking augmented macroscopic imaging to determine baseline burn area measurement. These measurements will be repeated at each follow up study visit to assess healing rate.
3 secondary outcomes
Skin-graft rate
Time frame: 12 months
Scar formation
Time frame: 12 months
Scar sensitivity
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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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.
John Elfar, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug: 4-Aminopyridine in people with Burns and Second Degree Burn, run by John Elfar at 1 site in United States.
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 15 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carly J Deal, MPH (520-626-1588, carlyjdeal@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate (time frame: 12 months). 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 5 Mar 2026.