NCT06596434 4-Aminopyridine to Treat Skin Burns
| NCT ID | NCT06596434 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | John Elfar |
| Condition | Burns |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2026-01-01 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
Contact & Investigator
John Elfar, MD
PRINCIPAL INVESTIGATOR
University of Arizona
Frequently Asked Questions
Who can join the NCT06596434 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Burns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06596434 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06596434 currently recruiting?
Yes, NCT06596434 is actively recruiting participants. Contact the research team at carlyjdeal@arizona.edu for enrollment information.
Where is the NCT06596434 trial being conducted?
This trial is being conducted at Tucson, United States.
Who is sponsoring the NCT06596434 clinical trial?
NCT06596434 is sponsored by John Elfar. The principal investigator is John Elfar, MD at University of Arizona. The trial plans to enroll 200 participants.