4-Aminopyridine to help heal second-degree skin burns
4-Aminopyridine to Treat Skin Burns
This trial will try 4-aminopyridine in adults with recent second-degree burns to see if it speeds healing.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT06596434 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives adults with acute second-degree burns either 4-aminopyridine or a placebo and follows them through scheduled visits to measure healing and safety. Eligible burns must be at least 6 cm2 and treated within seven days of injury, with participants able to report sensory and motor changes. The investigational drug is given as an add-on to standard burn care so current infection control and fluid management continue. Primary outcomes focus on the speed and quality of wound closure and monitoring for any treatment-related adverse effects.
Who should consider this trial
Good fit: Adults aged 18–80 with acute second-degree burns of at least 6 cm2 occurring within the past 7 days who can consent and attend follow-up visits are ideal candidates.
Not a fit: People with full-thickness (third-degree) burns, chronic wounds, a history of seizure disorder, multiple sclerosis, significant renal impairment, or those outside the enrollment window or age range are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, patients could experience faster wound closure, fewer complications, and potentially reduced need for grafting or prolonged wound care.
How similar studies have performed: There is limited prior human burn-healing data for this approach; 4-aminopyridine has an established safety record in other conditions but little direct evidence yet for accelerating burn regeneration.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tucson, Arizona
- University of Arizona — Tucson, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: John Elfar, MD — University of Arizona
- Study coordinator: Carly J Deal, MPH
- Email: carlyjdeal@arizona.edu
- Phone: 520-626-1588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.