NCT06596434

4-Aminopyridine to Treat Skin Burns

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: John Elfar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Drug: 4-Aminopyridine	Active study drug
OTHER	Placebo	Placebo comparator

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-06-01
• Completion: 2028-09-01
• First posted: 2024-09-19
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study