4-aminopyridine for Skin Wound Healing

ConditionsWounds Wound of Skin Wound Heal Wounds and Injuries

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorJohn Elfar

About this trial

Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults.

The purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing.

The investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Otherwise healthy adult patients without skin conditions effecting the skin of the axilla or upper inner arm.

Cognitive ability to evaluate wound healing, report sensory and motor deficit during examination.

Eligible for standard of care plan for wound closure by secondary intention (normal healing without intervention).

Adults subject aged 18-70

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

4-Aminopyridine
Drug
Active study drug
Placebo
Other intervention
Placebo comparator

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Group A: 4-aminopyridineActive comparator 1 intervention

Group B: Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Return of skin integrity and wound closure after skin punch biopsy

Axillary skin punch biopsies will be performed on healthy volunteers. Wound healing will be measured using visual assessment.

Time frame

6 weeks

Secondary outcomes

The effect of 4-AP on the hair number and growth at the skin punch biopsy site.

The axillary skin punch biopsies will evaluated for the number of hair follicles and hair growth.

Time frame

6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

John Elfar

Lead sponsor

University of Arizona

Sponsor institution

Source ClinicalTrials.gov

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