Topical Amitriptyline for Burn Injury

PT
Overseen ByPharmacology Translational Unit
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called amitriptyline to determine its effectiveness in treating skin damage from small burns. Researchers aim to discover if applying the cream immediately after a burn can block certain skin particles involved in healing. They will compare different application times to assess any differences. Individuals with a small burn who can consent to skin testing might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that topical amitriptyline is usually safe for use. Studies have found that applying small amounts to wounds does not interfere with healing. Some users report mild skin irritation, such as redness or itching, at the application site. However, these side effects are generally minor. Importantly, topical amitriptyline does not appear to cause the more serious side effects associated with its oral form, making it a promising option for treating skin injuries like burns.12345

Why do researchers think this study treatment might be promising for burn injury?

Unlike the standard treatments for burn injuries, which often involve pain relief medications and topical antibiotics, the study treatment, topical amitriptyline, uses a different approach by targeting nerve pain directly at the site of the burn. Amitriptyline is traditionally used as an oral antidepressant, but its topical application aims to provide localized pain relief without systemic side effects. Researchers are excited because this method may offer faster and potentially more effective pain management right at the source, offering a new avenue for treating burn pain that doesn't rely on systemic painkillers.

What evidence suggests that topical amitriptyline might be an effective treatment for burn injury?

Research suggests that topical amitriptyline, a cream applied to the skin, might aid burn recovery by reducing harmful particles released after a burn. In one study, 55% of patients using this cream experienced a noticeable decrease in pain. Some studies indicate it may not be effective for nerve-related pain on uninjured skin, but others show it can help certain conditions. Although consistent evidence is lacking, early results are promising for its use in burn recovery. Participants in this trial will receive topical amitriptyline after a burn is induced with a heated metal bar, while others will receive a placebo for comparison.23467

Are You a Good Fit for This Trial?

This trial is for adults who are able to undergo a small, controlled skin burn and skin biopsy. Participants should be generally healthy with no major medical conditions that would make the procedure unsafe.

Inclusion Criteria

Must be able to give informed consent
All skin types on Fitzpatrick Scale (Type I-VI)
I am between 18 and 64 years old.
See 1 more

Exclusion Criteria

I am currently taking medications that increase sensitivity to light or affect inflammation.
Large tattoos in designated testing areas
History of abnormal scarring (i.e., keloids) or poor wound healing
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a thermal burn injury followed by application of 10% amitriptyline or placebo at various time intervals

2 hours
1 visit (in-person)

Follow-up

Participants are monitored for MVP levels in skin biopsies after treatment

2 hours
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Amitriptyline

Trial Overview

The study compares applying amitriptyline cream versus a placebo cream to small burn injuries on the skin. Researchers want to see if amitriptyline can reduce certain particles (MVPs) released after burns. Skin samples will be taken for analysis.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Heated Metal Bar to SkinExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wright State University

Lead Sponsor

Trials
47
Recruited
55,300+

Citations

Effectiveness and Tolerability of Topical Amitriptyline 10 ...

Twenty-two of 40 patients (55%; 95% CI, 40–69) achieved a ≥ 50% reduction in pain intensity, and 27 of 40 (68%; 95% CI, 52–80) achieved a ≥ 30 ...

Amitriptyline for Thermal Burns · Info for Participants

Research has shown that amitriptyline might aid recovery by reducing tiny particles released from the skin after a burn. These particles can be harmful,

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26059975/

Systematic review of topical amitriptyline for the treatment ...

Controlled clinical trials reveal that topical amitriptyline is not effective in treating neuropathic pain. The uncontrolled clinical trials did support ...

Safety Evaluation of Topically Applied Amitriptyline in ...

The high serum level of amitriptyline and nortriptyline did not affect wound healing; Amitriptyline at the concentrations of 0.0625% has no overt toxic effect ...

Compounded Topical Pain Creams: Review of Select ...

There is limited and inconsistent evidence to suggest that topical amitriptyline is not effective to treat neuropathic pain when applied to intact skin.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/17961834/

Safety evaluation of topically applied amitriptyline in ...

In this report we investigated the effect of amitriptyline on porcine full thickness wounds resembling excised burn wounds. We assessed if daily topical ...

Analgesic Effects of Topical Amitriptyline in Patients With ...

Topical 10% amitriptyline may provide effective pain relief in CIPN patients. No systemic adverse events typically associated with oral amitriptyline or local ...