A Randomized Controlled Trial to Test the Effects Oxytocin and Vibration Have on Heat Pain Threshold After UV-B Burn

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

It had two arms (groups): oxytocin (experimental) and placebo (placebo comparator).

Two 30 minute infusions of placebo separated by 30 minutes. The first infusion will consist of two steps, using an equivalent volume of placebo fluid infusion as in the oxytocin arm. This will consist of a slower rate in the first 5 minutes and more rapid rate for the last 25 min. The second placebo solution infusion will be a constant rate and volume equivalent to that used in the oxytocin arm.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female \> 18 and ≤55 years of age, Body Mass Index (BMI) \<40. Fitzpatrick Scale rating I through III.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: history of skin cancer; neuropathy, chronic pain (located in any body location that is being treated), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis; pregnancy or currently breast feeding.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2024-12-05 with completion listed for 2025-11-20.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Difference between heat pain threshold (time frame: 24 hours after UV-B exposure).

It also tracked 3 secondary outcomes, for example Difference between heat pain threshold, Touch and pain threshold to von Frey filament application and Touch and pain threshold to von Frey filament application.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 38 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.