NCT06651476

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

A Randomized Controlled Trial to Test Whether Oxytocin Amplifies the Effect of Vibration to Increase Heat Pain Threshold After UV-B Burn

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to answer the question: Does oxytocin increase the pain threshold on thermal heat pain in the presence of vibration on an area of skin exposed to a mild sunburn?

Detailed description

The goal of this clinical trial is to test whether intravenous oxytocin increases the analgesic effect of vibration on heat pain threshold of skin that has been exposed to Ultraviolet-B (UV-B) burn (mild sunburn). Researchers will compare oxytocin (a hormone that naturally occurs in the body) to a placebo (a look-alike substance that contains no drug) to see if oxytocin works to increase the pain threshold (the lowest intensity at which one begins to perceive or sense a stimulus as being painful).

Conditions

• Sunburn

Interventions

Type	Name	Description
DRUG	oxytocin	Oxytocin 10 IU will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion.
DRUG	placebo	A placebo will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion.

Timeline

• Start date: 2024-12-05
• Primary completion: 2025-11-20
• Completion: 2025-11-20
• First posted: 2024-10-21
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study