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Search / Trial NCT06651476

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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Oct 17, 2024

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

Healthy Volunteer Uvb Burn Burn Pain

ClinConnect Summary

This clinical trial is looking at whether a hormone called oxytocin can help increase pain tolerance when combined with vibration therapy in people who have mild sunburns. The researchers want to see if these treatments can make it easier to handle heat pain in the sunburned area of the skin.

To participate in this study, you need to be between 18 and 55 years old, in generally good health, and have light to medium skin tones (Fitzpatrick Scale ratings I to III). Unfortunately, if you have a history of skin cancer or certain medical conditions, such as chronic pain or certain heart issues, you would not be eligible to join. If you qualify, you will receive treatments and be monitored by the research team to see how your body responds. This study is currently recruiting participants, and it aims to find new ways to help people manage pain from sunburn.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male or female \> 18 and ≤55 years of age, Body Mass Index (BMI) \<40
  • Generally in good health as determined by the Principal Investigator based on prior medical history, and as assessed to be American Society of Anesthesiologists physical status 1, 2, or 3
  • Fitzpatrick Scale rating I through III
  • Exclusion Criteria:
  • History of skin cancer
  • Dark enough skin complexion that would make it infeasible to determine the minimal erythematous dose of UV-B irradiation. Anyone Fitzpatrick Scale score \>3 will be excluded
  • 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
  • Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval
  • Subjects with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, SSRI's, MAOI, or the recreational drug ecstasy
  • Subjects with a known latex allergy

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

James C Eisenach, M.D.

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported