SunburnPhase 2NCT06651476
A Randomized Controlled Trial to Test the Effects Oxytocin and Vibration Have on Heat Pain Threshold After UV-B Burn
A Phase 2 study testing oxytocin in people with Sunburn, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunburn
- What is being tested?
- oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 20 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized Controlled Trial to Test Whether Oxytocin Amplifies the Effect of Vibration to Increase Heat Pain Threshold After UV-B Burn
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?
Read the 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
Oxytocin 10 IU will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion.
placeboDrug
A placebo will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion.
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | Two 30 minute infusions of oxytocin, 10 International Units (IU) separated by 30 minutes. To avoid potential unmasking by facial flushing which can occur at the beginning of high rates of oxytocin administration, the first infusion will consist of two steps beginning with a rate of 0.125 IU oxytocin per minute for 5 minutes, then increased to 0.375 IU oxytocin for 25 minutes. The second infusion will be a constant rate of 0.333 IU oxytocin per minute for 30 minutes. Receives: Drug: oxytocin |
| 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between heat pain threshold
Difference between heat pain threshold at 24 hours after Ultraviolet-B (UV-B) exposure at 3x minimum erythematous dose. The difference between the average threshold for stimuli #5-8 and the average threshold for stimuli #13-17 at baseline and 2 hours after the beginning of the oxytocin or placebo infusion will be used. The values are measured in degrees Celsius. A lower temperature indicates more sensitivity to heat pain.
Measured: 24 hours after UV-B exposure
Secondary outcomes (3)
Difference between heat pain threshold
Difference between heat pain threshold at 24 hours after UV-B exposure at 3x minimum erythematous dose. The difference between the average threshold for stimuli #5-8 and the average threshold for stimuli #13-17 at baseline and 2 days after the beginning of the oxytocin or placebo infusion will be used. The values are measured in degrees Celsius. A lower temperature indicates more sensitivity to heat pain.
Measured: Two days after UV-B exposure
Touch and pain threshold to von Frey filament application
Using an electronic von Frey instrument, threshold for touch and a prickly pain sensation will be determined at the site of UV-B exposure at 3x minimum erythematous dose and in normal skin to estimate the threshold for touch and prickly pain sensation. The measure will be recorded in grams. A lower pressure indicates more sensitivity to touch and pain.
Measured: 24 hours after UV-B exposure
Touch and pain threshold to von Frey filament application
Using an electronic von Frey instrument, threshold for touch and a prickly pain sensation will be determined at the site of UV-B exposure at 3x minimum erythematous dose and in normal skin to estimate the threshold for touch and prickly pain sensation. The measure will be recorded in grams. A lower pressure indicates more sensitivity to touch and pain.
Measured: Two days after UV-B exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start5 Dec 2024
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SunburnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- James C Eisenach, M.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651476
- Sponsor's protocol ID
- IRB00120861
- Other IDs
- 5P01NS119159
- Status last verified
- Nov 2025
- First submitted
- 17 Oct 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Test Whether Oxytocin Amplifies the Effect of Vibration to Increase Heat Pain Threshold After UV-B Burn
- ClinicalTrials.gov ID
- NCT06651476
- Acronym / sponsor ID
- IRB00120861
- Conditions
- Sunburn
- Keywords
- healthy volunteer, UVB burn, burn pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Drug: oxytocinTwo 30 minute infusions of oxytocin, 10 International Units (IU) separated by 30 minutes. To avoid potential unmasking by facial flushing which can occur at the beginning of high rates of oxytocin administration, the first infusion will consist of two steps beginning with a rate of 0.125 IU oxytocin per minute for 5 minutes, then increased to 0.375 IU oxytocin for 25 minutes. The second infusion will be a constant rate of 0.333 IU oxytocin per minute for 30 minutes. |
| placebo | Placebo comparator | Drug: placeboTwo 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxytocinOxytocin 10 IU will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion. | Drug | oxytocin |
| placeboA placebo will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion. | Drug | placebo |
Primary outcome
Difference between heat pain threshold
Time frame: 24 hours after UV-B exposure
Difference between heat pain threshold at 24 hours after Ultraviolet-B (UV-B) exposure at 3x minimum erythematous dose. The difference between the average threshold for stimuli #5-8 and the average threshold for stimuli #13-17 at baseline and 2 hours after the beginning of the oxytocin or placebo infusion will be used. The values are measured in degrees Celsius. A lower temperature indicates more sensitivity to heat pain.
3 secondary outcomes
Difference between heat pain threshold
Time frame: Two days after UV-B exposure
Touch and pain threshold to von Frey filament application
Time frame: 24 hours after UV-B exposure
Touch and pain threshold to von Frey filament application
Time frame: Two days after UV-B exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Sunburn
Not yet recruiting
Randomized Trial of a Sun Safety Intervention for Young Adults
Sunburn
Active, not recruitingPhase 3
Undergraduate Skin Cancer Prevention Trial
Skin Cancer
Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Eisenach, M.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxytocin in people with Sunburn, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between heat pain threshold (time frame: 24 hours after UV-B exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.