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Hormone Therapy

Oxytocin for Sunburn Pain

Phase 2

Waitlist Available

Led By James C Eisenach, M.D.

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female aged over 18 and up to 55 years, with a Body Mass Index (BMI) less than 40

Be between 18 and 65 years old

Must not have

Neuropathy, chronic pain (located in any body location that is being treated), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis

Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two days after uv-b exposure

Summary

This trial aims to find out if oxytocin can increase the pain threshold when applied to a sunburned area of skin exposed to heat and vibration.

Who is the study for?

This trial is for men and women aged 18-55, with a BMI under 40, in good health as per the Principal Investigator's assessment. Participants should have light to medium skin tone (Fitzpatrick Scale I-III). Excluded are those with dark complexions, pregnant or breastfeeding individuals, latex allergy sufferers, history of skin cancer or chronic pain conditions like neuropathy or diabetes, certain heart conditions, hyponatremia risk factors or on specific medications.

What is being tested?

The study investigates if oxytocin can increase the threshold for feeling heat pain after a mild sunburn when combined with vibration therapy. It compares the effects of oxytocin against a placebo in this setting.

What are the potential side effects?

While not explicitly stated here, common side effects of oxytocin may include emotional changes such as increased trust and bonding feelings; physical reactions might involve nausea or headache. Vibration therapy could cause discomfort at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old with a BMI under 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have neuropathy, chronic pain, diabetes, or take daily pain or anxiety medication.

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I have a history of heart rhythm problems.

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I have had skin cancer in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two days after uv-b exposure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two days after uv-b exposure

This trial's timeline: 3 weeks for screening, Varies for treatment, and two days after uv-b exposure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Difference between heat pain threshold

Touch and pain threshold to von Frey filament application

Side effects data

From 2014 Phase 1 & 2 trial • 18 Patients • NCT02205034

50%

Pyrexia

17%

Pneumopathy

17%

Rash maculopapular

17%

Lung infection

17%

Teething

17%

constipation

17%

Nasopharyngitis

17%

Hepatocellular injury

17%

Gastro-oesophageal reflux disease

100%

80%

60%

40%

20%

Study treatment Arm

First Arm

Second Arm

Third Arm

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: oxytocinExperimental Treatment1 Intervention

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.

Group II: placeboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

oxytocin

2019

Completed Phase 4

~2890

0 / 4Eligibility criteria met