Oxytocin for Sunburn Pain
Recruiting in Palo Alto (17 mi)
Overseen byJames C Eisenach, M.D.
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Wake Forest University Health Sciences
Must not be taking: Benzodiazepines, Pain medications, SSRIs, MAOIs
Disqualifiers: Skin cancer, Diabetes, Hyponatremia, others
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?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?
Will I have to stop taking my current medications?
If you are taking benzodiazepines, pain medications daily, or any of the listed medications like thiazide diuretics, lithium, or SSRIs, you may need to stop as these are part of the exclusion criteria. The trial does not specify a washout period, but you should discuss with the trial team to understand any necessary changes to your medication.
Is oxytocin safe for use in humans?
Oxytocin, also known as Syntocinon, has been used safely in thousands of patients for various medical purposes, with no significant side effects reported. Studies show it does not cause genetic damage and has a safety profile similar to other standard treatments.
12345How does the drug oxytocin differ from other treatments for sunburn pain?
Oxytocin is unique for sunburn pain because it has antioxidant properties, which may help reduce inflammation and damage caused by oxidative stress, unlike typical sunburn treatments that mainly focus on soothing the skin or reducing pain.
678910Eligibility Criteria
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.Inclusion Criteria
I am between 18 and 55 years old with a BMI under 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
Dark enough skin complexion that would make it infeasible to determine the minimal erythematous dose of UV-B irradiation. Anyone Fitzpatrick Scale score greater than 3 will be excluded
Pregnancy or currently breast feeding
Subjects with a known latex allergy
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive two 30-minute infusions of oxytocin or placebo, separated by 30 minutes, to test the effect on heat pain threshold after UV-B burn
1 day
1 visit (in-person)
Follow-up
Participants are monitored for changes in heat pain threshold and touch/pain sensitivity using von Frey filament application
2 days
1 visit (in-person)
Participant Groups
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.
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.
Oxytocin is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Pitocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇪🇺 Approved in European Union as Syntocinon for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇨🇦 Approved in Canada as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇦🇺 Approved in Australia as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Atrium Health Wake Forest Baptist Medical CenterWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
Synthetic oxytocin. [2018]A synthetic oxytocin, Syntocinon(R), was used in 3,342 obstetrical patients for a wide variety of indications. It was concluded that the preparation is as effective as natural oxytocin.(1) There were no side effects observed, particularly vasospasm or anaphylactic reaction. Its use in clinical obstetrics can be recommended provided there is a proper indication for its use and the need for close supervision and individual adjustment of dosage is recognized.
In vitro cytogenetic analysis of the effects of oxytocin on human peripheral blood lymphocytes. [2019]The purpose of this study was to determine possible genotoxic and cytotoxic (or mitogenic) effects of high concentrations of oxytocin, active component of Syntocinon in cultures of human peripheral blood lymphocytes. Two test systems were used: (1) analysis of numerical and structural chromosome aberrations, and (2) the in vitro sister chromatid exchange (SCE) test. On the basis of the results obtained it can be concluded that oxytocin does not express any genotoxical properties. Furthermore, the mitotic index did not change significantly.
Variations in oxytocin regimes in Scottish labour wards in 1998. [2004]Oxytocin (Syntocinon, Sandoz Pharmaceuticals) is a commonly used drug in the modern management of labour. A recently published British survey found that 38% of low risk primigravid labours were augmented, most commonly by intravenous syntocinon. Unfortunately the misuse of syntocinon can lead to potentially serious problems for the fetus and mother. Despite the frequency of usage there appears to be no consensus as to the optimal dose and mode of administration. This paper explores the extent of this variation among Scottish obstetric units, the reasons for any variation in its use and makes some suggestions as to the way forward based on the current literature.
A randomised trial of carbetocin versus syntometrine in the management of the third stage of labour. [2021]Syntometrine is an effective uterotonic agent used in preventing primary postpartum haemorrhage but has adverse effects including nausea, vomiting, hypertension and coronary artery spasm. Carbetocin is a newly developed long-acting oxytocin analogue that might be used as an uterotonic agent. We compare the efficacy and safety of intramuscular (IM) carbetocin with IM syntometrine in preventing primary postpartum haemorrhage.
Carbetocin for the prevention of postpartum hemorrhage: a systematic review. [2018]The objective of this review was to evaluate the efficacy and safety of carbetocin in the prevention of postpartum hemorrhage. All trials found during a targeted Medline and Cochrane database search were screened for eligibility. Outcome measures were estimated blood loss, uterine tone, amount and type of lochia, fundal position after delivery (number of centimeters above or below the umbilicus), side-effects, adverse effects, vital signs, levels of hemoglobin/hematocrit before delivery compared with 24 or 48 hours postpartum, the need for additional uterotonic therapy, and/or uterine massage and duration of the third stage of labor. The retrieved studies were difficult to compare because of differences in study design and outcome. We conclude that carbetocin probably is as effective as oxytocin or syntometrine in the prophylactic management of the third stage of labor. Also carbetocin has a similar safety profile to oxytocin, which is now used as a standard prophylactic treatment. However, more research on this subject is needed.
Oxytocin ameliorates cisplatin-induced nephrotoxicity in Wistar rats. [2021]The clinical use of cisplatin (CP) is highly limited because of its renal toxicity and the production of reactive oxygen species (ROS) that intensify the cytotoxic effects. Oxytocin (OT) was previously shown to have antioxidant activity.
Oxytocin alleviates cisplatin-induced renal damage in rats. [2022]The purpose of the present study was to investigate the protective effect of oxytocin on cisplatin (CP)-induced renal damage in rats.
Oxytocin inhibits NADPH oxidase and P38 MAPK in cisplatin-induced nephrotoxicity. [2017]Oxidative stress significantly contributes to cisplatin (CP)-associated cytotoxicity, and use of antioxidants could counteract such cytotoxic effects of CP. The major biochemical pathway for reactive oxygen species (ROS) formation proceeds through O₂⁻ production, which is generated by NADPH oxidase, such oxidative stress can activate p38 MAPK to intensify the cytotoxic effect of CP. We mainly aimed to study the protective effect of oxytocin (OT) on CP-induced nephrotoxicity whereas; it was previously shown to have anti-inflammatory effects in different inflammation models. Administration of OT significantly decreased the gene expression of both NADPH oxidase and P38 MAPK, nitric oxide (NO), myloperoxidase (MPO), and TBARS, furthermore it increased the renal tissue levels of antioxidants; reduced glutathione (GSH), and superoxide dismutase (SOD). Histologically, OT reduced the monocellular infiltration as well as the tubular damage in CP-induced nephrotoxicity. In conclusion OT has a powerful antioxidant effect that can alleviate the CP-induced nephrotoxicity through inhibition of NADPH oxidase and P38 MAPK resulting in improvement of kidney functions.
Phase I studies of nogitecan hydrochloride for Japanese. [2013]SmithKline Beecham synthesized camptothecin analogs and identified nogitecan hydrochloride (topotecan) with a broad spectrum of antitumor activity and less toxicity than camptothecin. Because preclinical and overseas clinical data indicated the antitumor effect of nogitecan hydrochloride with a 5-day repeat-dose schedule, we carried out phase I studies in Japan to determine the maximum tolerated dose (MTD), pharmacokinetics, and antitumor effect of nogitecan hydrochloride.
Water soluble 20(S)-glycinate esters of 10,11-methylenedioxycamptothecins are highly active against human breast cancer xenografts. [2018]Water-soluble 20(S)-glycinate esters of two highly potent 10,11-methylenedioxy analogues of camptothecin (CPT) have been synthesized and evaluated for their ability to eradicate human breast cancer tumor xenografts. The glycinate ester moiety increases the water solubility of the 10,11-methylenedioxy analogues 4-16-fold. However, in contrast to CPT-11, a water-soluble CPT analogue that was recently approved for second line treatment of colorectal cancer, the 20(S)-glycinate esters do not require carboxylesterase for conversion to their active forms. The glycinate esters are hydrolyzed to their parent, free 20(S)-hydroxyl active analogues in phosphate buffer (pH 7.5) and in mouse and human plasma. The glycinate esters are also 20-40-fold less potent than CPT-11 in inhibiting human acetylcholinesterase. In vivo, we examined 20(S)-glycinate-10,11-methylenedioxycamptothecin, 20(S)-glycinate-7-chloromethyl-10,11-methylenedioxycamptothecin, and CPT-11. We found that the two 10,11-methylenedioxy analogues had antitumor activity against breast cancer xenografts that was comparable to that of CPT-11. Our results indicate that water-soluble 20(S)-glycinate esters of highly potent CPT analogues provide compounds that maintain biological activity, do not require interactions with carboxylesterases, and do not inhibit human acetylcholinesterase.