← Back to Search

Hormone Therapy

Lotion for Sleep

N/A

Waitlist Available

Led By Lisa E Olson, Ph.D.

Research Sponsored by University of Redlands

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from immediately prior to administration to 48 hours post administration

Awards & highlights

Study Summary

This trial will compare how quickly melatonin from lotions and bubble baths is absorbed compared to oral tablets, and how long it stays in the body.

Who is the study for?

This trial is for University of Redlands students who are interested in how melatonin, a sleep-promoting hormone, works when taken in different forms. It's not suitable for those with allergies to scented lotions or bath products, or for pregnant individuals.Check my eligibility

What is being tested?

Researchers are testing the absorption and duration of melatonin in the body when administered as an oral tablet, lotion, and bubble bath to compare which method is most effective at delivering the hormone.See study design

What are the potential side effects?

Melatonin typically has mild side effects that can include drowsiness during waking hours, slight changes in blood pressure, vivid dreams or morning grogginess. The study will monitor if these vary by application method.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from immediately prior to administration to 48 hours post administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from immediately prior to administration to 48 hours post administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and from immediately prior to administration to 48 hours post administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Salivary melatonin level

Secondary outcome measures

Side effects

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373

42%

Fatigue

39%

Early Morning Wakening

36%

Daytime drowsiness

11%

Weakness

11%

Dizziness

11%

Nausea

11%

Blurred vision

100%

80%

60%

40%

20%

Study treatment Arm

Melatonin

Placebo

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: LotionExperimental Treatment1 Intervention

Dr. Teal's Sleep Lotion with Melatonin, Lavender, and Chamomile. 3 g lotion applied to one arm (without washing for at least 4 hours).

Group II: Bubble bathExperimental Treatment1 Intervention

Dr. Teal's Sleep Bath with Melatonin, Lavender, and Chamomile. 40L warm tap water maintained between 36.5 - 40 degrees C (98 - 104 degrees F) and 2 ml bubble bath. Participants will soak their feet and legs in the cooler for 15 minutes and then dry off (without rinsing or washing for at least 4 hours).

Group III: Oral tabletActive Control1 Intervention

3 mg Tablets (Nature Made). Participants will need to fast for 2 hours prior to consumption and 2 hours after consumption.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin

2014

Completed Phase 4

~1150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of RedlandsLead Sponsor

2 Previous Clinical Trials

83 Total Patients Enrolled

1 Trials studying Sleep

63 Patients Enrolled for Sleep

Lisa E Olson, Ph.D.Principal InvestigatorUniversity of Redlands

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 65 and above eligible to participate in this clinical trial?

"To qualify for enrollment, participants must be aged between 18 and 22 years old."

Answered by AI

Which specific individuals would be more suitable candidates for enrollment in this clinical trial?

"Eligible participants for this study must be within the age range of 18 to 22 and have regular sleep patterns. The trial aims to enroll approximately 10 individuals."

Answered by AI

Is the enrollment for this study currently open?

"As per clinicaltrials.gov, this particular research is presently not in pursuit of additional participants. Originally listed on May 10th, 2024, the last update occurred on April 19th, 2024. Despite its closure for enrollment, there are currently ongoing recruitment efforts for 145 other investigations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations

2024. "Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06382610.

All > Melatonin