SleepNCT06382610
Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations
A study testing Melatonin in people with Sleep, run by University of Redlands at 1 site in United States.
Trial summary
Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2024to 31 Jul 2026
- Phase
- Interventional
- 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 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- University of Redlands student
Who cannot join
- Allergies or sensitivities to scented lotions or bath products
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body.
Read the detailed description
Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. A previous study (unpublished) has shown that a small amount of an over-the-counter lotion increases salivary melatonin levels by up to 1000 fold, a startling amount. Researchers will characterize the time course of the absorption and metabolism of lotion- and bubble bath-based melatonin compared to oral tablets in healthy 18-21 year olds.
The peak level, time to peak level and half-life of melatonin will be compared between the administration routes using a within-person (repeated measures) design and saliva sampling over 48 hours. Participants can choose specific days to participate within a one-month window, with a maximum of four sampling periods. All participants will collect control saliva samples (no melatonin treatment) one night at 10 PM and 4 AM. Participants will be asked to have two treatments 1) oral melatonin and 2) either lotion melatonin or bubble-bath melatonin. Participants can indicate if they have a preference for lotion vs. bubble bath or if they are willing to undergo both lotion and bubble bath treatments (adding a fourth sampling period). Order will be randomized.
For the treatments, saliva sampling times are as follows: Prior to melatonin administration (10 AM), then 15 min, 30 min, 45 min, 60 min, 90 min, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours (10 PM), 18 hours (4 AM), 24 hours, 36 hours, and 48 hours after administration. Samples will be frozen at the participant's home until returned to the researchers at a later date. Melatonin in saliva samples will be quantitated via Enzyme Linked Immunosorbent Assay.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Melatonin will be administered in three different forms
| Study group | Role | What they receive |
|---|---|---|
| Oral tablet | Active comparator | 3 mg Tablets (Nature Made). Participants will need to fast for 2 hours prior to consumption and 2 hours after consumption. Receives: Dietary Supplement: Melatonin |
| Lotion | Experimental | Dr. Teal's Sleep Lotion with Melatonin, Lavender, and Chamomile. 3 g lotion applied to one arm (without washing for at least 4 hours). Receives: Dietary Supplement: Melatonin |
| Bubble bath | Experimental | 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). Receives: Dietary Supplement: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary melatonin level
assessed via ELISA
Measured: from immediately prior to administration to 48 hours post administration
Secondary outcomes (1)
Side effects
Frequency of headache, drowsiness, dizziness, skin irritation, vivid dreams, and nightmares
Measured: from immediately prior to administration to 48 hours post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start19 May 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated measures crossover trial
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Redlands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa E Olson, Ph.D., Principal investigator, University of Redlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382610
- Sponsor's protocol ID
- 2024-002
- Status last verified
- Aug 2026
- First submitted
- 19 Apr 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upload salivary melatonin levels and side effect frequencies (all collected IPD) to National Sleep Research Resource (https://sleepdata.org/)
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations
- ClinicalTrials.gov ID
- NCT06382610
- Acronym / sponsor ID
- 2024-002
- Conditions
- Sleep
- Keywords
- melatonin, transdermal, oral, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of RedlandsUniversity, hospital or other
- Study start
- 19 May 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 24 Apr 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.
Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body.
Detailed description
Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. A previous study (unpublished) has shown that a small amount of an over-the-counter lotion increases salivary melatonin levels by up to 1000 fold, a startling amount. Researchers will characterize the time course of the absorption and metabolism of lotion- and bubble bath-based melatonin compared to oral tablets in healthy 18-21 year olds.
The peak level, time to peak level and half-life of melatonin will be compared between the administration routes using a within-person (repeated measures) design and saliva sampling over 48 hours. Participants can choose specific days to participate within a one-month window, with a maximum of four sampling periods. All participants will collect control saliva samples (no melatonin treatment) one night at 10 PM and 4 AM. Participants will be asked to have two treatments 1) oral melatonin and 2) either lotion melatonin or bubble-bath melatonin. Participants can indicate if they have a preference for lotion vs. bubble bath or if they are willing to undergo both lotion and bubble bath treatments (adding a fourth sampling period). Order will be randomized.
For the treatments, saliva sampling times are as follows: Prior to melatonin administration (10 AM), then 15 min, 30 min, 45 min, 60 min, 90 min, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours (10 PM), 18 hours (4 AM), 24 hours, 36 hours, and 48 hours after administration. Samples will be frozen at the participant's home until returned to the researchers at a later date. Melatonin in saliva samples will be quantitated via Enzyme Linked Immunosorbent Assay.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Repeated measures crossover trial
| Arm | Type | Receives |
|---|---|---|
| Oral tablet | Active comparator | Dietary Supplement: Melatonin3 mg Tablets (Nature Made). Participants will need to fast for 2 hours prior to consumption and 2 hours after consumption. |
| Lotion | Experimental | Dietary Supplement: MelatoninDr. Teal's Sleep Lotion with Melatonin, Lavender, and Chamomile. 3 g lotion applied to one arm (without washing for at least 4 hours). |
| Bubble bath | Experimental | Dietary Supplement: MelatoninDr. 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). |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- University of Redlands student
Key exclusion criteria (2 listed)
- Allergies or sensitivities to scented lotions or bath products
- Pregnancy
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 |
|---|---|---|
| MelatoninMelatonin will be administered in three different forms | Dietary supplement | Bubble bath, Lotion, Oral tablet |
Primary outcome
Salivary melatonin level
Time frame: from immediately prior to administration to 48 hours post administration
assessed via ELISA
1 secondary outcome
Side effects
Time frame: from immediately prior to administration to 48 hours post administration
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 11 Aug 2026.
- Individual participant dataSharing planned: Yes. Upload salivary melatonin levels and side effect frequencies (all collected IPD) to National Sleep Research Resource (https://sleepdata.org/)
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Healthy Adult Participants
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.
Lisa E Olson, Ph.D. principal investigator
University of Redlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Sleep, run by University of Redlands 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 1 inclusion and 2 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 11 Aug 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Salivary melatonin level (time frame: from immediately prior to administration to 48 hours post administration). 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 11 Aug 2026.