GynecomastiaNCT04836364
Skincare Products and Environmental Health
An observational study of Gynecomastia and Endocrine System Diseases, run by Nutraceuticals Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to explore the potential for an association between the development of prepubertal gynecomastia and history exposure to lavender essential oil, tea tree essential oil, and other essential oils. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Gynecomastia, Endocrine System Diseases
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 31 Dec 2022
- Phase
- Observational
- 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 2 to 15 years
- All sexes
- Child
Study population: Parents of children aged 2 to 15 years old who live in the United States will be recruited for this study. Emphasis is placed on obtaining a diverse sample which all states and territories, in addition to a racially and SES diverse sample.
Who may be able to join
- Parent of child aged 2-15 living in the United States
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Franklin Health Research Center
Franklin, Tennessee, 37067
Jessie Hawkins, PhD, 615-642-1919, j.hawkins@franklinhealth.org
About this study
Official title: Prevalence of Endocrine Disorders Among Children Exposed to Lavender Essential Oil and Tea Tree Essential Oils
The purpose of this study is to explore the potential for an association between the development of prepubertal gynecomastia and history exposure to lavender essential oil, tea tree essential oil, and other essential oils.
Read the detailed description
After being informed about the study and privacy, parents will give informed consent and complete the APICHS (Aromatic Plant Ingredient \& Child Health Survey), a validated measurement tool for determining exposure to plant-based ingredients in pediatric personal care products.
- Conditions
- Gynecomastia, Endocrine System Diseases
- Being tested
- No Intervention
- Keywords
- Prepubertal Gynecomastia, Essential Oils, Lavender, Tea Tree, Endocrine Disruption, Pediatric Environmental Health
- Medical subject headings
- Gynecomastia, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
There is no intervention; observation only.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Cohort | Parents of children ages 2 to 15 years old will provide data using the APICHS. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifetime prevalence of prepubertal gynecomastia
The number of participants who were exposed to lavender and tea tree essential oils and had ever experienced prepubertal gynecomastia
Measured: Baseline
Lifetime prevalence of precocious puberty
The number of participants who were exposed to lavender and tea tree essential oils and experienced prepubertal gynecomastia
Measured: Baseline
Endocrine Disruption - Comparison between exposed and unexposed
The difference in rates of endocrine disorders between children who were exposed to lavender or tea tree essential oil and those who were not. Exposure is measured using the Aromatic Plant Ingredient and Child Health Survey (APICHS), which measures total exposure, providing a continuous variable ranging from 0 to unlimited exposures, and a dichotomous yes/no exposure outcome variable.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start14 Jan 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecomastiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836364
- Sponsor's protocol ID
- 19-03-1700
- Status last verified
- Oct 2021
- First submitted
- 5 Apr 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Endocrine Disorders Among Children Exposed to Lavender Essential Oil and Tea Tree Essential Oils
- ClinicalTrials.gov ID
- NCT04836364
- Acronym / sponsor ID
- 19-03-1700
- Conditions
- Gynecomastia, Endocrine System Diseases
- Keywords
- Prepubertal Gynecomastia, Essential Oils, Lavender, Tea Tree, Endocrine Disruption, Pediatric Environmental Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Apr 2021 (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.
The purpose of this study is to explore the potential for an association between the development of prepubertal gynecomastia and history exposure to lavender essential oil, tea tree essential oil, and other essential oils.
Detailed description
After being informed about the study and privacy, parents will give informed consent and complete the APICHS (Aromatic Plant Ingredient \& Child Health Survey), a validated measurement tool for determining exposure to plant-based ingredients in pediatric personal care products.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Cohort | – | Other: No InterventionParents of children ages 2 to 15 years old will provide data using the APICHS. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Parents of children aged 2 to 15 years old who live in the United States will be recruited for this study. Emphasis is placed on obtaining a diverse sample which all states and territories, in addition to a racially and SES diverse sample.
Key inclusion criteria (1 listed)
- Parent of child aged 2-15 living in the United States
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| No InterventionThere is no intervention; observation only. | Other | Pediatric Cohort |
Primary outcome
Lifetime prevalence of prepubertal gynecomastia
Time frame: Baseline
The number of participants who were exposed to lavender and tea tree essential oils and had ever experienced prepubertal gynecomastia
Lifetime prevalence of precocious puberty
Time frame: Baseline
The number of participants who were exposed to lavender and tea tree essential oils and experienced prepubertal gynecomastia
Endocrine Disruption - Comparison between exposed and unexposed
Time frame: Baseline
The difference in rates of endocrine disorders between children who were exposed to lavender or tea tree essential oil and those who were not. Exposure is measured using the Aromatic Plant Ingredient and Child Health Survey (APICHS), which measures total exposure, providing a continuous variable ranging from 0 to unlimited exposures, and a dichotomous yes/no exposure outcome variable.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecomastia and Endocrine System Diseases, run by Nutraceuticals Research Institute 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 1 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: status not confirmed, as of the sponsor's last update on 1 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifetime prevalence of prepubertal gynecomastia (time frame: Baseline). The study lists 3 primary outcomes in all. 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 1 Nov 2021.