Skincare Products and Environmental Health
Prevalence of Endocrine Disorders Among Children Exposed to Lavender Essential Oil and Tea Tree Essential Oils
1 other identifier
observational
2,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2019
CompletedFirst Submitted
Initial submission to the registry
April 5, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedNovember 1, 2021
October 1, 2021
3.5 years
April 5, 2021
October 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Baseline
Lifetime prevalence of precocious puberty
The number of participants who were exposed to lavender and tea tree essential oils and experienced prepubertal gynecomastia
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.
Baseline
Study Arms (1)
Pediatric Cohort
Parents of children ages 2 to 15 years old will provide data using the APICHS.
Interventions
Eligibility Criteria
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.
You may qualify if:
- Parent of child aged 2-15 living in the United States
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Franklin Health Research Center
Franklin, Tennessee, 37067, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2021
First Posted
April 8, 2021
Study Start
January 14, 2019
Primary Completion
June 30, 2022
Study Completion
December 31, 2022
Last Updated
November 1, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share