Skincare Products and Environmental Health

NCT04836364 — Unknown, 2000 participants, Nutraceuticals Research Institute

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Prevalence of Endocrine Disorders Among Children Exposed to Lavender Essential Oil and Tea Tree Essential Oils

Registry	NCT04836364
Status	Unknown
Study type	Observational
Enrollment	2000 (Estimated)
Sponsor	Nutraceuticals Research Institute (Other)
Conditions	Gynecomastia, Endocrine System Diseases
Interventions	No Intervention (Other)
Dates	start 2019-01-14, primary completion 2022-06-30 (estimated), completion 2022-12-31 (estimated), first posted 2021-04-08, last updated 2021-11-01
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Pediatric Cohort		Other: No Intervention	Parents of children ages 2 to 15 years old will provide data using the APICHS.

No Intervention (Other): There is no intervention; observation only.

+Outcome measures

Primary outcomes

Lifetime prevalence of prepubertal gynecomastia [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 [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 [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.

+Eligibility

Sex: All, ages: 2 Years to 15 Years

Inclusion Criteria:

* Parent of child aged 2-15 living in the United States

Exclusion Criteria:

* none

+Locations (1)

Facility	City	Country	Status
Franklin Health Research Center	Franklin, Tennessee	United States	Recruiting

My Notes

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