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NCT04836364 Clinical Trial

Skincare Products and Environmental Health

Endocrine System Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04836364
Other study ID # 19-03-1700
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 14, 2019
Est. completion date December 31, 2022

Study information
Verified date October 2021
Source Franklin School of Integrative Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers
Gender All
Age group 2 Years to 15 Years
Eligibility Inclusion Criteria: - Parent of child aged 2-15 living in the United States Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Franklin Health Research Center Franklin Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Franklin School of Integrative Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Lifetime prevalence of precocious puberty The number of participants who were exposed to lavender and tea tree essential oils and experienced prepubertal gynecomastia Baseline
Primary 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
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