Skincare Products and Environmental Health

Sponsor

Franklin Health Research (Other)

Overall Status

Recruiting

CT.gov ID

NCT04836364

Collaborator

(none)

2,000

Enrollment

Location

47.5

Anticipated Duration (Months)

42.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecomastia Endocrine System Diseases	Other: No Intervention

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

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 14, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Pediatric Cohort Parents of children ages 2 to 15 years old will provide data using the APICHS.	Other: No Intervention There is no intervention; observation only.

Arm

Intervention/Treatment

Pediatric Cohort

Parents of children ages 2 to 15 years old will provide data using the APICHS.

Other: No Intervention

There is no intervention; observation only.

Outcome Measures

Primary Outcome Measures

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.