Skincare Products and Environmental Health

• Conditions: Gynecomastia; Endocrine System Diseases
• Interventions: Other: No Intervention

• Registration Number: NCT04836364
• Lead Sponsor: Franklin Health Research

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.

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 Timeline

• Study Start: 2019-01-14
• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric Cohort	No Intervention	Parents of children ages 2 to 15 years old will provide data using the APICHS.

Primary Outcome Measures

Name	Time	Method
Lifetime prevalence of precocious puberty	Baseline	The number of participants who were exposed to lavender and tea tree essential oils and experienced prepubertal gynecomastia
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
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.

Trial Locations

Locations (1)

Franklin Health Research Center; 🇺🇸 Franklin, Tennessee, United States