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Skincare Products and Environmental Health

NCT ID: NCT04836364

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-14

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Gynecomastia Endocrine System Diseases

Keywords

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Prepubertal Gynecomastia Essential Oils Lavender Tea Tree Endocrine Disruption Pediatric Environmental Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pediatric Cohort

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

No Intervention

Intervention Type OTHER

There is no intervention; observation only.

Interventions

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No Intervention

There is no intervention; observation only.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutraceuticals Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Franklin Health Research Center

Franklin, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Jessie Hawkins, PhD

Role: primary

Other Identifiers

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19-03-1700

Identifier Type: -

Identifier Source: org_study_id