Recruiting

Skincare & Health

Sponsor:

Nutraceuticals Research Institute

Code:

NCT04836364

Conditions

Gynecomastia

Endocrine System Diseases

Eligibility Criteria

Sex: All

Age: 2 - 15

Healthy Volunteers: Not accepted

Interventions

No Intervention

Study Details

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.

Conditions

Gynecomastia

Endocrine System Diseases

Study ID

NCT04836364

Start date

Jan 14, 2019

Status verified date

Oct, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 15

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Pediatric Cohort

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

Interventions

No Intervention

There is no intervention; observation only.

Primary outcome measure

  • Lifetime prevalence of prepubertal gynecomastia [ Time Frame: Baseline ]
  • Lifetime prevalence of precocious puberty [ Time Frame: Baseline ]
  • Endocrine Disruption - Comparison between exposed and unexposed [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Franklin Health Research Center

Recruiting

Franklin, Tennessee, United States, 37067

Contacts

Jessie Hawkins, PhD

615-642-1919j.hawkins@franklinhealth.org

More Information

Sponsor

Nutraceuticals Research Institute

Last update posted

Nov 1, 2021

Last verified

Oct, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nutraceuticals Research Institute on 2021-11-01.