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Skincare Products and Environmental Health

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ClinicalTrials.gov Identifier: NCT04836364
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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 : January 14, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. Lifetime prevalence of prepubertal gynecomastia [ Time Frame: Baseline ]
    The number of participants who were exposed to lavender and tea tree essential oils and had ever experienced prepubertal gynecomastia

  2. Lifetime prevalence of precocious puberty [ Time Frame: Baseline ]
    The number of participants who were exposed to lavender and tea tree essential oils and experienced prepubertal gynecomastia

  3. Endocrine Disruption - Comparison between exposed and unexposed [ Time Frame: 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.



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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Parents of children aged 2 to 15 years old who live in the United States will be recruited for this study. Emphasis is placed on obtaining a diverse sample which all states and territories, in addition to a racially and SES diverse sample.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04836364


Locations
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United States, Tennessee
Franklin Health Research Center Recruiting
Franklin, Tennessee, United States, 37067
Contact: Jessie Hawkins, PhD    615-642-1919    j.hawkins@franklinhealth.org   
Sponsors and Collaborators
Franklin Health Research
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Responsible Party: Franklin Health Research
ClinicalTrials.gov Identifier: NCT04836364    
Other Study ID Numbers: 19-03-1700
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franklin Health Research:
Prepubertal Gynecomastia
Essential Oils
Lavender
Tea Tree
Endocrine Disruption
Pediatric Environmental Health
Additional relevant MeSH terms:
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Gynecomastia
Endocrine System Diseases
Breast Diseases
Skin Diseases