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
|Condition or disease||Intervention/treatment|
|Gynecomastia Endocrine System Diseases||Other: No Intervention|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|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|
Parents of children ages 2 to 15 years old will provide data using the APICHS.
Other: No Intervention
There is no intervention; observation only.
- 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
- 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
- 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.
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
|United States, Tennessee|
|Franklin Health Research Center||Recruiting|
|Franklin, Tennessee, United States, 37067|
|Contact: Jessie Hawkins, PhD 615-642-1919 firstname.lastname@example.org|