Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04919434 |
| Other study ID # |
C20-81 |
| Secondary ID |
2021-A00215-36 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2021 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
June 2021 |
| Source |
Institut National de la Santé Et de la Recherche Médicale, France |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Main objective The intervention study IRECO aims to (1) modify habits of personal care
product use for the participants and (2) evaluate the impact of those modification on urinary
concentration for the following compounds: phthalates, phenols and glycol ether.
Secondary objectives:
The secondary objectives of this study aim to evaluate:
1. impact of modification of personal care product on the levels of biomarkers linked to
exposure to environmental pollutant other than phthalates phenol and glycol ether
(untargeted analysis) and biomarkers related to health (such as inflammatory biomarkers
and oxidative stress).
2. hazard perception linked to the exposure to chemical product present in personal care
product
3. barriers to change habits allowing to decrease exposure to environmental pollutant on
short and long term as well as levers allowing to remove those barriers.
Description:
Many chemical compounds are allowed as ingredients in personal care product. Among those
substances, phenols, phthalates and some glycol ether are widely detected in personal care
product. Few epidemiological studies suggested association between the use of personal care
product and higher urinary concentration of parabens, phthalates, bisphenol A and triclosan.
In France, studies in general population also show those associations and suggested higher
urinary concentration of some glycol ethers in users of cosmetics, (make up, nail polish,
nail polish remover), deodorant, and care product (cream, lotion etc.) The intervention study
IRECO (Intervention to Reduce Exposure to environmental Contaminant) aims to study the impact
of personal care product on exposure levels of compounds from phenol, phthalates and glycol
ether. This project will allow to better characterize sources of exposure of those chemical
compounds for which deleterious effect on health is suspected. The results of this study will
be informative and will allow to bring concrete solutions to the general population who wish
to reduce their exposure. The study will also allow to help decision maker in trying to limit
exposure to chemical compounds such as phthalates and phenols in daily consumption product.
To date, these type of intervention studies were conducted in the USA and no study have been
done in France so far where regulation and consumption habits differs from the USA.
The two main objectives of the intervention study IRECO are: (1) modify habits of personal
care product use for the participants and (2) evaluate the impact of those modification on
urinary concentration for the following compounds: phthalates, phenols and glycol ether.
To meet those objectives, 100 women with the following inclusion criteria will be included in
the study : (1) aged between 18 and 30 years, (2) accept to not use personal care product or
use only the alternative personal care product distributed by the research team for 5 days,
(3) to not have any known allergies to ingredients in the alternative personal care product,
(4) to benefit from the French health assurance ; (5) live in the area of Grenoble (France)
(6) speak French fluently, (7) have a freezer to store the urine collected.
The study follow-up will include 12 days of measure divided in three phases :
1. - The pre-intervention phase which will last for 3 days and during which the volunteer
will (1) collect a sample of each miction with collection tubes given by a field worker,
store those urines in her freezer and (2) use an application to collect data on use of
personal care product, cleaning product, food drinks and drugs intakes as well as the
hour of each miction. At the end of the pre-intervention phase, 24ml of blood will be
withdrawn and a semi-structured interview will be conducted aiming to evaluate
volunteer's knowledge on the studied compounds, the presence of those compounds in the
ingredients of personal care product and the hazard linked to the exposure of those
compounds.
2. - The intervention phase will last 5 days during which the volunteers will: (1) stop
using her personal care product and use the alternative ones distributed by the research
team , (2) collect a sample of each miction with collection tubes given by a field
worker, store those urines in her freezer and (3) use an application to collect data on
use of personal care product, cleaning product, food drinks and drugs intakes as well as
the hour of each miction. At the end of the pre-intervention phase, 24ml of blood will
be withdrawn
3. - The post intervention phase will last 4 days during which the volunteers will: (1)
collect a sample of each miction with collection tubes given by a field worker, store
those urines in her freezer and (2) use an application to collect data on use of
personal care product, cleaning product, food drinks and drugs intakes as well as the
hour of each miction
2 months after the intervention a fieldworker will go the volunteer's home to conduct a
semi-structured interview on her changes in the use of personal care product following her
participation into the intervention study IRECO.
