ExposureNCT04919434
Intervention to Reduce Exposure to Environmental COntaminant (IRECO)
A study testing IRECO in people with Exposure, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exposure
- What is being tested?
- IRECO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2022to 25 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- be a women
- be older than 18 and younger than 30
- accept to not use or use only the substitute personal care product for 5 days
- no know allergy to ingredients in personal care product
- no skin or allergy disease
- have a medical insurance
Show all 9Show fewer
- live in Grenoble area
- speak french fluently
- have a freezer to store the urine sample for a week
Who cannot join
- being pregnant
- working in a job manipulating personal care product
- participating in an other study on cosmetics, personal care product, diet or any other study that may affect exposure to the studied chemicals
Trial locations and contacts
1 site in 1 country.
France1 site
Institut pour l'avancée des biosciences IAB (U1209)/hôpital couple enfant du CHU Grenoble-Alpes
Grenoble
About this study
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:
Read more
The secondary objectives of this study aim to evaluate:
- 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).
- hazard perception linked to the exposure to chemical product present in personal care product
- 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.
Read the detailed 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 :
- - 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.
- - 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
- - 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.
- Conditions
- Exposure
- Being tested
- IRECO
- Keywords
- intervention study, chemical assessment, personal care product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRECOOther
During 5 days, women included in the study will have to only use personal care product distributed by the research team.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Women will be asked NOT to use their own personal care product during the intervention. They will only have to use the substitute one given by the research team Receives: Other: IRECO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of exposure to phthalates, phenols and glycol ether
Urinary concentration of phthalates, phenols and glycol ether will be measured in urine sample. Urinary concentration will be measured in the three phases of the study : before intervention (phase 1), during intervention (phase 2) and after intervention (phase 3). The level of urinary concentration will be compared between each phase : phase 1 versus phase 2 and phase 2 versus phase 3.
Measured: follow-up 1 week
Secondary outcomes (3)
Modification of exposure other than phthalates, phenols and glycol ether
An untargeted approach will be conducted where chemical pollutants other than phthalates, phenols and glycol ether will be measured in urines. Urinary concentration of pollutants will be measured in the three phases of the study : before intervention (phase 1), during intervention (phase 2) and after intervention (phase 3). The level of urinary concentration will be compared between : (a) phase 1 and phase 2 and (b) phase 2 and phase 3.
Measured: follow-up 1 week
Hazard perception linked to the exposure to chemical product present in personal care product
A qualitative analysis will be conducted with the data collected during the sociodemographic interview. The analysis will describe the hazard perception of the volunteers linked to the exposure to chemical products present in personal care product.
Measured: during the follow-up week.
Barriers to change habits in the use of personal care product
A qualitative analysis will be conducted with the data collected during the sociodemographic interview. The analysis will describe the 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.
Measured: during the follow-up week and 2 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start26 Jun 2022
- Primary completion16 Jul 2024
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExposureStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919434
- Sponsor's protocol ID
- C20-81
- Other IDs
- 2021-A00215-36
- Status last verified
- Apr 2026
- First submitted
- 26 May 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jovanovic N, Bright F, Thomsen C, Garlantezec R, Rocabois A, McEachan RR, Yang TC, Sakhi AK, Chevrier C, Mathy S, Slama R, Lyon-Caen S, Vrijheid M, Philippat C. Levers to decrease exposure to harmful chemicals: the case of Personal Care Products and cosmetics. Environ Int. 2026 May;211:110243. doi: 10.1016/j.envint.2026.110243. Epub 2026 Apr 7.
PubMed 42001662
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Reduce Exposure to Environmental COntaminant (IRECO)
- ClinicalTrials.gov ID
- NCT04919434
- Acronym / sponsor ID
- C20-81
- Conditions
- Exposure
- Keywords
- intervention study, chemical assessment, personal care product
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- hazard perception linked to the exposure to chemical product present in personal care product
- 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.
Detailed 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 :
- - 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.
- - 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
- - 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: IRECOWomen will be asked NOT to use their own personal care product during the intervention. They will only have to use the substitute one given by the research team |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- be a women
- be older than 18 and younger than 30
- accept to not use or use only the substitute personal care product for 5 days
- no know allergy to ingredients in personal care product
- no skin or allergy disease
Key exclusion criteria (3 listed)
- being pregnant
- working in a job manipulating personal care product
- participating in an other study on cosmetics, personal care product, diet or any other study that may affect exposure to the studied chemicals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRECODuring 5 days, women included in the study will have to only use personal care product distributed by the research team. | Other | Intervention |
Primary outcome
Modification of exposure to phthalates, phenols and glycol ether
Time frame: follow-up 1 week
Urinary concentration of phthalates, phenols and glycol ether will be measured in urine sample. Urinary concentration will be measured in the three phases of the study : before intervention (phase 1), during intervention (phase 2) and after intervention (phase 3). The level of urinary concentration will be compared between each phase : phase 1 versus phase 2 and phase 2 versus phase 3.
3 secondary outcomes
Modification of exposure other than phthalates, phenols and glycol ether
Time frame: follow-up 1 week
Hazard perception linked to the exposure to chemical product present in personal care product
Time frame: during the follow-up week.
Barriers to change habits in the use of personal care product
Time frame: during the follow-up week and 2 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Results publication: PubMed 42001662Jovanovic N, Bright F, Thomsen C, Garlantezec R, Rocabois A, McEachan RR, Yang TC, Sakhi AK, Chevrier C, Mathy S, Slama R, Lyon-Caen S, Vrijheid M, Philippat C. Levers to decrease exposure to harmful chemicals: the case of Personal Care Products and cosmetics. Environ Int. 2026 May;211:110243. doi: 10.1016/j.envint.2026.110243. Epub 2026 Apr 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRECO in people with Exposure, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of exposure to phthalates, phenols and glycol ether (time frame: follow-up 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04919434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.