Intervention to Reduce Exposure to Environmental COntaminant (IRECO)

NCT04919434 | Active Not Recruiting DMC

• 2 other identifiers: C20-812021-A00215-36
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.hazard perception linked to the exposure to chemical product present in personal care product
3. 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.

Conditions

Exposure

Keywords

intervention study; chemical assessment; personal care product

Outcome Measures

Primary Outcomes (1)

• 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.

  follow-up 1 week

Secondary Outcomes (3)

• Modification of exposure other than phthalates, phenols and glycol ether

  follow-up 1 week

• Hazard perception linked to the exposure to chemical product present in personal care product

  during the follow-up week.

• Barriers to change habits in the use of personal care product

  during the follow-up week and 2 months after the intervention

Study Arms (1)

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

Other: IRECO

Interventions

IRECO OTHER

During 5 days, women included in the study will have to only use personal care product distributed by the research team.

Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• live in Grenoble area
• speak french fluently
• have a freezer to store the urine sample for a week

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Institut pour l'avancée des biosciences IAB (U1209)/hôpital couple enfant du CHU Grenoble-Alpes

Grenoble, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 9, 2021
• Study Start: June 26, 2022
• Primary Completion: July 16, 2024
• Study Completion (Estimated): June 25, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

FR (1)