NCT05247567

Brief Summary

"Quaternary ammonium ions (QA) are surfactants and microbicide products found in a large number of household products, disinfectants and cosmetics. Professional exposure to QA causes allergic diseases of the skin and lung (asthma). It is also the firs cause of occupational rhinitis since 2000. Several studies have found a link between exposure to some disinfectants and asthma in specific population. Moreover, a study showed that exposure to QA found in hairdressing products could also be a risk factor to allergy to neuro-muscular blocking agents. However, the prevalence of QA sensitization amongst hairdressers is not known, sensitization mechanisms have been poorly characterized. To date, there is no recommendation regarding QA exposure nor classification of QA by toxicity. Finally, the link between hairdressing QA and drug allergy have not been confirmed yet. The investigator hypothesize that it is possible to sensitize to QA by exposure to hairdressing products and then to declare allergic diseases. The investigator plan to study this hypothesis in an observational prospective cohort of hairdressing students by measuring both sensitization markers in blood and QA exposure. "

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

October 27, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2022

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

Same day

First QC Date

February 9, 2022

Last Update Submit

March 19, 2024

Conditions

Quaternary AmmoniumHypersensitivity

Keywords

hypersensitivityhairdressersquaternary ammonium

Outcome Measures

Primary Outcomes (1)

  • Difference between prevalence of quaternary ammonium sensitization between first and third year hairdressing students

    Sensitization will be evaluated as the percentage of students with serum anti-Quaternary Ammonium IgE concentration \>0,35 KU/L

    1 day

Secondary Outcomes (4)

  • Comparison of quaternary ammonium sensitization of hairdresser to a age-matched birth cohort

    1 day

  • Evaluation of the link between quaternary ammonium sensitization and other measured biological parameters and clinical data collected

    1 day

  • the relative variation of IgE anti-quaternary ammonium concentrations of first year students at inclusion and after two years of study

    2 years

  • the relative variation of IgG anti-quaternary ammonium concentrations of first year students at inclusion and after two years of study

    2 years

Study Arms (2)

First year students

OTHER

Students in their first year of Hairdressing School

Biological: serum punctionBiological: skin swab in elbow folds

Third year students

OTHER

Students in their third year of Hairdressing School

Biological: serum punctionBiological: skin swab in elbow folds

Interventions

serum punctionBIOLOGICAL

A blood sample inclusion and at the end of study visit

First year studentsThird year students
skin swab in elbow foldsBIOLOGICAL

passage of a cotton swab in the crease of the elbow at the inclusion

First year studentsThird year students

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being at least 16
  • Being regularly registered in a Hairdressing school in first and second year
  • Mastery of French language

You may not qualify if:

  • No French speaking parents for underage students
  • People under legal guardianship
  • French special Health Insurance for non-residents (AME)"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bichat Hospital

Paris, 75018, France

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Luc de Chaisemartin, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 21, 2022

Study Start

October 27, 2022

Primary Completion

October 27, 2022

Study Completion

October 27, 2022

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations

FR(1)