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Quaternary Ammonium and Immunization in Hairdressers (AQTIFF)

Primary Purpose

Quaternary Ammonium, Hypersensitivity

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
serum punction
skin swab in elbow folds
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Quaternary Ammonium focused on measuring hypersensitivity, hairdressers, quaternary ammonium

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria :

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

Exclusion criteria :

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

Sites / Locations

  • Bichat HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

First year students

Third year students

Arm Description

Students in their first year of Hairdressing School

Students in their third year of Hairdressing School

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of quaternary ammonium sensitization of hairdresser to a age-matched birth cohort
The difference in prevalence of quaternary ammonium sensitization (seric IgE>0,35 kU/L) between the first year students and a reference population of the same age and geographic origin
Evaluation of the link between quaternary ammonium sensitization and other measured biological parameters and clinical data collected
Measure of the correlation between all collected parameters and concentrations of anti-quaternary ammonium concentrations
the relative variation of IgE anti-quaternary ammonium concentrations of first year students at inclusion and after two years of study
the relative variation of IgG anti-quaternary ammonium concentrations of first year students at inclusion and after two years of study

Full Information

First Posted
February 9, 2022
Last Updated
April 14, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05247567
Brief Title
Quaternary Ammonium and Immunization in Hairdressers
Acronym
AQTIFF
Official Title
Quaternary Ammonium and Immunization in Hairdressers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. "
Detailed Description
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 first cause of occupational rhinitis since 2000. Several studies have found a link between exposure to some disinfectants and asthma in specific population. The responsibility of the QA in asthma can be demonstrated by in vivo testing (inhalation challenge). Some QA have been shown to directly activate the immune system, in particular didecyldimethylammonium chloride, a common disinfectant, that was demonstrated to act as a sensitizer. Neuromuscular blocking agents (NMBA) are drugs used during surgery to relax muscles. They all have QA moieties and can trigger sometimes severe IgE-mediated allergic reaction (anaphylaxis). The epitope of these drugs recognized by the Immunoglobulin E (IgE) antibodies are precisely the QA moieties. However, the origin of these IgE is unknown as a significant proportion of patients have anaphylaxis on the first exposure an NMBA. A study showed that exposure to QA found in hairdressing products was linked to anti-IgE QA and then might also be a risk factor to allergy to NMBA. Thus, QA exposure is strongly suspected to be linked to allergic diseases. 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. We hypothesize that it is possible to sensitize to QA by exposure to hairdressing products and then to declare allergic diseases. We plan to study this hypothesis in an observational prospective cohort of hairdressing students by measuring both sensitization markers in blood and QA exposure. The investigator will study 2 groups of hairdressing students : first year students, before the beginning of their apprenticeship in a Salon third year students Both groups will be programmed for a visit in the Center for Clinical Investigation of the Bichat Hospital, Paris, France. During this visit, after obtention of written consent, a blood sample (10 mL) will be collected in a serum collection tube, and a form about exposure to QA will be filled by the student. For first year students only, a similar visit will be planned at the end of their studies (2 years after inclusion) Serum will be collected and frozen in a biobank in Bichat Hospital. Total and QA specific IgE and Immunoglobulin G (IgG) will be measured. Differences in prevalence will be assessed by Fischer's exact test, the link between exposure levels and IgG and IgE levels will be assessed by Spearman correlation, and the evolution of IgE and IgG concentrations over time will be measured by a paired hypothesis test chosen according to data's distribution."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quaternary Ammonium, Hypersensitivity
Keywords
hypersensitivity, hairdressers, quaternary ammonium

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
First year students
Arm Type
Other
Arm Description
Students in their first year of Hairdressing School
Arm Title
Third year students
Arm Type
Other
Arm Description
Students in their third year of Hairdressing School
Intervention Type
Biological
Intervention Name(s)
serum punction
Intervention Description
A blood sample inclusion and at the end of study visit
Intervention Type
Biological
Intervention Name(s)
skin swab in elbow folds
Intervention Description
passage of a cotton swab in the crease of the elbow at the inclusion
Primary Outcome Measure Information:
Title
Difference between prevalence of quaternary ammonium sensitization between first and third year hairdressing students
Description
Sensitization will be evaluated as the percentage of students with serum anti-Quaternary Ammonium IgE concentration >0,35 KU/L
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Comparison of quaternary ammonium sensitization of hairdresser to a age-matched birth cohort
Description
The difference in prevalence of quaternary ammonium sensitization (seric IgE>0,35 kU/L) between the first year students and a reference population of the same age and geographic origin
Time Frame
1 day
Title
Evaluation of the link between quaternary ammonium sensitization and other measured biological parameters and clinical data collected
Description
Measure of the correlation between all collected parameters and concentrations of anti-quaternary ammonium concentrations
Time Frame
1 day
Title
the relative variation of IgE anti-quaternary ammonium concentrations of first year students at inclusion and after two years of study
Time Frame
2 years
Title
the relative variation of IgG anti-quaternary ammonium concentrations of first year students at inclusion and after two years of study
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria : Being at least 16 Being regularly registered in a Hairdressing school in first and second year Mastery of French language Exclusion criteria : No French speaking parents for underage students People under legal guardianship French special Health Insurance for non-residents (AME)"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luc de Chaisemartin, MD PhD
Phone
0140256897
Ext
+33
Email
luc.de-chaisemartin@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc de Chaisemartin, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bichat Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc de Chaisemartin, MD PhD
Phone
0140256897
Ext
+33
Email
luc.de-chaisemartin@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Quaternary Ammonium and Immunization in Hairdressers

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