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Quaternary Ammonium and Immunization in Hairdressers

Quaternary Ammonium and Immunization in Hairdressers

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05247567
Acronym
AQTIFF
Enrollment
1
Registered
2022-02-21
Start date
2022-10-27
Completion date
2022-10-27
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity, Quaternary Ammonium

Keywords

hypersensitivity, hairdressers, quaternary ammonium

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.

Interventions

BIOLOGICALserum punction

A blood sample inclusion and at the end of study visit

BIOLOGICALskin swab in elbow folds

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Difference between prevalence of quaternary ammonium sensitization between first and third year hairdressing students1 daySensitization will be evaluated as the percentage of students with serum anti-Quaternary Ammonium IgE concentration \>0,35 KU/L

Secondary

MeasureTime frameDescription
Comparison of quaternary ammonium sensitization of hairdresser to a age-matched birth cohort1 dayThe 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 collected1 dayMeasure 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 study2 years
the relative variation of IgG anti-quaternary ammonium concentrations of first year students at inclusion and after two years of study2 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026