Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05247567 |
| Other study ID # |
APHP211212 |
| Secondary ID |
2021-A01722-39 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 27, 2022 |
| Est. completion date |
October 27, 2022 |
Study information
| Verified date |
March 2024 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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. "
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."
