Allergy Alert Test-Proof of Concept Study
Research type
Research Study
Full title
Allergy Alert Test-Proof of Concept Study
IRAS ID
107688
Contact name
Catherine Ruth Holden
Contact email
Sponsor organisation
L'Oréal Research and Innovation
Research summary
Allergic contact reactions to hair dyes can be severe, with the dyes para-phenylenediamine (PPD) and p-Toluenediamine (PTD) being the most common allergens. Allergic contact reactions can be severe enough in some cases to result in hospitalisation and/or the need for oral steroids to control the reaction. To try and avoid this hair dye manufacturers instruct consumers to test the hair dye on themselves before colouring their hair. There are current limitations surrounding this including: Skin reactions to these tests in previous studies have been read by dermatologists and not by the target group (the consumer or hairdresser), Recommendations and instructions as to how to perform the self-tests vary greatly between companies and even among products from the same company.
A working group in April 2011, reported in 11/SANCO/COS/29 the current outstanding issues and made the following recommendations:
The industry should develop a new concept for the test, addressing the need for harmonisation and standardisation.
The industry proposed to call the skin sensitivity test “Allergy Alert Test”.
This study is the product of those recommendations, and the results will be reported back to the industry.Consumers known to be allergic to PPD (used as a model allergen) and with a history of allergic reactions to hair dyes will be included in the study. The parameters are: Contact time: 45 minutes. Product: An “in use” mixture of hair colourant formula and developer. Positive results to the allergy alert test will be evaluated both by a Dermatologist experienced in such readings and self-evaluation. Both the inside of the forearm and behind the ear will be tested. The Allergy Alert Test should alert the consumer not to apply the product when experiencing any sensory or physically noticeable deviation from normal conditions and to seek medical advice.
The study will be multi-centred across Europe.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0152
Date of REC Opinion
12 Jun 2014
REC opinion
Further Information Favourable Opinion