Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
A multicentre review of the footwear allergens tested in the UK
Author:
Katugampola RP, Statham BN, English JSC, Wilkinson MM, Foulds IS, Green CM, Ormerod AD, Stone NM, Horne HL and Chowdhury MMU
Year:
2005
Bibliographic source:
Contact Dermatitis 53: 133-135

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The aim of the study is to ascertain the footwear allergens currently in use and their test reseults in several dermatology centres in the UK.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Method

Ethical approval:
confirmed, but no further information available
Details on study design:
Patch test data to footwear allergens over the last 2-6 years were collected from databases in 9 dermatology centres in the UK. All the participating clinicians were members of the BCDS (British Contact Dermatitis Society).
The data collected from each centre were as follows :
(1) Name of allergens tested
(2) Number of tests performed for each allergen
(3) Number of positive reactions that were of current or past relevance for each allergen according to the International Contact Dermatitis Research Group.
The relevance of the positive reactions was based on a combinaison of factors: location of the rash, improvement in the skin complaint after withdrawal of the suspected item of footwear and, where possible, a positive patch test to samples from the item of footwear.

Results and discussion

Results of examinations:
Irritant reactions were seen for dibutylthiourea (1/1149 = 0.08%)

Applicant's summary and conclusion

Executive summary:

Footwear allergens used for patch testing vary between dermatology centres in the UK. The aim of the study is to ascertain the footwear allergens currently in use and their test reseults in several dermatology centres in the UK. Data were obtained from databases in 9 dermatology departments. A new footwear series consisting of 19 allergens including those with positive results and current/past relevance in this study based on collective experience is proposed for wider use and further evaluation.

Irritant reactions were seen for dibutylthiourea (1/1149 = 0.08%)