GB2492361A - Micropatch for contact allergy testing - Google Patents
Micropatch for contact allergy testing Download PDFInfo
- Publication number
- GB2492361A GB2492361A GB1111037.6A GB201111037A GB2492361A GB 2492361 A GB2492361 A GB 2492361A GB 201111037 A GB201111037 A GB 201111037A GB 2492361 A GB2492361 A GB 2492361A
- Authority
- GB
- United Kingdom
- Prior art keywords
- micropatch
- text
- less
- application area
- optionally
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0035—Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
- A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/683—Means for maintaining contact with the body
- A61B5/6832—Means for maintaining contact with the body using adhesives
- A61B5/6833—Adhesive patches
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Pathology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- Vascular Medicine (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
A micropatch is used to apply allergens to the skin in existing diagnostic patch test concentrations. The micropatch of the present invention provides a reliable and effective system of elicitation necessary for the diagnostic identification of allergy cases whilst substantially reducing the chances of sensitising subjects. The application area of the micropatch may be less than 0.5cm2, most preferably less than 0.1cm2, and is applied to the upper arm rather than the back. The micropatch may be provided by a small chamber or stamp.
Description
A micropatch for assessing chemical contact allergy The invention relates to a micropatch for use in chemical contact allergy testing to identify individuals exhibiting contact allergy to one or more allergens.
Current screening methods for chemical contact allergy typically consists of applying allergens in petrolatum using an 8 mm diameter (0.5 cm2) aluminium chamber, an8mm x 8 mm square plastic chamber, or a i0mm x 10mm impregnated stamp. The allergens are part of a collection of common allergens (e.g., the European Baseline Series) which arc usually applied to the upper back for 2 days.
When the allergens are removed the skin is read for any reaction at this time and again a further 1-5 days later using standardised criteria (e.g., ICDRG criteria) (Fregert S. Manual of Contact Dermatitis, 2 Edition Copenhagen, Munksgaard 1981).
A positive reaction indicates contact allergy to the allergen(s) in question.
The standard method for screening for hair dye allergy is with the allergen aromatic amine para-phenylenediamine (PPD). In European clinics typically between 2% and 5% of patients screened are positive for PPD allergy (Thyssen JP, White JM. Epidemiological data on consumer allergy to p-phcnylcncdiamine. Contact Dermatitis 2008: 59: 327-3).
However, active sensitisation caused by the PPD diagnostic patch test itself (ie. the patient becomes sensitised as a result of the actual diagnostic process) is a significant problem. The frequency with which this occurs is disputed, some reports rate the incidence as high as 1.5% (Dcvos SA, van der Valk PG. The risk of active sensitisation to p-phenylenediamine.
Contact Dermatitis 20W; 44: 273-275) whilst others report the rate of sensitisation caused by the test to be less than 0.2% (Dawe SA, White IR, Rycrofi RJG et al. Active sensitisation to para-phenylenediamine and its relevance: a 10-year review. Contact Dermatitis 2004; 51: 96-97).
Nevertheless, of all the allergens used in standard chemical contact allergy screening, PPD is generally regarded as the allergen most likely to cause active sensitisation.
In an attempt to reduce the frequency with which sensitisation occurs, testing at a reduced concentration has been attempted. However, this more than halves the rate of detection of allergic individuals, rendering the test useless as a screen for detecting hair dye allergy.
A need exists for an accurate and reliable means of identifying allergic individuals which does not expose subjects to the risk of becoming sensitised by the test itself In a first aspect the invention relates to a mieropatch for chemical contact allergy testing to identify individuals exhibiting contact allergy to one or more allergen having an application area of less than 0.5 cm2 In another aspect the invention relates to a mieropatch wherein the micropatch is pmvided by a small chamber.
In another aspect the invention relates to a micropatch wherein the micropatch is provided by a stamp.
Detailed Description:
The present invention is based on the realisation that the key to separating, and so reducing, the risk of the induction of skin sensitisation from the need to elicit a skin reaction for the purposes of diagnosis is for the latter to employ a skin area below that required for effective induction, but which remains effective for elicitation.
The critical factor in determining whether the induction of allergic sensitisation (becoming aflergic) to a single allergen skin exposure is the dose per unit area (mg/cm2) (Kimber I, Dearman R J, Basketter D A, Ryan C A, Gerberick G F, Lalko J and Api A M. (2008) Dose metrics in the acquisition of skin sensitization: thresholds and importance of dose per unit area. Regulatory Toxicol Pharmacol 2008; 52: 39 -45).
It does not matter whether the exposed area is 1 cm2 or 10 cm2, if the dose per unit area is the same then the chances of becoming sensitised are the same (Friedman PS The relationship between exposure dose and response in induction and elicitation of contact hypersensitivity in humans. Br J Dermatol 2007; 81: 507-59).
However, this relationship breaks down at very low areas of application (Rees JL, Friedmann PS, Matthews JN. The influence of area of application on sensitization by dinitrochlorobenzcnc. British Journal Dermatology 1990; 122 (6): 29-31). Report that 96% of subjects were sensitiscd when exposed to the strong allergen 2,4-dinitrochlorobenzene (approximately equivalent in strength to PPD) when applied to 0.8 cm2 of skin, but only 26% of subjects were sensitised when the same dose/unit area was applied to an area of skin of 0.08 em2.
The micropatch of the present invention provides a reliable and effective system of elicitation neccssary thr the accurate identification of allergy cases whilst substantially reducing the chances of sensitising subjects.
The present invention provides a variety of micropatches of different types being chambers or impregnated stamps each having an application area of less than 0.5 cm2. Preferably the micropatch is provided by a small chambcr or stamp' as is well known in the art.
Optionally the micropatch has an application area of less than 0.45 cm2.
Optionally the niicropatch has an application area of less than 0.4 cni2.
Optionally the micropatch has an application area of less than 0.35 cm2.
Optionally the micropatch has an application area of less than 0.3 cm2.
Optionally the micropatch has an application area of less than 0.25 cm2.
Optionally the micropatch has an application arca of less than 0.2 cm2.
Optionally the micropatch has an application area of less than 0.15 cm2.
Optionally the micropatch has an application area of less than 0.1 cm2.
Optionally the micropatch has an application area of less than 0.05 cm2.
Optionally the micropatch has an application area of less than 0.04 cm2.
Optionally the micropatch has an application area of less than 0.03 cni2.
Optionally the micropatch has an application ama of less than 0.02 cm2.
Optionally the micropatch has an application area of less than 0.01 cm2.
Optionally the micropatch has an application area of less than 0.005 cm2.
Preferably the micropatch is used to apply allergens in the existing diagnostic patch test concentrations. Optionally the concentration and/or the vehicle employed can be varied as neccssary.
The micropatch may be applied to any suitable site on the body, more preferably the micropatch may be applied to the upper arm; thus avoiding any potential, theoretical enhancement of sensitisation risk caused by lymphatic drainage of other allergens, as may occur when multiple patches are applied to thc back.
Claims (1)
- <claim-text>C I aims: 1. A micropatch for chemical contact allergy testing to identify individuals exhibiting contact allergy to one or more allergen having an application area of less than 0.5 cm2.</claim-text> <claim-text>2. A micropatch as claimed in claim 1 wherein the micropatch is provided by a small chambcr.</claim-text> <claim-text>3. A micropatch as claimcd in claim 1 wherein thc micropatch is provided by a stamp.</claim-text> <claim-text>4. A micropatch as claimed in any preceding claim having an application area of less than 0.4 cm2.</claim-text> <claim-text>5. A micropatch as claimed [n any preceding claim having an application area of less than 0.3 cm2.</claim-text> <claim-text>6. A micropatch as claimed in any preceding claim having an application area of less than 0.2 cm2.</claim-text> <claim-text>7. A micropatch as claimed in any preceding claim having an application area of less than 0.1 cm2.</claim-text>
Priority Applications (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB1111037.6A GB2492361A (en) | 2011-06-29 | 2011-06-29 | Micropatch for contact allergy testing |
| PCT/EP2012/062579 WO2013001007A1 (en) | 2011-06-29 | 2012-06-28 | An improved micropatch for assessing chemical contact allergy |
| GB1211467.4A GB2492475A (en) | 2011-06-29 | 2012-06-28 | Micropatch for contact allergy testing |
| US14/129,802 US20140241995A1 (en) | 2011-06-29 | 2012-06-28 | Micropatch for assessing chemical contact allergy |
| EP12732826.8A EP2726866A1 (en) | 2011-06-29 | 2012-06-28 | An improved micropatch for assessing chemical contact allergy |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB1111037.6A GB2492361A (en) | 2011-06-29 | 2011-06-29 | Micropatch for contact allergy testing |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| GB201111037D0 GB201111037D0 (en) | 2011-08-10 |
| GB2492361A true GB2492361A (en) | 2013-01-02 |
Family
ID=44485350
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| GB1111037.6A Withdrawn GB2492361A (en) | 2011-06-29 | 2011-06-29 | Micropatch for contact allergy testing |
Country Status (1)
| Country | Link |
|---|---|
| GB (1) | GB2492361A (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0252044A1 (en) * | 1986-06-26 | 1988-01-07 | Pharmacia Ab | Test strip and method for epicutaneous testing |
| US20080241199A1 (en) * | 2007-03-30 | 2008-10-02 | Silverman David G | "Micro-Patch" for Assessment of the Local Microvasculature and Microcirculatory Vasoreactivity |
| EP2119469A1 (en) * | 2007-02-06 | 2009-11-18 | Hisamitsu Pharmaceutical Co., Inc. | Microneedle device for diagnosis of allergy |
-
2011
- 2011-06-29 GB GB1111037.6A patent/GB2492361A/en not_active Withdrawn
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0252044A1 (en) * | 1986-06-26 | 1988-01-07 | Pharmacia Ab | Test strip and method for epicutaneous testing |
| EP2119469A1 (en) * | 2007-02-06 | 2009-11-18 | Hisamitsu Pharmaceutical Co., Inc. | Microneedle device for diagnosis of allergy |
| US20080241199A1 (en) * | 2007-03-30 | 2008-10-02 | Silverman David G | "Micro-Patch" for Assessment of the Local Microvasculature and Microcirculatory Vasoreactivity |
Non-Patent Citations (3)
| Title |
|---|
| British Journal of Dermatology, Vol. 122, 1990, Rees et al, 'The influence of area of application on sensitization by dinitrochlorobenzene', pp. 29-32 * |
| Journal of Investigative Dermatology, Vol. 47, 1966, Kligman, 'The identification of contact allergens by human assay. II. Factors influencing the induction and measurement of allergic contact dermatitis', pp. 375-392 * |
| Regulatory Toxicology and Pharmacology, Vol. 52, 2008, Kimber et al, 'Dose metrics in the acquisition of skin sensitization: Thresholds and importance of dose per unit area', pp. 39-45 * |
Also Published As
| Publication number | Publication date |
|---|---|
| GB201111037D0 (en) | 2011-08-10 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| WAP | Application withdrawn, taken to be withdrawn or refused ** after publication under section 16(1) |