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Publication Number

US-9539318-B2

Patent

Publication Date

2017-01-10

Expiration Date


Abstract

The present application relates to a method for desensitization of allergic patients. More specifically it relates to an epicutaneous desensitization method, applicable to any type of allergens and of patients. The method of the invention is essentially non-invasive and does not require the use of adjuvants. Further, it may be easily applied and monitored by the actual patient.

Core Innovation

The invention relates to an epicutaneous desensitization method for a subject allergic to an allergen. The method includes determining a dose of the allergen which causes a local inflammatory reaction on intact skin upon epicutaneous application. The allergen is applied to an intact region of the skin without an adjuvant so as to generate the local inflammatory reaction.

Repeated epicutaneous exposure is then performed by repeatedly applying the allergen, without an adjuvant, at a dose, frequency or for an application time adapted to sustain a local inflammatory reaction. The exposure and sustained reaction are stated to lead to desensitization of the subject while maintaining intact skin and avoiding adjuvants and skin pretreatment.

The allergen is stated to be applied by means of a cutaneous occlusive device configured to ensure contact between the allergen and the region of skin. The dose of allergen is comprised between 0.1 and 1,000 µg/cm2 of a surface area of the device, and device embodiments include occlusive patch devices with passive diffusion and at least partly transparent backing configured to allow viewing and threshold monitoring of cutaneous inflammation.

Claims Coverage

The independent claim presents four inventive features: dose determination for a local inflammatory reaction, adjuvant-free epicutaneous exposure on intact skin, repeated exposure adapted to sustain the reaction for desensitization, and delivery by a cutaneous occlusive device with a defined dose range per device surface area.

Dose determination for local inflammatory reaction on intact skin

Determining a dose of the allergen which causes a local inflammatory reaction on the skin of the subject upon epicutaneous application.

Adjuvant-free epicutaneous exposure to generate local inflammatory reaction

Epicutaneously exposing the subject to the allergen and generating the local inflammatory reaction in the subject by applying said dose of the allergen, without an adjuvant, on to an intact region of skin of the subject.

Repeated sustained inflammatory reaction leading to desensitization

Repeatedly applying the allergen, without an adjuvant, to an intact region of the skin of the subject, at a dose, frequency or for an application time adapted to sustain a local inflammatory reaction, the exposure and sustained reaction leading to desensitization of the subject.

Occlusive cutaneous device ensuring contact and defined dose per device surface area

Applying the allergen by means of a cutaneous occlusive device configured to ensure contact between the allergen and the region of skin, wherein said dose of allergen is comprised between 0.1 and 1,000 µg/cm2 of a surface area of the device.

Desensitization is linked to maintaining a local inflammatory reaction on intact skin through repeated, adjuvant-free epicutaneous allergen application, delivered via a cutaneous occlusive device with the specified dose range per device surface area.

Stated Advantages

Desensitization of the subject while applying the allergen without an adjuvant.

Sustaining a local inflammatory reaction on intact skin through repeated epicutaneous exposure, enabling desensitization.

Occlusive device contact between allergen and skin region and enabling viewing and threshold monitoring of cutaneous inflammation using at least partly transparent backing.

Documented Applications

Epicutaneous desensitization for allergens including pollen, ovalbumin, groundnuts proteins, and clinical cow’s milk case.

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