Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing – Diagnostic or test agent produces visible change on skin
Patent
1998-03-17
1999-08-17
Saunders, David
Drug, bio-affecting and body treating compositions
In vivo diagnosis or in vivo testing
Diagnostic or test agent produces visible change on skin
A61K 4900
Patent
active
059390468
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to a method for evaluating an effect of a substance on the immune response of the skin of a mammal. The method may be used to provide information which can be shown on commercial preparations of substances so that consumers are better able to make a comparison between such substances. The invention also relates to the substance evaluated by the method.
BACKGROUND ART
Exposure to UV radiation can cause erythema (sunburn), the formation of DNX pyrimidine dimers, premature ageing and dermal connective tissue changes. It is common to evaluate the protection from erythema provided by a sunscreen preparation by determining its sunscreen protection factor (SPF). The practice, of determining SPF is useful not only in providing information as to the effectiveness of different sunscreen preparations in protecting against erythema, but also in the determination of a minimum level of protection which must be met before a given sunscreen preparation can be marketed commercially.
Studies have shown that exposure to ultraviolet radiation can also profoundly impair the cutaneous immunity of mammals and it is widely believed that ultraviolet radiation induced immunosuppression contributes significantly to cutaneous carcinogenesis.
The effects of UV radiation on the immune system include reduced contact hypersensitivity (CHS) and delayed hypersensitivity reactions, systemic immunosuppression in mice, and tolerance of tumours in mice or Cestari 1995, Cooper 1992!. In humans, such alterations in immunity can occur even with small, suberythemal doses of UV.
Where cutaneous immunity is markedly affected by long-term, systemic immunosuppressive medications, as is seen in transplant recipients, the incidence of non-melanoma skin cancer is ten to one hundred-fold higher Espana 1995!.
It is, therefore, important that human beings who are exposed to even small doses of UV radiation be protected not only from the erythemal and mutagenic effects of sunlight, but also from its immunosuppressive effects. While sunscreens can decrease the formation of pyrimidine DNA skin cancer in humans, if they fail to protect the immune system then individuals using high SPF sunscreens who tend to stay in the sun for extended periods may become severely immunosuppressed and have an increased risk of skin malignancy. prevented UV suppression of induction of primary contact sensitisation to dinitrochloroberizene (DNCB). Work in mice suggests that UV immunoprotection is more dependent on broad spectrum cover than SPF probably different.
Previous studies of UV suppression of CHS have used induction of primary CHS to antigens such as DNCB. However, since induction of primary CHS requires exposure to an antigen for the first time the immune response to the antigen cannot be anticipated and it is possible the exposure may elicit a severe response which is, of course, undesirable.
Induction of primary CHS to an antigen also necessarily means that the resultant immune response may only be evaluated once in a given subject. Accordingly, in order to evaluate the ability of a substance to suppress a skin immune response or to evaluate the protection provided by the substance against suppression of the immune response by ultraviolet radiation using induction of primary CHS, a large number of different individuals are required. This is also undesirable and is compounded by the need to use different groups of individuals each time a substance is evaluated.
With the increasing availability of high SPF sunscreens, such as SPF 30, which encourages individuals to stay in the sun for substantial periods of time, there is a need for a reliable and relatively convenient method for evaluating the amount of immunoprotection afforded by commonly used sunscreen ingredients and sunscreens in general. Similarly, there is a need for a suitable and effective method for evaluating whether the cutaneous immunity of an individual is impaired by a substance when applied to the individual's skin.
DISCLOSURE OF INVENTION
In a first as
REFERENCES:
patent: 5302389 (1994-04-01), Kripke et al.
Bestak et al, Jour. Invest. Dermatol., 105, 345-351, 1995.
Hersey et al, Jour. Invest. Dermatol., 88, 271-276, 1987.
Reeve et al, Jour. Invest. Dermatol., 97, 624-628, 1991.
Roberts et al, Jour. Invest. Dermatol., 105, 339-344, 1995.
Whitmore et al, Arch. Dermatol., 131, 1128-1133, 1995.
Wolf et al, Jour. Invest Dermatol., 100, 254-259, 1993.
Barnetson Ross St. C.
Damian Diona L.
Halliday Gary M.
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