Multi-Centre European Photopatch Test Study

NHS Tayside

Status

Completed

Conditions

Dermatitis, Photocontact

Treatments

Drug: 19 organic sunscreen filters and 5 topical NSAIDs

Study type

Interventional

Funder types

Other

Identifiers

NCT00530387

1-Kerr

Details and patient eligibility

About

It is known that people can develop an allergic skin reaction to a substance which is placed on the skin and then subjected to sunlight. This process is called Photocontact allergic dermatitis. It is known that people can develop Photocontact allergic dermatitis to sunscreen chemicals (filters) and also cream forms of pain-killing drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).

The purpose of this study is to determine the frequency of Photocontact allergic dermatitis to 19 sunscreen filters and 5 topical NSAIDs in 1,000 European patients who present to a dermatologist with a sun-exposed site dermatitis.

Each participant will have the 24 test agents plus one control of petrolatum applied to the skin of the back for 24 or 48 hours. After removal of the substances, the area of skin will be exposed to a precise amount of ultraviolet-A light. The area is then assessed 24, 48 and 72 hours later to see if a photocontact allergic reaction has occured. This method is known as photopatch testing.

The study will run for one year, during which time it is planned to recruit 1,000 patients.

Full description

Specific Intervention Names:

Butyl-methoxy-dibenzoylmethane
Homosalate
Methylbenzylidene camphor
Benzophenone-3
Octyl methoxycinnamate
Phenylbenzimidazol sulfonic acid
Benzophenone 4
Drometrizole trisiloxane
Octocrylene
Octyl salicylate
Octyl triazone
Isoamyl-p-methoxycinnamate
Terephtalidene dicamphor sulphonic acid (Mexoryl SX)
Tinosorb S
Tinosorb M
Univul A+
Neoheliopan AP
Uvasorb HEB
Parsol SLX
Ketoprofen 1%
Etofenamate 2%
Piroxicam 1%
Diclofenac 5%
Ibuprofen 5 %

Enrollment

1,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female aged 18 years or older.
Have sufficient cognitive capacity to give written informed consent.
Have an eruption on photo-exposed sites, which is to be further classified using one (or more) of the categories below:
Known photosensitivity disease
History of sunscreen reaction
Sun exposed site dermatitis during summer months
Any sun exposed site dermatitis problem

Exclusion criteria

Male or female aged 17 years or younger
Have had potent topical steroid applied to the photopatch test site on the back in the previous 5 days. (This potentially suppresses reactions which would otherwise have been visible)
Have skin disease on the back which is too active to allow testing. (This obscures the sites of testing by making differentiation between a positive result and other skin disease difficult)
Be prescribed systemic immunosuppressant medication (e.g. prednisolone, methotrexate, azathioprine, ciclosporin) (This potentially suppresses reactions which would otherwise have been visible)
Be taking any photoactive medicine (for example thiazides, sulphonamide derivatives, amiodarone, fluoroquinolones, chlorpromazine, NSAIDs, quinine). (This is a relative exclusion. Many centres may wish to go ahead despite such medication).