Multi-Centre European Photopatch Test Study

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.

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Key information

Conditions

Dermatitis, Photocontact Dermatitis Dermatitis, Allergic Contact Dermatitis, Contact Dermatitis, Photoallergic Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Photosensitivity Disorders Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Photobiology Unit, Ninewells Hospital,

Dundee, Angus, DD1 9SY, United Kingdom

About this study

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 %

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

19 organic sunscreen filters and 5 topical NSAIDs

Drug

Other 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 %

Primary outcomes

The development of a photocontact allergic skin response to sunscreen filters and topical NSAIDs, as graded by the ICDRG scale.

Time frame: Within 72 hours of irradiation of patch test site

Sponsors and collaborators

Lead sponsor

NHS Tayside

Other Gov

Registry information

Official study title

A Prospective, Open, Multi-Centre Photopatch Test Study of Patients Suspected of Photoallergy to Organic Sunscreens and Topical Nonsteroidal Anti-inflammatory Drugs Used Within Europe.

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Sep 17, 2007
Registry last updated: Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed