CompletedNot Applicable

Multi-Centre European Photopatch Test Study

United Kingdom1,000 participantsStarted 2008-07

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Within 72 hours of irradiation of patch test site

Trial details

NCT IDNCT00530387

SponsorNHS Tayside

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2011-07

View on ClinicalTrials.gov More Dermatitis, Photocontact trials