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Sponsored by: |
NHS Tayside |
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Information provided by: | NHS Tayside |
ClinicalTrials.gov Identifier: | NCT00530387 |
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.
Condition | Intervention |
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Dermatitis, Photocontact |
Drug: 19 organic sunscreen filters and 5 topical NSAIDs |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment |
Official 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. |
Estimated Enrollment: | 1000 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2009 |
Specific Intervention Names:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: James Ferguson, FRCP | +44 (0) 1382 632240 | j.ferguson@dundee.ac.uk |
Contact: Alastair C Kerr, MRCP | +44 (0) 1382 632240 | alikerr01@yahoo.co.uk |
United Kingdom, Angus | |
Photobiology Unit, Ninewells Hospital, | |
Dundee, Angus, United Kingdom, DD1 9SY |
Principal Investigator: | James Ferguson, FRCP | NHS Tayside |
Study ID Numbers: | 1-Kerr |
Study First Received: | September 13, 2007 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00530387 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee |
Photocontact Dermatitis NSAID Sunscreen Photopatch |
Ketoprofen Ibuprofen Benzophenone Skin Diseases Photosensitivity Disorders Salicylates Piroxicam Camphor Diclofenac |
Dermatitis, Contact Octylmethoxycinnamate Hypersensitivity Hypersensitivity, Delayed Dermatitis, Photoallergic Dermatitis, Allergic Contact Skin Diseases, Eczematous Dermatitis |
Radiation-Protective Agents Photosensitizing Agents Radiation-Sensitizing Agents Immune System Diseases Therapeutic Uses |
Physiological Effects of Drugs Sunscreening Agents Protective Agents Dermatologic Agents Pharmacologic Actions |