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Multi-Centre European Photopatch Test Study
This study is not yet open for participant recruitment.
Verified by NHS Tayside, May 2008
Sponsored by: NHS Tayside
Information provided by: NHS Tayside
ClinicalTrials.gov Identifier: NCT00530387
  Purpose

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
Dermatitis, Photocontact
Drug: 19 organic sunscreen filters and 5 topical NSAIDs

Drug Information available for: Ibuprofen Dexibuprofen Ketoprofen Diclofenac Diclofenac potassium Diclofenac sodium Piroxicam Mexoryl SX Camphor Benzophenone-3 Isoamyl p-methoxycinnamate
U.S. FDA Resources
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.

Further study details as provided by NHS Tayside:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: July 2008
Estimated Study Completion Date: July 2009
Detailed 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 %
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530387

Contacts
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

Locations
United Kingdom, Angus
Photobiology Unit, Ninewells Hospital,
Dundee, Angus, United Kingdom, DD1 9SY
Sponsors and Collaborators
NHS Tayside
Investigators
Principal Investigator: James Ferguson, FRCP NHS Tayside
  More Information

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

Keywords provided by NHS Tayside:
Photocontact
Dermatitis
NSAID
Sunscreen
Photopatch

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009