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Multi-Centre European Photopatch Test Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00530387
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : August 4, 2011
Sponsor:
Information provided by:
NHS Tayside

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Dermatitis, Photocontact Drug: 19 organic sunscreen filters and 5 topical NSAIDs Not Applicable

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 %
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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.
Study Start Date : July 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sun Exposure

Arms and Interventions
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Intervention Details:
  • Drug: 19 organic sunscreen filters and 5 topical NSAIDs
    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 %

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530387


Locations
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United Kingdom
Photobiology Unit, Ninewells Hospital,
Dundee, Angus, United Kingdom, DD1 9SY
Sponsors and Collaborators
NHS Tayside
Investigators
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Principal Investigator: James Ferguson, FRCP NHS Tayside
More Information
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ClinicalTrials.gov Identifier: NCT00530387    
Other Study ID Numbers: 1-Kerr
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: July 2011
Keywords provided by NHS Tayside:
Photocontact
Dermatitis
NSAID
Sunscreen
Photopatch
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Photoallergic
Skin Diseases
Dermatitis, Allergic Contact
Dermatitis, Contact
Photosensitivity Disorders
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Ibuprofen
Diclofenac
Ketoprofen
Piroxicam
Salicylates
 Etofenamate
Sunscreening Agents
Homosalate
Octylmethoxycinnamate
Benzophenone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors