Multi-Centre European Photopatch Test Study

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.

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Photocontact
• Intervention / Treatment: Drug: 19 organic sunscreen filters and 5 topical NSAIDs

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 Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Angus
    • Dundee, Angus, United Kingdom, DD1 9SY
      • Photobiology Unit, Ninewells Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The development of a photocontact allergic skin response to sunscreen filters and topical NSAIDs, as graded by the ICDRG scale.	Within 72 hours of irradiation of patch test site

Collaborators and Investigators

• Sponsor: NHS Tayside
• Investigators: Principal Investigator: James Ferguson, FRCP, NHS Tayside

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: September 13, 2007
• First Submitted That Met QC Criteria: September 14, 2007
• First Posted (Estimate): September 17, 2007

Study Record Updates

• Last Update Posted (Estimate): August 4, 2011
• Last Update Submitted That Met QC Criteria: August 3, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: NSAID; Dermatitis; Sunscreen; Photocontact; Photopatch
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis, Contact; Photosensitivity Disorders; Dermatitis, Allergic Contact; Dermatitis; Dermatitis, Photoallergic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Protective Agents; Photosensitizing Agents; Dermatologic Agents; Radiation-Protective Agents; Diclofenac; Ibuprofen; Ketoprofen; Salicylates; Sunscreening Agents; Piroxicam; Benzophenone; Homosalate; Octylmethoxycinnamate; Etofenamate
• Other Study ID Numbers: 1-Kerr