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Multi-Centre European Photopatch Test Study

Primary Purpose

Dermatitis, Photocontact

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

19 organic sunscreen filters and 5 topical NSAIDs

About this trial

This is an interventional diagnostic trial for Dermatitis, Photocontact focused on measuring Photocontact, Dermatitis, NSAID, Sunscreen, Photopatch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Photobiology Unit, Ninewells Hospital,

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00530387

First Posted

September 13, 2007

Last Updated

August 3, 2011

Sponsor

NHS Tayside

1. Study Identification

Unique Protocol Identification Number

NCT00530387

Brief Title

Multi-Centre European Photopatch Test Study

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 Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

NHS Tayside

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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 %

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Photocontact

Keywords

Photocontact, Dermatitis, NSAID, Sunscreen, Photopatch

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1000 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

19 organic sunscreen filters and 5 topical NSAIDs

Other Intervention Name(s)

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 %

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Ferguson, FRCP

Organizational Affiliation

NHS Tayside

Official's Role

Principal Investigator

Facility Information:

Facility Name

Photobiology Unit, Ninewells Hospital,

City

Dundee

State/Province

Angus

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

12. IPD Sharing Statement

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Multi-Centre European Photopatch Test Study

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