Multi-Centre European Photopatch Test Study - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Sun Exposure

Drug Information available for: Mexoryl SX Camphor

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Enrollment:	1000
Study Start Date:	July 2008
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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 %

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

Locations

United Kingdom
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

No publications provided

ClinicalTrials.gov Identifier:	NCT00530387 History of Changes
Other Study ID Numbers:	1-Kerr
Study First Received:	September 13, 2007
Last Updated:	August 3, 2011
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

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Photoallergic
Skin Diseases
Dermatitis, Allergic Contact
Dermatitis, Contact
Photosensitivity Disorders
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Benzophenone
Octylmethoxycinnamate
Oxybenzone

Sunscreening Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Photosensitizing Agents
Radiation-Sensitizing Agents
Dermatologic Agents
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012