Multi-Centre European Photopatch Test Study

This study has been completed.
Sponsor:
Information provided by:
NHS Tayside
ClinicalTrials.gov Identifier:
NCT00530387
First received: September 13, 2007
Last updated: August 3, 2011
Last verified: July 2011
  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:


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:
    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 %
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dermatitis, Allergic Contact
Dermatitis, Contact
Hypersensitivity
Hypersensitivity, Delayed
Immune System Diseases
Photosensitivity Disorders
Skin Diseases
Skin Diseases, Eczematous
Anti-Inflammatory Agents, Non-Steroidal
Benzophenone
Octylmethoxycinnamate
Sunscreening Agents
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Radiation-Sensitizing Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014