Multi-Centre European Photopatch Test Study
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| ClinicalTrials.gov Identifier: NCT00530387 |
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Recruitment Status :
Completed
First Posted : September 17, 2007
Last Update Posted : August 4, 2011
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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 |
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 (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 |
- 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 %
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
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
| United Kingdom | |
| Photobiology Unit, Ninewells Hospital, | |
| Dundee, Angus, United Kingdom, DD1 9SY | |
| Principal Investigator: | James Ferguson, FRCP | NHS Tayside |
| ClinicalTrials.gov Identifier: | NCT00530387 History of Changes |
| 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:
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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 Sunscreening Agents Octylmethoxycinnamate Anti-Inflammatory Agents, Non-Steroidal |
Benzophenone Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Dermatologic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Photosensitizing Agents |