Dermatitis, PhotocontactNCT00530387
Multi-Centre European Photopatch Test Study
A study testing 19 organic sunscreen filters and 5 topical NSAIDs in people with Dermatitis, Photocontact, run by NHS Tayside at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Photocontact
- What is being tested?
- 19 organic sunscreen filters and 5 topical NSAIDs
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Photobiology Unit, Ninewells Hospital,
Dundee, Angus, DD1 9SY
About this 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.
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.
Read more
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.
Read the 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 %
- Conditions
- Dermatitis, Photocontact
- Being tested
- 19 organic sunscreen filters and 5 topical NSAIDs
- Keywords
- Photocontact, Dermatitis, NSAID, Sunscreen, Photopatch
- Medical subject headings
- Dermatitis, Photoallergic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19 organic sunscreen filters and 5 topical NSAIDsDrug
Also called Butyl-methoxy-dibenzoylmethane, Homosalate, Methylbenzylidene camphor, Benzophenone-3
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of a photocontact allergic skin response to sunscreen filters and topical NSAIDs, as graded by the ICDRG scale.
Measured: Within 72 hours of irradiation of patch test site
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startJul 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, PhotocontactStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Investigators
- James Ferguson, FRCP, Principal investigator, NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530387
- Sponsor's protocol ID
- 1-Kerr
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2007
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00530387
- Acronym / sponsor ID
- 1-Kerr
- Conditions
- Dermatitis, Photocontact
- Keywords
- Photocontact, Dermatitis, NSAID, Sunscreen, Photopatch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Study start
- Jul 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 %
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 19 organic sunscreen filters and 5 topical NSAIDsAlso: Butyl-methoxy-dibenzoylmethane, Homosalate, Methylbenzylidene camphor, Benzophenone-3 | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Ferguson, FRCP principal investigator
NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 19 organic sunscreen filters and 5 topical NSAIDs in people with Dermatitis, Photocontact, run by NHS Tayside at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2011.