Photopatch Test Study (POST Study)

NCT03812887 | Unknown DMC

• 1 other identifier: MaterMUH
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

In the year 2000, a group of specialists with an interest in contact dermatitis and photobiology/photophysics set up a taskforce under the umbrella of the European Society for Contact Dermatitis and the European Society for Photodermatology. This came about as a result of an awareness, that photopatch testing was under-used, there were inconsistencies in methodology and scoring of results, and there was a lack of up-to-date choice of test photoallergens. A consensus on the methodology of photopatch testing arose from this, although some inconsistencies on the methodology could not be solved and variations on the technique were accepted. Since then a European multicentre photopatch test study (EMCPPTS) was conducted in 30 clinics from 2008-2011. The EMCPPTS test agents comprised 19 UV absorbers, and 5 topical non-steroidal anti-inflammatory drugs available in Europe. More than 1,000 patients took part in this study that showed that ketoprofen and related chemicals and classical UV-filters were the main photoallergens. Since then the taskforce have met again (2012) and on the basis of the results of the ECMPPTS, on previous publications reporting cases of photoallergic contact dermatitis, and on the presence or absence of these agents in consumer products within the European market or other accessible markets, 20 substances were chosen to form the baseline European photopatch test series. Fifteen additional substances were chosen to be included in the extended photopatch test series which may be used as an additional screen alongside patients' own product. Twenty-six other agents that are no longer produced or are no longer used in the European markets have been considered to be no longer relevant for regular photopatch testing and were removed. It was suggested from this taskforce that the study should be repeated in approximately five years, as it is expected that new photoallergens will continue to emerge despite pre-marketing screening measures. Therefore members of this taskforce subsequently met in 2015, to discuss the aim of performing a very similar study, commencing in 2016. However, the investigators aim to focus specifically on methodology as in all previous studies a variety of methods of photopatch testing have been utilised. The investigators therefore aim to improve standardisation of this test. This agreed methodology will therefore enable better comparative studies in the future and hopefully encourage greater numbers of would-be users of this form of patch testing, as due to a previous level of uncertainty, many general dermatologists have been discouraged from using this technique.

Conditions

Photoallergy

Outcome Measures

Primary Outcomes (1)

• Record the frequency of photoallergic and allergic reactions to the most recently recommended battery of allergens used in photopatch testing in Europe

  Photopatchtesting to the most up to date Sunscreen series and extended series

  Two years

Secondary Outcomes (1)

• Compare within the same individual, photopatch tests results when the tests are irradiated at 24hr or 48hr in order to ascertain whether one or other time point is superior with respect to pick-up of relevant positive photoallergic reactions.

  Two years

Interventions

Photopatchtesting DIAGNOSTIC_TEST

Photopatchtesting to the sunscreen series and extended series, irradiated at both 24 and 48 hours

Also known as: Patchtesting

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients attending the dermatology clinics for photopatch testing will be offerred inclusion into the study

You may qualify if:

• Aged 18 years and over
• Referred for photodiagnostic testing or for patch testing for investigation of any of the following indications:
• Exposed-site dermatitis in summer months Any exposed site dermatitis History of reaction to sunscreen/NSAID or related agents Suspected or confirmed photosensitivity
• Able to understand and comply with the restrictions and requirements of the study
• Able to provide written informed consent

You may not qualify if:

• Unable to understand and comply with the restrictions and requirements of the study
• Not able to give written informed consent
• Recent sunburn/tan on back within 4 weeks of the planned photopatch testing
• Systemic immunosuppressants, including oral corticosteroids (\>10mg/day)
• Active skin disease on back precluding testing.
• Potent topical corticosteroid use to back within 5 days of planned recruitment and testing
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Mater Misericordiae University Hospital: lead
• European Association of Dermatology and Venerology: collaborator

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, 7, Ireland

RECRUITING

MeSH Terms

Conditions

Dermatitis, Photoallergic

Condition Hierarchy (Ancestors)

Dermatitis, Allergic Contact; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Photosensitivity Disorders; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Central Study Contacts

Nicola E Ralph, MB BCh BAO MRCPI

CONTACT

0035318032000; nralph@mater.ie

Kelsey O Donnell, NMBI

CONTACT

003538032000; kodonnell@mater.ie

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 23, 2019
• Study Start: September 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: January 1, 2021
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)