Range-Finding and Pilot Study For: Extended Fragrance Ingredients Surveillance Study (EFISS) - Surveillance Study to Monitor the Frequency of Contact Allergy to a Defined Group of Fragrance Ingredients with a View to Providing Reliable Information on Trends

Range-Finding and Pilot Study For: Extended Fragrance Ingredients Surveillance Study (EFISS) - Surveillance Study to Monitor the Frequency of Contact Allergy to a Defined Group of Fragrance Ingredients with a View to Providing Reliable Information on Trends - Pilot study: Extended Fragrance Ingredients Surveillance Study (EFISS)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49753

Enrollment

Registered

2020-11-25

Start date

2022-04-21

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic contact dermatitis contact eczema

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Adulthood (>=18 years); 4 weeks before the day of application of the patch test - Legal competence

Exclusion criteria

Exclusion criteria: - Patients who have had topical steroids applied to their back less than 7 days before the application of the patch test. - Active skin disease or skin anomalies on the back - Immunosuppressive medication (e.g. oral cortosteroïds, methotrexate, cyclosporine) during or in the previous 4 weeks of the study; - pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
The results of the epicutaneous patch tests for the different concentrations of the fragrance materials according to the guidelines of the International Contact Dermatitis Research Group (ICDRG)	—

Secondary

Measure	Time frame
• Gain familiarisation with the additional materials • Test quality procedures designed to address intra- and inter centre variations • Test the CRF (Case Report Form: See Annex VI) and its administration	—

Countries

Netherlands

Outcome results