Status:
COMPLETED
Short Repeated Nickel Exposures
Lead Sponsor:
Herlev and Gentofte Hospital
Collaborating Sponsors:
Karolinska Institutet
Conditions:
Allergic Contact Dermatitis Due to Nickel
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The former Nickel Directive was introduced in EU in 1994 limiting the release of nickel from items intended for prolonged contact with skin. The nickel regulation entered into full force in 2001 and b...
Eligibility Criteria
Inclusion
- For patients with nickel allergy:
- Positive patch test to nickel sulphate 5% pet. according to European society of contact dermatitis(ESCD) guidelines within the last 5 years at the Department of Dermatology and Allergy, Gentofte Hospital.
- Age 18-75 years.
Exclusion
- Active eczema in test areas
- Generalized eczema
- Scar tissue in test areas.
- Pregnancy or breast feeding
- Treatment with topical corticosteroids or other immune-suppressants on/near test areas within four weeks prior to study start
- Systemic immunomodulatory\* treatment within 4 weeks prior to study start
- UV exposure of test areas within three weeks prior to study start
- Participation in other clinical studies within four weeks prior to study start
- Unable to cooperate or communicate with the investigators \*Systemic immunomodulatory treatment is drugs taken orally or by injection that modify the response of the immune system by increasing (immunostimulators) or decreasing (immunosuppressives) the production of serum antibodies
- For Healthy volunteers:
- Inclusion Criteria:
- Negative patch test result to nickel sulphate 5% pet. according to ESCD guidelines (48) at the Department of Dermatology and Allergy, Gentofte Hospital
- Age 18-75 years.
Key Trial Info
Start Date :
September 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03309215
Start Date
September 16 2017
End Date
December 10 2017
Last Update
February 11 2020
Active Locations (1)
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1
Department of Allergy and Dermatology
Hellerup, Denmark, 2900