Allergic Contact Dermatitis Due to Nickel Clinical Trial
Official title:
Evaluation of the Clinical Implication of Short Repeated Nickel Exposures
| Verified date | February 2020 |
| Source | Herlev and Gentofte Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 became a part of REACH (the EU chemicals regulation) in 2009. Since then the
prevalence of nickel allergy has declined in some countries, but not in others, following the
implementation. Young individuals still become allergic to nickel (2, 3) and a high
prevalence of nickel allergy, exceeding 10%, is seen among young women (below 30 years) in
the general population.
The EU nickel regulation has been changing over time. The present limits of nickel release
for metallic items intended for direct and prolonged contact with the skin is <0.5
μg/cm2/week and <0.2 μg/cm2/week for any post assemblies inserted into pierced holes. In
2014, EU defined prolonged contact with the skin as: at least 30 minutes on one or more
occasions within two weeks for items with continuous skin contact, or to at least 10 minutes
on three or more occasions within two weeks (7).
The overall objective is to evaluate how well the EU nickel regulation protects individuals
against developing nickel dermatitis. More specifically we will:
1. Study the penetration of nickel in normal and irritated skin after short repeated skin
exposure under controlled temperature in nickel sensitized patients and in healthy
controls
2. Reveal the potential of short repeated nickel skin exposure on normal and irritated skin
to elicit dermatitis, during controlled climate factors in nickel sensitized patients
and controls using the time restrictions of the definition of prolonged skin contact in
the nickel regulation.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | December 10, 2017 |
| Est. primary completion date | December 10, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
For patients with nickel allergy: Inclusion Criteria: - 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 Criteria: - 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. Exclusion Criteria: - History of contact allergy - 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 four 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Allergy and Dermatology | Hellerup |
| Lead Sponsor | Collaborator |
|---|---|
| Herlev and Gentofte Hospital | Karolinska Institutet |
Denmark,
Emilson A, Lindberg M, Forslind B. The temperature effect on in vitro penetration of sodium lauryl sulfate and nickel chloride through human skin. Acta Derm Venereol. 1993 Jun;73(3):203-7. — View Citation
Erfani B, Lidén C, Midander K. Short and frequent skin contact with nickel. Contact Dermatitis. 2015 Oct;73(4):222-30. doi: 10.1111/cod.12426. Epub 2015 Jun 18. — View Citation
Fullerton A, Hoelgaard A. Binding of nickel to human epidermis in vitro. Br J Dermatol. 1988 Nov;119(5):675-82. — View Citation
Hostýnek JJ, Dreher F, Nakada T, Schwindt D, Anigbogu A, Maibach HI. Human stratum corneum adsorption of nickel salts. Investigation of depth profiles by tape stripping in vivo. Acta Derm Venereol Suppl (Stockh). 2001;(212):11-8. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical evaluation of development of dermatitis after stimulation over time | Development of dermatitis after stimulation with nickel discs as a change from baseline skin assessment. The criteria developed by the International Contact Dermatitis Research Group (ICDRG), later modified by Hindsén and Bruze will be used for assessment | 24 hours and 78 hours post stimulation with nickel discs | |
| Primary | Change of baseline blood flow over time after stimulation | measure blood flow with laser doppler technique as a surrogate for inflammation on skin following stimulation with nickel discs over time | 24 hours and 78 hours post stimulation with nickel discs | |
| Primary | Nickel skin penetration at different time points after stimulation | by using the tape stripping technique we will measure the deposition of nickel and the penetration of nickel in the stratum corneum following stimulation | Immediate deposition and penetration, 24 hours and 78 hours post stimulation of nickel discs |