Contact dermatitis and metal hypersensitivity
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Pilot study group (Healthy volunteers) (N=15) • History taking gives no indication for further allergologic research • No metal implants • Patients must be willing to undergo routine diagnostics and cutaneous penetration tests by adhesive tape stripping;Full study enrolment group (N
Exclusion criteria
Exclusion criteria: All groups (pilot group & enrolment group & study groups) • Pregnancy or lactation • Age under 18 or above 70 • Legally incompetent adults • Topical treatment of immune suppressives on the back and arms within 7 days before performing patch tests and until finalization • Commercial skin lotions and ointments on the back and arms less than 8 hours before patch testing • Extensive UV exposure of the back and arms in the last 14 days before performing patch tests and until finalization • Usage of systemic immunosuppressive drugs (e.g. prednison, acitretine, adalimumab, efalizumab, etanercept, methoxsaleen, cyclosporine, azathioprine, infliximab and methothrexate) and antibiotics at least 2 weeks prior to starting of the study NB: Medication that reasonably not intervenes with the study procedures (e.g. an antihistaminicum can be used during the study) • Severe disorders within the last 6 month, e.g. cancer, acute cardiac- and circularity disorders, serious diabetics • Participation in a study with pharmaceutical within a period of at least 4 weeks prior to this study • Immunological disorders, e.g. HIV, infectious hepatitis • Alcohol and drug abuse • Extreme sports and heavy physical work, which are accompanied by strong sweating all over • Sauna during the study • Swimming during the study • Extreme shower-baths with wetting of the patch sites, from day 4 until day 6/7 careful showers are permitted • Negative control group volunteers may never have any positive patch test results or a history of eczema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are reactions on patch tests with current and novel titanium derivatives according to the International Contact Dermatitis Research Group (ICDRG) guidelines and the outcomes of the Lymphocyte Proliferation Test (in-vitro) and Lymphocyte Cytokine Production Test (in-vitro) for titanium allergy | — |
Secondary
| Measure | Time frame |
|---|---|
| - Reactions to patch tests with current and new titanium derivatives recorded by non-invasive optical techniques (photography / Sidestream darkfield imaging (SDF) / Optical Coherence Tomography Imaging (OCT)) and later validated by comparison with the primary outcome measures - Reactions to patch tests with irritants (irritability test) according to the recommendations of the Standardization Group of the European Society of Contact Dermatitis (ESCD). - Skin color of the test spots (after patch tests with irritants (irritabiliteits test)) measured with an DermaSpectrometer® (colorimeter) according to the guidelines of the ESCD for colorimetry - Transepidermal water loss (TEWL) at the of the test spots (after patch tests with irritants (irritabiliteits test)) measured with an TEWAmeter® (Evaporimeter) according to the guidelines of the ESCD on TEWL. | — |
Countries
Netherlands
Outcome results
None listed