nickel desensitization using topical therapy

Conditions: Allergic Contact Dermatitis

Summary: nickel contact dermatitis (eczema) is one of the most common allergic conditions affecting the skin. this is a study looking at potentially desensitizing nickel-allergic patients to their allergy using anti-inflammatory ointments applied to the skin (arm). application of these ointments (ie. modified vitamin d) has been shown to increase specific immune cells (t regulatory cells), which play a role in preventing immune activation and subsequently inflammation. the investigators propose use of topical anti-inflammatory agents (corticosteroids, modified vitamin d, or both) may desensitize patients with nickel allergy.

1. purpose: to evaluate whether topical anti-inflammatory ointments (calcipotriol, betamethasone dipropionate, or a combination of both) can decrease sensitivity to nickel in known nickel allergic patients. optional blood samples will be part of the protocol to measure immune responses. 2. hypothesis: use of these topical agents will prevent sensitization to nickel sulfate upon re-exposure. 3. justification: currently, no cure can yet be offered to nickel sensitive patients. standard treatment only involves avoiding nickel-containing products. however, this is not always easily achieved depending on patient awareness and environmental exposures. topical desensitization has not yet been explored in patients with pre-established contact allergy. this research will be placebo-controlled with vaseline petroleum jelly to compare reactions to nickel in those treated with anti-inflammatory ointments. 4. objectives: a) to evaluate the use of topical anti-inflammatory agents and its role in desensitizing known nickel allergic patients to nickel. b) to measure immune cell responses to nickel allergen from a blood sample taken before and after topical anti-inflammatory application. 5. research method: randomized, double-blinded, placebo-controlled, proof of principle study. subjects meeting inclusion and exclusion criteria with known nickel sensitivity will be recruited into the study. those who consent will undergo 3 sets of nickel patch testing: at week 1 to confirm nickel allergic status, week 3 to induce tolerance by patch testing at the site of topical ointment application, and finally at week 5 to test for desensitization. (week 2 is self-application with topical ointment; week 4 is a rest week). 6. statistical analysis: a) primary end-point: clinical responses measured by standard patch testing scores will be documented and photographed for comparison. b) secondary end-point: levels of t regulatory cell responses before and after topical treatment. c) planned sample size: 24 patients. given that this is a proof-of-principle study, the investigators are choosing to study a small sample size to detect any differences amongst treatment arms, if any. a larger-scale, adequately-powered study would be needed to detect any statistical significance.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * patients have had a diagnosis of nickel allergy determined by patch testing exclusion criteria: * treatment with immunomodulating medications concurrently or in the previous one month * active skin disease, particularly to the site of application (forearms) * hypersensitivity to calcipotriol, corticosteroids, or vehicle * previous anaphylactic reactions to nickel allergen * pregnancy or breast-feeding

Keywords: allergic contact dermatitis nickel allergy desensitization therapy