Nickel Desensitization Using Topical Therapy

University of British Columbia24 enrolled

Overview

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.

Conditions

Allergic Contact Dermatitis

Interventions

Calcipotriol, Betamethasone, Calcipotriol & BetamethasoneDRUG

All study patients will be randomized to receive one of four topical ointments (calcipotriol, betamethasone dipropionate, combination of both calcipotriol/betamethasone dipropionate, or Vaseline petroleum jelly). Each subject will receive one unlabelled 5g tube for application to be dispensed by pharmacist, Rudy Chin. We expect approximately 2g of TOTAL use (0.125g applied twice daily over a 5 cm x 5 cm area on one forearm for 7 days). Typically, topical steroids such as betamethasone dipropionate have been used for treating a number of inflammatory skin conditions, including eczema. In addition, vitamin D analogues such as calcipotriol are used to treat psoriasis. Both agents, in our study, will be used on a small area of normal skin for a short 7 day course.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

UBC Contact Dermatitis Clinic

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Change in contact dermatitis response to nickel allergen at 5 weeks after topical desensitization

Erythema, induration, blistering of the skin will be noted. The standardized Likert scale (0-3+) will be used as follows: 1. \+ Weak (non-vesicular) reaction: erythema, infiltration, possibly papules 2. ++ Strong (edematous or vesicular) reaction 3. +++ Extreme (spreading, bullous or ulcerative) reaction * Negative reaction

Time frame: All study subjects will be evaluated after each patch test session (weeks 1, 3, 5). The final outcome to assess for desensitization will be evaluated at week 5.

Secondary Outcomes

Change in immune cell profile of patients 5 weeks after nickel desensitization

Peripheral T cells will be separated and responses will be determined by flow cytometry after nickel desensitization therapy. Approximately 50 ml of blood will be drawn from consenting subjects. Absolute cell numbers and immunophenotypes of cells will be reported.

Time frame: All consenting subjects will have baseline blood drawn at week 0 and again at week 5 to compare any differences in immune cells (ie. T cells).

Central Contacts

Gillian de Gannes, MD

CONTACT

604-731-5353 gdegannes@gmail.com

Data from ClinicalTrials.gov

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