Nickel Desensitization Using Topical Therapy

University of British Columbia

Status: Unknown

Conditions: Allergic Contact Dermatitis

Treatments: Drug: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01413477

H10-02854

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

Calcipotriol ointment

Active Comparator group

Treatment:

Drug: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone

Betamethasone dipropionate ointment

Active Comparator group

Treatment:

Drug: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone

Calcipotriol and betamethasone ointment

Active Comparator group

Treatment:

Drug: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone

Vaseline Petroleum Jelly

Placebo Comparator group

Treatment:

Drug: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone