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Nickel Desensitization Using Topical Therapy

This study is not yet open for participant recruitment.
Verified August 2011 by University of British Columbia
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01413477
First received: April 13, 2011
Last updated: August 8, 2011
Last verified: August 2011
History of Changes

April 13, 2011
August 8, 2011
August 2011
February 2012   (final data collection date for primary outcome measure)
Change in contact dermatitis response to nickel allergen at 5 weeks after topical desensitization [ 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. ] [ Designated as safety issue: No ]

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
Same as current
Complete list of historical versions of study NCT01413477 on ClinicalTrials.gov Archive Site
Change in immune cell profile of patients 5 weeks after nickel desensitization [ 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). ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Nickel Desensitization Using Topical Therapy
Nickel Desensitization Using Topical Therapy

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Contact Dermatitis
Drug: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone
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.
Other Names:
  • Dovonex (calcipotriol ointment, DIN 01976133 Leo Pharma),
  • Dovobet (DIN 02244126, Leo Pharma)
  • Betamethasone diproprionate (0.5% ointment USP generic)
  • Active Comparator: Calcipotriol ointment
    Intervention: Drug: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone
  • Active Comparator: Betamethasone dipropionate ointment
    Intervention: Drug: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone
  • Active Comparator: Calcipotriol and betamethasone ointment
    Intervention: Drug: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone
  • Placebo Comparator: Vaseline Petroleum Jelly
    Intervention: Drug: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
24
June 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact: Gillian de Gannes, MD 604-731-5353 gdegannes@gmail.com
Canada
 
NCT01413477
H10-02854
No
Jan P. Dutz, University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Jan P Dutz, MD University of British Columbia
University of British Columbia
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP