Nickel Desensitization Using Topical Therapy
1 other identifier
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedAugust 10, 2011
August 1, 2011
6 months
April 13, 2011
August 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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 (1)
Change in immune cell profile of patients 5 weeks after nickel desensitization
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).
Study Arms (4)
Calcipotriol ointment
ACTIVE COMPARATORBetamethasone dipropionate ointment
ACTIVE COMPARATORCalcipotriol and betamethasone ointment
ACTIVE COMPARATORVaseline Petroleum Jelly
PLACEBO COMPARATORInterventions
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 Criteria
You may qualify if:
- Age \> 18 years.
- Patients have had a diagnosis of nickel allergy determined by patch testing
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UBC Contact Dermatitis Clinic
Vancouver, British Columbia, V5Z 3Y1, Canada
Related Publications (10)
Ghoreishi M, Bach P, Obst J, Komba M, Fleet JC, Dutz JP. Expansion of antigen-specific regulatory T cells with the topical vitamin d analog calcipotriol. J Immunol. 2009 May 15;182(10):6071-8. doi: 10.4049/jimmunol.0804064.
PMID: 19414758BACKGROUNDLandeck L, Schalock PC, Baden LA, Neumann K, Gonzalez E. Patch-testing with the standard series at the massachusetts general hospital, 1998 to 2006. Dermatitis. 2009 Mar-Apr;20(2):89-94.
PMID: 19426614BACKGROUNDJacob SE, Moennich JN, McKean BA, Zirwas MJ, Taylor JS. Nickel allergy in the United States: a public health issue in need of a "nickel directive". J Am Acad Dermatol. 2009 Jun;60(6):1067-9. doi: 10.1016/j.jaad.2008.11.893. Epub 2009 Jan 23. No abstract available.
PMID: 19167779BACKGROUNDThyssen JP, Linneberg A, Menne T, Johansen JD. The epidemiology of contact allergy in the general population--prevalence and main findings. Contact Dermatitis. 2007 Nov;57(5):287-99. doi: 10.1111/j.1600-0536.2007.01220.x.
PMID: 17937743BACKGROUNDHanneman KK, Scull HM, Cooper KD, Baron ED. Effect of topical vitamin D analogue on in vivo contact sensitization. Arch Dermatol. 2006 Oct;142(10):1332-4. doi: 10.1001/archderm.142.10.1332.
PMID: 17043189BACKGROUNDMoed H, von Blomberg BM, Bruynzeel DP, Scheper RJ, Gibbs S, Rustemeyer T. Regulation of nickel-induced T-cell responsiveness by CD4+CD25+ cells in contact allergic patients and healthy individuals. Contact Dermatitis. 2005 Aug;53(2):71-4. doi: 10.1111/j.0105-1873.2005.00635.x.
PMID: 16033398BACKGROUNDWu X, Roelofs-Haarhuis K, Zhang J, Nowak M, Layland L, Jermann E, Gleichmann E. Dose dependence of oral tolerance to nickel. Int Immunol. 2007 Aug;19(8):965-75. doi: 10.1093/intimm/dxm066. Epub 2007 Aug 13.
PMID: 17698564BACKGROUNDCavani A, Nasorri F, Ottaviani C, Sebastiani S, De Pita O, Girolomoni G. Human CD25+ regulatory T cells maintain immune tolerance to nickel in healthy, nonallergic individuals. J Immunol. 2003 Dec 1;171(11):5760-8. doi: 10.4049/jimmunol.171.11.5760.
PMID: 14634084BACKGROUNDKang Y, Xu L, Wang B, Chen A, Zheng G. Cutting edge: Immunosuppressant as adjuvant for tolerogenic immunization. J Immunol. 2008 Apr 15;180(8):5172-6. doi: 10.4049/jimmunol.180.8.5172.
PMID: 18390698BACKGROUNDZaunders JJ, Munier ML, Seddiki N, Pett S, Ip S, Bailey M, Xu Y, Brown K, Dyer WB, Kim M, de Rose R, Kent SJ, Jiang L, Breit SN, Emery S, Cunningham AL, Cooper DA, Kelleher AD. High levels of human antigen-specific CD4+ T cells in peripheral blood revealed by stimulated coexpression of CD25 and CD134 (OX40). J Immunol. 2009 Aug 15;183(4):2827-36. doi: 10.4049/jimmunol.0803548. Epub 2009 Jul 27.
PMID: 19635903BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan P Dutz, MD
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 13, 2011
First Posted
August 10, 2011
Study Start
August 1, 2011
Primary Completion
February 1, 2012
Study Completion
June 1, 2012
Last Updated
August 10, 2011
Record last verified: 2011-08