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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
  Purpose

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.


Condition Intervention
Allergic Contact Dermatitis
 Drug: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nickel Desensitization Using Topical Therapy

Resource links provided by NLM:

MedlinePlus related topics: Allergy Vitamin D
U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 24
Study Start Date: August 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Calcipotriol ointment 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: Betamethasone dipropionate ointment 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 and betamethasone ointment 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)
Placebo Comparator: Vaseline Petroleum Jelly 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)

Detailed 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.
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413477

Contacts
Contact: Gillian de Gannes, MD 604-731-5353 gdegannes@gmail.com

Locations
Canada, British Columbia
UBC Contact Dermatitis Clinic Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 3Y1
Contact: Gillian de Gannes, MD     604-731-5353     gdegannes@gmail.com    
Sub-Investigator: Gillian de Gannes, MD            
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Jan P Dutz, MD University of British Columbia
  More Information

Publications:

Responsible Party: Jan P. Dutz, University of British Columbia
ClinicalTrials.gov Identifier: NCT01413477     History of Changes
Other Study ID Numbers: H10-02854
Study First Received: April 13, 2011
Last Updated: August 8, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Allergic contact dermatitis
Nickel allergy
Desensitization therapy

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Nickel
Calcitriol
Petrolatum
Calcipotriene
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances
Emollients
Dermatologic Agents
Vitamins

ClinicalTrials.gov processed this record on June 17, 2013