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Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Allerderm
Sponsor:
Information provided by (Responsible Party):
Allerderm
ClinicalTrials.gov Identifier:
NCT02028208
First received: January 2, 2014
Last updated: September 22, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to compare ascending doses of investigational T.R.U.E. Test allergens to the marketed petrolatum reference allergen.


Condition Intervention Phase
Contact Dermatitis
Biological: Mercury, Aluminum, Palladium
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study

Resource links provided by NLM:


Further study details as provided by Allerderm:

Primary Outcome Measures:
  • Percentage of Participants who exhibit Positive Responses to each Allergen Concentration [ Time Frame: 3-21 days following application ] [ Designated as safety issue: No ]
    Subjects will be patch tested with one experimental T.R.U.E. Test allergen panel containing ascending doses of either mercury, aluminum or palladium and a negative control and a second panel containing the marketed reference allergen. The panels will be worn for approximately 48 hours. Skin reactions will be assessed at 3, 4 and 21 days following application. A response is considered positive if it is graded 1+ (erythema, infiltration, discrete papules), 2+ (erythema, papules, infiltration, discrete vesicles) or 3+ (coalescing vesicles, bullous eruption) during at least one post removal visit.


Secondary Outcome Measures:
  • Percentage of Participants who exhibit Irritation (tape reaction), Itching and/or Burning Resulting from Application of the Investigational and Reference Allergen Panels [ Time Frame: Day 2: 48 hours after application ] [ Designated as safety issue: Yes ]

    Tape irritation is graded on a 4 point scale: None (no tape irritation), Weak (faint to definite pink), Moderate (moderate erythema, definite redness) and Strong (severe erythema, very intense redness). Percentage of response will include weak, moderate and strong reactions.

    Itching and Burning are graded on a 4 point scale: None (no discomfort), Weak (minimal discomfort), Moderate (definite discomfort) and Strong (significantly bothersome, possible interference with sleep or daily activity). Percentage of response will include weak, moderate and strong responses.



Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mercury, Aluminum or Palladium Subjects
Subjects will be patch tested with ascending doses of mercury, aluminum or palladium and a negative control and a second panel containing the marketed reference allergen. The panels will be worn for approximately 48 hours. Skin reactions will be assessed at 3, 4 and 21 days following application.
Biological: Mercury, Aluminum, Palladium
T.R.U.E. Test metal allergen panels containing ascending doses of mercury, aluminum or palladium
Other Name: T.R.U.E. Test Mercury, Aluminum or Palladium Allergen Panel

Detailed Description:

This is a single-center, double-blind, randomized study to compare the diagnostic performance (primary) and safety (secondary) of ascending doses of mercury, aluminum and palladium in 20 adult subjects who have a clinical history of contact dermatitis and have tested positive (current or previous patch test) to at least one of the allergens being tested.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.15 years of age or older.

2. History of contact dermatitis.

3. Positive patch results to 1) mercury (elemental), 2) aluminum (aluminum chloride hexahydrate, aluminum hydroxide and/or aluminum lactate) or 3) palladium (sodium tetrachloropalladate and/or palladium chloride) within the past 10 years.

4. Male or non-pregnant non-lactating female. Female subjects must state, at visit one that they are not pregnant, not lactating nor are they intending to become pregnant for the course of the study.

5. Has understood and signed the approved Informed Consent/Assent Form, which is consistent with all institutional, local and national regulations. Assent Form for all minor subjects (ages 15-17) must be signed by the guardian/parent.

Exclusion Criteria:

  1. Breastfeeding or pregnant or intending to become pregnant for the course of the study.
  2. Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 7 days prior to inclusion in this study.
  3. Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents during the 7 days prior to inclusion in this study. Inhaled treatments are permitted.
  4. Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion in this study.
  5. Acute dermatitis outbreak or dermatitis on or near the test area on the back.
  6. Inability to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
  7. Participation in a clinical trial of an investigational drug, treatment or device other than T.R.U.E. TEST during this study or 3 weeks prior to inclusion in this study.
  8. An opinion of the Investigator that deems the potential subject to be non-compliant, unable to return for study visits or complete the study as detailed in the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028208

Contacts
Contact: Marlene Isaksson, MD marlene.isaksson@skane.se
Contact: Magnus Bruze, MD magnus.bruze@med.lu.se

Locations
Sweden
Skane University Hospital Malmo Recruiting
Malmo, Sweden, SE-205 02
Contact: Marlene Isaksson, MD         
Contact: Magnus Bruze, MD         
Principal Investigator: Marlene Isaksson, MD         
Sponsors and Collaborators
Allerderm
Investigators
Principal Investigator: Marlene Isaksson, MD Skane University Hospital Malmo
  More Information

No publications provided

Responsible Party: Allerderm
ClinicalTrials.gov Identifier: NCT02028208     History of Changes
Other Study ID Numbers: SP12 2PM2 201
Study First Received: January 2, 2014
Last Updated: September 22, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by Allerderm:
Patch Test
Allergy Testing
Contact Dermatitis
Mercury, Aluminum or Palladium skin allergy

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on November 25, 2014