Back to resultsClinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
Primary Purpose
Contact Dermatitis
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Ammoniated mercury
Aluminum chloride and aluminum lactate
Sodium tetrachloropalladate
Sponsored by
About this trial
This is an interventional diagnostic trial for Contact Dermatitis focused on measuring Patch Test, Allergy Testing, Contact Dermatitis, Mercury, Aluminum or Palladium skin allergy
Eligibility 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:
- Breastfeeding or pregnant or intending to become pregnant for the course of the study.
- Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 7 days prior to inclusion in this study.
- 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.
- Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion in this study.
- Acute dermatitis outbreak or dermatitis on or near the test area on the back.
- 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).
- 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.
- 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.
Sites / Locations
- Skane University Hospital Malmo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Ammoniated mercury
Aluminum chloride and aluminum lactate
Sodium tetrachloropalladaate (Palladium)
Arm Description
Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.
Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.
Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.
Outcomes
Primary Outcome Measures
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Subjects were patch tested with 4 doses of mercury (0.00mg/cm2-neg control, 0.013 mg/cm2-dose 1, 0.040 mg/cm2-dose 2, 0.12 mg/cm2-dose 3 and 0.36 mg/cm2-dose 4) or 0 doses of aluminum (0.00 mg/cm2-neg control, 0.40 mg/cm2 aluminum chloride-dose 1, 0.12 mg/cm2 aluminum chloride-dose 2, 0.36 mg/cm2 aluminum chloride-dose 3 and 0.72 mg/cm2 aluminum chloride-dose 4, 0.047mg/cm2 aluminum lactate-dose 5, 0.14 mg/cm2 aluminum lactate-dose 6, 0.42 mg/cm2 aluminum lactate-dose 7, 0.84 mg/cm2 aluminum lactate-dose 8) or 5 doses of palladium (0.00 mg/cm2-neg control, 0.011 mg/cm2- dose 1, 0.033 mg/cm2- dose 2, 0.10 mg/cm2- dose 3, 0.30 mg/cm2- dose 4 and 0.60 mg/cm2- dose 5)..Skin reactions were assessed at 3, 4 and 21 days following application. A response is considered positive if it is graded 1+, 2+ or 3+during at least one post removal visit. Overall results are based on Investigator determination following the final study visit.
Secondary Outcome Measures
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02028208
Brief Title
Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
Official Title
Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 4, 2013 (Actual)
Primary Completion Date
May 24, 2016 (Actual)
Study Completion Date
May 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allerderm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the diagnostic performance and safety of ascending doses of mercury, aluminum and palladium metal allergens proposed for inclusion in a metal allergen panel. Optimal dose will be selected based on the lowest dose of each allergen eliciting a positive response in 70-90% of subjects tested.
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 had a past positive patch test to one of the allergens on this study. Investigators and subjects will be blinded to the exact location of each dose within the allergen panel but will not be blinded to the allergen being tested, nor the range of allergen doses within each panel.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis
Keywords
Patch Test, Allergy Testing, Contact Dermatitis, Mercury, Aluminum or Palladium skin allergy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Biologic
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ammoniated mercury
Arm Type
Experimental
Arm Description
Subjects will be patch tested with 4 experimental doses of ammoniated mercury, 0.013 mg/cm², 0.040 mg/cm², 0.12 mg/cm², and 0.36 mg/cm², a negative control and corresponding reference allergens, 1.0% ammoniated mercury in petrolatum and 0.5% elemental mercury in petrolatum. Patch tests will be worn for 48 hours.
Arm Title
Aluminum chloride and aluminum lactate
Arm Type
Experimental
Arm Description
Subjects will be patch tested with 4 experimental doses of aluminum chloride, 0.040 mg/cm², 0.12 mg/cm², 0.36 mg/cm² and 0.72 mg/cm², 4 experimental doses of aluminum lactate 0.047 mg/cm², 0.14 mg/cm², 0.42 mg/cm² and 0.84 mg/cm², a negative control and corresponding reference allergens, 2.0% aluminum chloride in petrolatum and 12.0% aluminum lactate in petrolatum. Patch tests will be worn for 48 hours.
Arm Title
Sodium tetrachloropalladaate (Palladium)
Arm Type
Experimental
Arm Description
Subjects will be patch tested with 5 experimental doses of sodium tetrachloropalladate 0.011 mg/cm², 0.033 mg/cm², 0.10 mg/cm², 0.30 mg/cm² and 0.60 mg/cm², a negative control and corresponding reference allergens, 3.0% sodium tetrachloropalladate in petrolatum and 1.0% palladium chloride 1.0% in petrolatum. Patch tests will be worn for 48 hours.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ammoniated mercury
Intervention Description
Metal allergen panel containing ascending doses of ammoniated mercury and a negative control.
Intervention Type
Diagnostic Test
Intervention Name(s)
Aluminum chloride and aluminum lactate
Intervention Description
Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sodium tetrachloropalladate
Intervention Description
Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control.
Primary Outcome Measure Information:
Title
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
Description
Subjects were patch tested with 4 doses of mercury (0.00mg/cm2-neg control, 0.013 mg/cm2-dose 1, 0.040 mg/cm2-dose 2, 0.12 mg/cm2-dose 3 and 0.36 mg/cm2-dose 4) or 0 doses of aluminum (0.00 mg/cm2-neg control, 0.40 mg/cm2 aluminum chloride-dose 1, 0.12 mg/cm2 aluminum chloride-dose 2, 0.36 mg/cm2 aluminum chloride-dose 3 and 0.72 mg/cm2 aluminum chloride-dose 4, 0.047mg/cm2 aluminum lactate-dose 5, 0.14 mg/cm2 aluminum lactate-dose 6, 0.42 mg/cm2 aluminum lactate-dose 7, 0.84 mg/cm2 aluminum lactate-dose 8) or 5 doses of palladium (0.00 mg/cm2-neg control, 0.011 mg/cm2- dose 1, 0.033 mg/cm2- dose 2, 0.10 mg/cm2- dose 3, 0.30 mg/cm2- dose 4 and 0.60 mg/cm2- dose 5)..Skin reactions were assessed at 3, 4 and 21 days following application. A response is considered positive if it is graded 1+, 2+ or 3+during at least one post removal visit. Overall results are based on Investigator determination following the final study visit.
Time Frame
Patch test sites were evaluated at days 3, 7, 10, 14, and 21 days after application. Results are based on Investigator's review of reactions following the day 21 evaluation
Secondary Outcome Measure Information:
Title
Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.
Description
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.
Time Frame
Day 2: 48 hours after application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Breastfeeding or pregnant or intending to become pregnant for the course of the study.
Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 7 days prior to inclusion in this study.
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.
Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion in this study.
Acute dermatitis outbreak or dermatitis on or near the test area on the back.
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).
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene Isaksson, MD
Organizational Affiliation
Skane University Hospital Malmo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skane University Hospital Malmo
City
Malmo
ZIP/Postal Code
SE-205 02
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
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