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

NCT02028208 | Completed Phase 2 Results

• 1 other identifier: SP12 2PM2 201
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Dermatitis

Keywords

Patch Test; Allergy Testing; Contact Dermatitis; Mercury, Aluminum or Palladium skin allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.

  Day 2: 48 hours after application

Study Arms (3)

Ammoniated mercury

EXPERIMENTAL

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.

Diagnostic Test: Ammoniated mercury

Aluminum chloride and aluminum lactate

EXPERIMENTAL

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.

Diagnostic Test: Aluminum chloride and aluminum lactate

Sodium tetrachloropalladaate (Palladium)

EXPERIMENTAL

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.

Diagnostic Test: Sodium tetrachloropalladate

Interventions

Ammoniated mercury DIAGNOSTIC_TEST

Metal allergen panel containing ascending doses of ammoniated mercury and a negative control.

Ammoniated mercury

Aluminum chloride and aluminum lactate DIAGNOSTIC_TEST

Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control.

Aluminum chloride and aluminum lactate

Sodium tetrachloropalladate DIAGNOSTIC_TEST

Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control.

Sodium tetrachloropalladaate (Palladium)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• \. History of contact dermatitis.
• \. 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.
• \. 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.
• \. 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.

You may not qualify if:

• Breastfeeding or pregnant or intending to become pregnant for the course of the 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).
• 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.

Sponsors & Collaborators

• Allerderm: lead

Study Sites (1)

Skane University Hospital Malmo

Malmo, SE-205 02, Sweden

Location

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Results Point of Contact

• Title: Kathryn Shannon
• Organization: Allerdern (dba) SmartPractice

kshannon@smarthealth.com

602 225 0595

Study Officials

• Marlene Isaksson, MD

  Skane University Hospital Malmo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Biologic

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 7, 2014
• Study Start: November 4, 2013
• Primary Completion: May 24, 2016
• Study Completion: May 24, 2016
• Last Updated: August 24, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-04

Locations

SE (1)