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

NCT ID: NCT02028208

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-04
• Study Completion Date: 2016-05-24

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.

Conditions

Contact Dermatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ammoniated mercury

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.

Group Type: EXPERIMENTAL

Ammoniated mercury

Intervention Type: DIAGNOSTIC_TEST

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

Aluminum chloride and aluminum lactate

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.

Group Type: EXPERIMENTAL

Aluminum chloride and aluminum lactate

Intervention Type: DIAGNOSTIC_TEST

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

Sodium tetrachloropalladaate (Palladium)

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.

Group Type: EXPERIMENTAL

Sodium tetrachloropalladate

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Ammoniated mercury

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

Intervention Type: DIAGNOSTIC_TEST

Aluminum chloride and aluminum lactate

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

Intervention Type: DIAGNOSTIC_TEST

Sodium tetrachloropalladate

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

Intervention Type: DIAGNOSTIC_TEST

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

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allerderm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marlene Isaksson, MD

Role: PRINCIPAL_INVESTIGATOR

Skane University Hospital Malmo

Locations

Skane University Hospital Malmo

Malmo, , Sweden

Countries

Sweden

Other Identifiers

SP12 2PM2 201

Identifier Type: -

Identifier Source: org_study_id