Phase 2
N=56
Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
Contact Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02028208 ↗Enrolled (actual)
56
Serious AEs
1.8%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration — 4; 0; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ammoniated mercury (Diagnostic_test); Aluminum chloride and aluminum lactate (Diagnostic_test); Sodium tetrachloropalladate (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Allerderm
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration |
4; 0; 0; 2; 2; 0 | — |
| SECONDARY Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application. |
17; 9; 21; 4; 2; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
1.15 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.
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.
Data sourced from ClinicalTrials.gov (NCT02028208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.