Trials / Completed
CompletedNCT02615249
Clinical Evaluation of Metal Panel Allergens: Dose Response Study
Clinical Evaluation of Metal Panel Allergens: Aluminum, Copper, Manganese, Molybdenum, Tin, Titanium, Vanadium and Zinc Dose Response Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Allerderm · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
48-hour application of metal allergen patches to test for potential allergic responses.
Detailed description
A 48-hour application (approximate) of investigational allergen panels, excipient controls and corresponding reference allergens will be applied to the skin of human subjects to test for potential positive allergic responses. Test sites will be evaluated at 3-4, 7-8, 10-14 and 19-23 days after application. Ascending allergen dosages will be randomized within each panel into three different configurations which will be randomly assigned to subjects as they enter the study. The investigators and subjects will be aware of the allergens and the patch test doses but will not be aware of the location of individual allergens within each panel.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Metal Allergen Epicutaneous Patch | 48 hour application of metal allergen patch to diagnose contact dermatitis |
Timeline
- Start date
- 2016-12-05
- Primary completion
- 2019-07-15
- Completion
- 2019-07-15
- First posted
- 2015-11-26
- Last updated
- 2020-08-25
- Results posted
- 2020-08-11
Locations
8 sites across 6 countries: United States, Germany, Italy, Japan, Netherlands, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02615249. Inclusion in this directory is not an endorsement.