Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
The purpose of this study is to compare ascending doses of investigational T.R.U.E. Test allergens to the marketed petrolatum reference allergen.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
|Official Title:||Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study|
- Percentage of Participants who exhibit Positive Responses to each Allergen Concentration [ Time Frame: 3-21 days following application ] [ Designated as safety issue: No ]Subjects will be patch tested with one experimental T.R.U.E. Test allergen panel containing ascending doses of either mercury, aluminum or palladium and a negative control and a second panel containing the marketed reference allergen. The panels will be worn for approximately 48 hours. Skin reactions will be assessed at 3, 4 and 21 days following application. A response is considered positive if it is graded 1+ (erythema, infiltration, discrete papules), 2+ (erythema, papules, infiltration, discrete vesicles) or 3+ (coalescing vesicles, bullous eruption) during at least one post removal visit.
- Percentage of Participants who exhibit Irritation (tape reaction), Itching and/or Burning Resulting from Application of the Investigational and Reference Allergen Panels [ Time Frame: Day 2: 48 hours after application ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Mercury, Aluminum or Palladium Subjects
Subjects will be patch tested with ascending doses of mercury, aluminum or palladium and a negative control and a second panel containing the marketed reference allergen. The panels will be worn for approximately 48 hours. Skin reactions will be assessed at 3, 4 and 21 days following application.
Biological: Mercury, Aluminum, Palladium
T.R.U.E. Test metal allergen panels containing ascending doses of mercury, aluminum or palladium
Other Name: T.R.U.E. Test Mercury, Aluminum or Palladium Allergen Panel
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 tested positive (current or previous patch test) to at least one of the allergens being tested.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02028208
|Contact: Marlene Isaksson, MDfirstname.lastname@example.org|
|Contact: Magnus Bruze, MDemail@example.com|
|Skane University Hospital Malmo||Recruiting|
|Malmo, Sweden, SE-205 02|
|Contact: Marlene Isaksson, MD|
|Contact: Magnus Bruze, MD|
|Principal Investigator: Marlene Isaksson, MD|
|Principal Investigator:||Marlene Isaksson, MD||Skane University Hospital Malmo|