Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
|ClinicalTrials.gov Identifier: NCT02028208|
Recruitment Status : Unknown
Verified January 2014 by Allerderm.
Recruitment status was: Recruiting
First Posted : January 7, 2014
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Contact Dermatitis||Biological: Mercury, Aluminum, Palladium||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2015|
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
- Percentage of Participants who exhibit Positive Responses to each Allergen Concentration [ Time Frame: 3-21 days following application ]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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028208
|Contact: Marlene Isaksson, MDemail@example.com|
|Contact: Magnus Bruze, MDfirstname.lastname@example.org|
|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|