Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
Verified January 2014 by Allerderm
Information provided by (Responsible Party):
First received: January 2, 2014
Last updated: September 22, 2014
Last verified: January 2014
The purpose of this study is to compare ascending doses of investigational T.R.U.E. Test allergens to the marketed petrolatum reference allergen.
Biological: Mercury, Aluminum, Palladium
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
||Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2015 (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.
|Ages Eligible for Study:
||15 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02028208
|Skane University Hospital Malmo
|Malmo, Sweden, SE-205 02 |
|Contact: Marlene Isaksson, MD |
|Contact: Magnus Bruze, MD |
|Principal Investigator: Marlene Isaksson, MD |
||Marlene Isaksson, MD
||Skane University Hospital Malmo
No publications provided
History of Changes
|Other Study ID Numbers:
||SP12 2PM2 201
|Study First Received:
||January 2, 2014
||September 22, 2014
||Sweden: Medical Products Agency
Keywords provided by Allerderm:
Mercury, Aluminum or Palladium skin allergy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2015
Skin Diseases, Eczematous