Diagnosis of Allergic Contact Dermatitis MedDRA version: 20.0 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Ammoniated Mercury
Product Code: Panel 1
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: AMMONIO CLORURO
CAS Number: 10124-48-8
Current Sponsor code: Pannl 1
Other descriptiv
Sponsors
SMARTPRACTICE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. 18 years of age or older. b. History of contact dermatitis; c. Positive patch results to 1) mercury (elemental), 2) aluminum (aluminum chloride hexahydrate, aluminum hydroxide and/or aluminum lactate), 3) palladium (sodium tetrachloropalladate and/or palladium chloride), and/or 4) itching, subcutaneous nodules or excoriated papules at the sites of vaccination injections within the past 10 years; d. Unable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential; ¿ Inability to become pregnant would include all male subjects and female subjects who are postmenopausal for at least 1 year, or surgically sterile- have had a hysterectomy, bilateral ovariectomy, uterine ablation or bilateral tubal ligation. ¿ Acceptable methods of contraception include: 1) systemic birth control; 2) double barrier method (condom with spermicide or diaphragm with spermicide); 3) IUD; 4) vasectomized partner; or 5) abstinence from sexual intercourse. Subject must agree to use acceptable contraception for the duration of the entire study. e. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: a. Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant for the course of the study. b. Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 7 days prior to inclusion in this study. c. 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. d. Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion in this study. e. Acute dermatitis outbreak or dermatitis on or near the test area on the back. f. 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). g. 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. h. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the diagnostic performance and safety of mercury, aluminum and palladium proposed for inclusion in a T.R.U.E. TEST Metal Patch Test Panel.;Secondary Objective: No Secondary Objective;Primary end point(s): ¿Determination of optimal test allergen dose as the lowest concentration eliciting either 1+ or 2+ or 3+ positive reaction in 70-90% of subjects with the fewest number of 3+ reactions; ¿Overall concordance and discordance compared to the reference allergen. ¿The frequency of ranked skin responses- positive (1+, 2+, 3+); negative, doubtful and irritant reactions, will be calculated for each investigational and reference allergen dose tested. Statistical differences between the dose-related frequencies will be evaluated within each allergen using the Generalized Estimation Equations (GEE) approach, which is based on probability distributions. ¿Skin reaction concordance and discordance between the investigational allergen (mercury, aluminum and palladium) and the corresponding reference allergen will be determined in the total population tested. ¿The frequencies of positive skin reactions to the investigational allergens will be calculated by gender and race. ;Timepoint(s) of evaluation of this end point: Day 0-21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ¿ The frequencies (total and by scored character) of late reactions, persistent reactions, and tape irritation will be determined for the entire study population, and by gender and race. The frequencies of late reactions and persistent reactions will also be calculated according to allergen dose tested. ¿ The frequency of adverse events will be calculated for the entire study population, according to gender and race and to the allergen dose tested. ¿ Serious adverse events will be described in detailed case reports for each subject. ;Timepoint(s) of evaluation of this end point: Late or persistent reactions- days 4-21, tape irritation- day 2, adverse and serious events- days 2-21 | — |
Countries
Italy, Sweden
Contacts
Public ContactMichael Nielsen
SmartPractice Denmark
Outcome results
None listed