Allergic Contact Dermatitis MedDRA version: 20.0 Level: SOC Classification code 10040785 Term: Skin and subcutaneous tissue disorders System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Aluminum chloride hexahydrate
Product Code: [Panel 1]
Pharmaceutical Form: Cutaneous paste
INN or Proposed INN: ALLUMINIO CLORURO
CAS Number: 7784-13-6
Current Sponsor code: Panel 1
Othe
Sponsors
SMARTPRACTICE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 18 years of age or older. 2) Past positive patch test result within the past 10 years (to one of the dilution series metals being tested on this study) or strong suspicion of metal contact allergy based on results of the Qualification Questionnaire. 3) 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; 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.) 4) Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations. 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 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1) Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant during the course of the study. 2) Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 14 days prior to inclusion through the end of this study. 3) Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents 14 days prior to inclusion through the end of the subject’s participation in the study. Inhaled treatments and steroidal nose or eye drops are permitted. 4) Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion through the end of this study. 5) Acute dermatitis outbreak or dermatitis on or near the test area on the back. 6) Known or suspected infection of the skin, joints or other site(s) associated with metal exposure 7) Conditions such as; fibromyalgia, chronic fatigue, depression, cognitive impairment, flu-like symptoms, diarrhea and/or headache without at least one of the symptoms related to metal exposure listed in Section 10.1 under physical examination 8) A condition such as; psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneous T-cell lymphoma that may confound the evaluation of allergic contact dermatitis. 9) 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). 10) Participation in a clinical trial of an investigational drug, treatment or device during this study or 3 weeks prior to inclusion in this study. 11) 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 metal allergens proposed for inclusion in Metal Panel T.R.U.E. Test. The study will compare the diagnostic performance (primary) and safety (secondary) of ascending patch test doses of aluminum, copper, manganese, molybdenum, tin, titanium, vanadium and zinc allergens.;Secondary Objective: To determine if subjects who have not had previous patch testing are allergic to any of the most common metal allergens; nickel, cobalt chromium and gold.;Primary end point(s): Determination of optimal test allergen dose will be based on the following criteria: The lowest concentration of each dilution series allergen eliciting positive responses in a minimum of 15 subjects. Positive responses (defined as score of 1+, 2+ or 3+ during at least one reaction assessment visit) may be due to the dilution series allergen, a corresponding reference allergen or both. If a significant number of 3+ responses are elicited, the dose will be selected based on 1+ and 2+ responses. Approximately 50% of the 15 positive responses attributed to a dilution series allergen, Moderate to very good concordance (measured using Cohen’s kappa, includes all subjects who test each allergen) between the dilution series and reference allergens. [less than 0% no agreement, 0-20% poor, 20-40% fair, 40-60% moderate, 60-80% good, 80% or higher very good].;Timepoint(s) of evaluation of this end point: Positive Responses are evaluated at 3-4, 7-8, 10-14 and 19-23 days after application of allergen patches. Concordance will be calculated at day 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Determination of allergen safety Frequency of tape and polyester chip induced irritation or allergic reactions at Visits 2 through 6. Frequency of subject reported sensations of itching and/or burning for each allergen panel at patch removal. Frequency of positive (1+, 2+, 3+) skin reactions for each investigational and reference allergen dose at each post removal visit and overall. Frequency of negative, doubtful, irritant, late and persistent skin reactions for each investigational and reference allergen dose at each post removal visit (late and persistent reactions at visits 4, 5 and 6 only). Frequency of all adverse events. Documentation for all local and systemic adverse reactions classified by the investigator as possibly or definitely related to the study product (e.g., erythema, hyper-pigmentation, hypo-pigmentation, skin thinning or dermatitis flare) will include grade (mild, moderate or severe) and time point (clinic visit). ;Timepoint(s) of evaluation of this end point: Tape and chip irritation is evaluated at 2, 3-4, 7-8, 10-14 and 19-23 days after application of allergen patches. Itching and burning are evaluated at 2 days after patch application. Skin reactions are evaluated at 3-4, 7-8, 10-14 and 19-23 days after application of allergen patches. Adverse events are evaluated at days 1-21. | — |
Countries
Germany, Italy, Japan, Switzerland, United States
Contacts
Public ContactMichael Nielsen
SmartPractice Denmark
Outcome results
None listed