COPPER SULPHATE, ANHYDROUS; STANNOUS CHLORIDE DIHYDRATE; ZINC CHLORIDE; COBALT CHLORIDE; GOLD SODIUM THIOSULFATE; SODIUM TETRACHLOROPALLADATE; VANADIUM OXIDE SULFATE; AMMONIUM TITANIUM OXALATE MONOHYDRATE; NICKEL SULFATE; MANGANESE CHLORIDE TETRAHYDRATE; KALIUM BICHROMICUM for Allergic contact dermatitis

Inclusion criteria

• {"criterion_text":"- a.\t18 years of age or older"}
• {"criterion_text":"- b.\tGroup 1: Active dermatitis that is suspected to be allergic contact dermatitis to one or more of the metal panel allergens or a recent history (within the past 5 years) of dermatitis that is suspected to be due to metal allergy, and that resolved prior to enrollment due to treatment or elimination of exposure to the suspected metal trigger. Population may include individuals with suspected allergic contact dermatitis due to a positive patch test within the preceding 10 years and/or a metal implant. Group 2: No history or symptoms of dermatitis related skin disease."}
• {"criterion_text":"- c.\tGroup 2 only: No past or current body piercings, dental appliances, fillings, implants, prosthesis or restorations, surgical hardware, orthopedic implants or cardiac implants."}
• {"criterion_text":"- d.\tGroup 2 only: No routine occupational or long term exposure to metals"}
• {"criterion_text":"- e.\tUnable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential"}
• {"criterion_text":"- f.\tUnderstands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations"}

Exclusion criteria

• {"criterion_text":"- a.\tParticipation in Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study, SP12 2PM2 201, or Clinical Evaluation of Metal Panel Allergens: Aluminum, Copper, Manganese, Molybdenum, Tin, Titanium, Vanadium and Zinc Dose Response Study, SP14 8MP 201."}
• {"criterion_text":"- j.\tInability 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)."}
• {"criterion_text":"- k.\tParticipation in a clinical trial of an investigational drug, treatment or device during this study or 3 weeks prior to inclusion in this study."}
• {"criterion_text":"- l.\tAn 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."}
• {"criterion_text":"- m.\tGERMANY ONLY: Alcohol abuse as well as drug and/or medication abuse."}
• {"criterion_text":"- n.\tGERMANY ONLY: Severe psychiatric, psychological or neurological disorders."}
• {"criterion_text":"- o.\tGERMANY ONLY: Patients in any relationship or dependency with the sponsor and/or investigator."}
• {"criterion_text":"- p.\tGERMANY ONLY: General inflammatory as well severe acute and chronic inflammatory diseases. GERMANY ONLY"}
• {"criterion_text":"- q.\tGERMANY ONLY: Malignancy during the previous 5 years. GERMANY ONLY"}
• {"criterion_text":"- r.\tGERMANY ONLY: Completed or ongoing long-term treatment with tranquilizer or psycho active drug."}
• {"criterion_text":"- b.\tBreastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant during the course of the study. Breastfeeding may be resumed upon completion of the study"}
• {"criterion_text":"- c.\tTopical treatment with corticosteroids or other immunosuppressive agents on or near the test area 14 days prior to inclusion through the end of the subject’s participation in the study."}
• {"criterion_text":"- d.\tSystemic 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."}
• {"criterion_text":"- e.\tTreatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion through the end of the subject’s participation in the study."}
• {"criterion_text":"- f.\tAcute dermatitis outbreak or dermatitis on or near the test area on the back."}
• {"criterion_text":"- g.\tKnown or suspected infection of the skin, joints or other site(s) associated with metal exposure"}
• {"criterion_text":"- h.\tCondition 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 6.6."}
• {"criterion_text":"- i.\tCondition such as, psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneous T-cell lymphoma that may confound the evaluation of allergic contact dermatitis."}

Primary endpoints

• {"endpoint_text":"- Concordance (agreement) between the hydrogel (investigational allergen) and petrolatum (reference allergen) patch testing methods using Cohen’s kappa calculation and by positive and negative percent agreement.","definition_or_measurement_approach":"Measured using Cohen’s kappa calculation and by positive and negative percent agreement comparing hydrogel (investigational allergen) versus petrolatum (reference allergen) patch test methods."}

Secondary endpoints

• {"endpoint_text":"- Measures of allergen safety and performance of device constituent.","definition_or_measurement_approach":"Assessment of allergen safety and performance of the device constituent; specific measures not detailed in the available record."}

Germany

Earliest CTIS Part Ii Submission Date

27-03-2024

Latest Decision Or Authorization Date

01-11-2024

Processing Time Days

219

Number Of Sites

2

Number Of Participants

30

Netherlands

Earliest CTIS Part Ii Submission Date

21-05-2024

Latest Decision Or Authorization Date

04-11-2024

Processing Time Days

167

Number Of Sites

1

Number Of Participants

20

Italy

Earliest CTIS Part Ii Submission Date

27-03-2024

Latest Decision Or Authorization Date

10-02-2025

Processing Time Days

320

Number Of Sites

2

Number Of Participants

45

Primary sponsor

Full Name

Smarthealth Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Third parties

• {"country":"","full_name":"SmartPractice","duties_or_roles":"Monetary support","organisation_type":""}