Clinical trial • Phase III • Dermatology
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|Eczema
Phase III trial of COPPER SULPHATE, ANHYDROUS; STANNOUS CHLORIDE DIHYDRATE; ZINC CHLORIDE; COBALT CHLORIDE; GOLD SODIUM THIOSULFATE; SODIUM TETRACHLOROPAL…
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Allergic contact dermatitis|Eczema
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-09-2023
- First CTIS Authorization Date
- 19-01-2024
Trial design
Randomised, open-label, comparators include: kaliumdichromat (potassium dichromate) 0.5% ointment; kobaltchlorid (cobalt chloride) 1% ointment; nickel(ii)-sulfat 5% ointment; tin allergen (stannous chloride 1%) cutaneous patch; gold allergen (gold sodium thiosulfate) 2.0% cutaneous patch; sodium allergen (sodium tetrachloropalladate) 3% cutaneous patch; copper allergen (copper sulfate pentahydrate) 2% cutaneous patch; ammonium allergen (ammonium titanium oxide oxalate) 21% cutaneous patch; manganese allergen (manganese chloride tetrahydrate) 2% cutaneous patch; vanadium allergen (vanadium oxide sulfate) 1.3% cutaneous patch; zinc allergen (zinc chloride) 1% cutaneous patch. dose percentages/formulations are provided where stated; schedule not specified.-controlled Phase III trial in Germany, Italy, Netherlands.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Comparators include: Kaliumdichromat (Potassium dichromate) 0.5% ointment; Kobaltchlorid (Cobalt chloride) 1% ointment; Nickel(II)-sulfat 5% ointment; Tin Allergen (stannous chloride 1%) cutaneous patch; Gold Allergen (gold sodium thiosulfate) 2.0% cutaneous patch; Sodium Allergen (sodium tetrachloropalladate) 3% cutaneous patch; Copper Allergen (copper sulfate pentahydrate) 2% cutaneous patch; Ammonium Allergen (ammonium titanium oxide oxalate) 21% cutaneous patch; Manganese Allergen (manganese chloride tetrahydrate) 2% cutaneous patch; Vanadium Allergen (vanadium oxide sulfate) 1.3% cutaneous patch; Zinc Allergen (zinc chloride) 1% cutaneous patch. Dose percentages/formulations are provided where stated; schedule not specified.
- Target Sample Size
- 195
Eligibility
Recruits 195 Vulnerable population not selected. Participants must "Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations". No assent process described..
- Pregnancy Exclusion
- b. Breastfeeding 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
- Vulnerable Population
- Vulnerable population not selected. Participants must "Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations". No assent process described.
Inclusion criteria
- {"criterion_text":"- a.\t18 years of age or older\n- 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.\n- c.\tGroup 2 only: No past or current body piercings, dental appliances, braces, fillings, implants, prosthesis or restorations, surgical hardware, orthopedic implants or cardiac implants.\n- d.\tGroup 2 only: No routine occupational or long term exposure to metals\n- e.\tUnable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential\n- 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.\n- 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).\n- 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.\n- 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.\n- m.\tAlcohol abuse as well as drug and/or medication abuse. GERMANY ONLY\n- n.\tSevere psychiatric, psychological or neurological disorders. GERMANY ONLY\n- o.\tPatients in any relationship or dependency with the sponsor and/or investigator. GERMNY ONLY\n- p.\tGeneral inflammatory as well severe acute and chronic inflammatory diseases. GERMANY ONLY\n- q.\tMalignancy during the previous 5 years. GERMANY ONLY\n- r.\tCompleted or ongoing long-term treatment with tranquilizer or psycho active drug.\n- 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\n- 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.\n- 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.\n- 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.\n- f.\tAcute dermatitis outbreak or dermatitis on or near the test area on the back.\n- g.\tKnown or suspected infection of the skin, joints or other site(s) associated with metal exposure\n- 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.\n- i.\tCondition such as, psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneous T-cell lymphoma that may confound the evaluation of allergic contact dermatitis."}
Endpoints
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":"Agreement measured using Cohen's kappa calculation and by positive and negative percent agreement between hydrogel (investigational allergen) and petrolatum (reference allergen) patch testing methods."}
Secondary endpoints
- {"endpoint_text":"- Measures of allergen safety and performance of device constituent.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 195
- Recruitment Window Months
- 23
- Consent Approach
- Informed consent: participants must "Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations". No assent process described. No languages or multi-language consent forms specified.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 105
Germany
- Earliest CTIS Part Ii Submission Date
- 22-11-2023
- Latest Decision Or Authorization Date
- 22-01-2024
- Processing Time Days
- 61
- Number Of Sites
- 2
- Number Of Participants
- 30
Sites
- Site Name
- Ludwig Maximilian University Of Munich
- Department Name
- Clinic and Polyclinic for Dematology and Allergology Institute
- Contact Person Name
- Eva Oppel
- Contact Person Email
- eva.oppel@med.uni-muenchen.de
- Site Name
- Ludwig Maximilian University Of Munich
- Department Name
- Clinic and Polyclinic for Dematology and Allergology Institute
- Contact Person Name
- Burkhard Summer
- Contact Person Email
- burkhard.summer@med.uni-muenchen.de
Italy
- Earliest CTIS Part Ii Submission Date
- 08-12-2023
- Latest Decision Or Authorization Date
- 19-01-2024
- Processing Time Days
- 42
- Number Of Sites
- 2
- Number Of Participants
- 45
Sites
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Dermatological Institute of Policlinical Hospital, University of Milan
- Contact Person Name
- Silvia Ferrucci
- Contact Person Email
- silvia.ferrucci@policlinico.mi.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- Department of Medicine and Surgery - University of Perugia, Italy
- Contact Person Name
- Luca Stingeni
- Contact Person Email
- luca.stingeni@unipg.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 27-11-2023
- Latest Decision Or Authorization Date
- 19-01-2024
- Processing Time Days
- 53
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Amsterdam UMC
- Department Name
- Department of Dermatology
- Contact Person Name
- Thomas Rustemeyer
- Contact Person Email
- t.rustemeyer@amsterdamumc.nl
Sponsor
Primary sponsor
- Full Name
- Smarthealth Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Metal Panel Allergens
- Active Substance
- 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
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 1
- Maximum Dose
- 0.49 mg
- Investigational Product Name
- Kaliumdichromat 0,5%, Testsalbe
- Active Substance
- KALIUM BICHROMICUM
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 2
- Maximum Dose
- 20 µl
- Investigational Product Name
- Kobaltchlorid 1%, Testsalbe
- Active Substance
- COBALT CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 2
- Maximum Dose
- 20 µl
- Investigational Product Name
- Nickel(II)-sulfat, 6*H2O 5%, Testsalbe
- Active Substance
- NICKEL SULFATE HEXAHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 2
- Maximum Dose
- 20 µl
- Investigational Product Name
- Copper Allergen (copper sulfate pentahydrate 2%)
- Active Substance
- COPPER SULPHATE, ANHYDROUS
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 1
- Maximum Dose
- 20 µl
- Investigational Product Name
- Tin Allergen (stannous chloride 1%)
- Active Substance
- STANNOUS CHLORIDE DIHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 1
- Maximum Dose
- 20 µl
- Investigational Product Name
- Gold Allergen (gold sodium thiosulfate (GST) 2.0%)
- Active Substance
- GOLD SODIUM THIOSULFATE
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 1
- Maximum Dose
- 20 µl
- Investigational Product Name
- Sodium Allergen (sodium tetrachloropalladate 3%)
- Active Substance
- SODIUM TETRACHLOROPALLADATE
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 1
- Maximum Dose
- 20 µl
- Investigational Product Name
- Ammonium Allergen (ammonium titanium oxide oxalate 21%)
- Active Substance
- AMMONIUM TITANIUM OXALATE MONOHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 1
- Maximum Dose
- 20 µl
- Investigational Product Name
- Manganese Allergen (manganese chloride tetrahydrate 2%)
- Active Substance
- MANGANESE CHLORIDE TETRAHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 1
- Maximum Dose
- 20 µl
- Investigational Product Name
- Vanadium Allergen (vanadium oxide sulfate 1.3%)
- Active Substance
- VANADIUM OXIDE SULFATE
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 1
- Maximum Dose
- 20 µl
- Investigational Product Name
- Zinc Allergen (zinc chloride 1%)
- Active Substance
- ZINC CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- 1
- Maximum Dose
- 20 µl
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