Study on the Safety and Effectiveness of Metal Panel Allergens for Patients with Allergic Contact Dermatitis
- Participants:Adults · Healthy volunteers
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Kalium bichromicum is a homeopathic preparation of potassium dichromate, a chemical compound containing chromium. In the clinical trial records, it appears as Kaliumdichromat 0.5% in a test ointment (Testsalbe) used for patch testing. The substance is classified as a homeopathic product and is not an authorised medicine in the conventional sense. A product label from Bestmade Natural Products describes Kali Bichromicum as an unapproved homeopathic remedy marketed for sinus health support, runny nose, ropy discharges, and localized discomfort.[2]
The same substance appears under the name Kaliumdichromat in the trial interventions. The homeopathic product label states that the product has not been evaluated by the FDA for safety or efficacy, and that the FDA is not aware of scientific evidence to support homeopathy as effective.[2]
In the context of patch testing, Kaliumdichromat serves as a diagnostic allergen. Patch testing places small amounts of potential allergens on the skin under occlusion to see whether a local allergic reaction develops, which helps identify the cause of allergic contact dermatitis. The trial does not describe a molecular mechanism of action for kalium bichromicum itself; its role is diagnostic rather than therapeutic.[1]
As a homeopathic preparation, the product label describes a traditional homeopathic practice basis and states that it does not claim to diagnose, treat, cure, or prevent any disease. The label provides no pharmacological mechanism of action.[2]
The homeopathic product label mentions support for sinus health, runny nose, ropy discharges, and localized discomfort, but these are not studied in the registered clinical trial.[2]
In the clinical trial, Kaliumdichromat 0.5% is applied to the skin as a test ointment (Testsalbe) in a volume of 20 microlitres for cutaneous use during patch testing.[1][1] The trial compares two delivery forms: a hydrogel investigational allergen and a petrolatum reference allergen.[1]
As a homeopathic product, the label describes soluble tablets taken with water 3 to 4 times a day, with 5 pellets for ages 12 or older, 3 pellets for ages 2 to 12, and consultation with a doctor for children below 2 years of age.[2]
The registry contains two records for the same trial identifier, NCT04500834, titled "Metal Panel Patch Test." One record is authorised and lists 395 participants; the other was withdrawn and listed 300 participants.[1][1] Both records describe a Phase 3 interventional study.
The trial evaluates the diagnostic efficacy and safety of investigational allergens, including Kaliumdichromat 0.5%, and the overall safety and performance of the investigational panel device. The primary outcome measures the concordance, or agreement, between the hydrogel and petrolatum patch testing methods using Cohen's kappa calculation and positive and negative percent agreement.[1][1]
The trial includes a panel of metal allergens: nickel sulfate, copper sulfate, tin chloride, manganese chloride, ammonium titanium oxide oxalate, zinc chloride, gold sodium thiosulfate, sodium tetrachloropalladate, cobalt chloride, vanadium oxide sulfate, and Kaliumdichromat 0.5%.[1]
Because the trial is a patch test study, participants are people with suspected allergic contact dermatitis who need diagnostic testing to identify metal allergies. The records do not list detailed eligibility criteria beyond the condition studied.[1][1]
The homeopathic product label warns to keep the product away from children and to discontinue use if any reaction occurs that is not positive. It does not list specific side effects.[2] The clinical trial records do not report side effect data, as the study evaluates safety as part of its objectives without listing specific adverse events in the registry.[1]
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