Study on the Safety and Effectiveness of Metal Panel Allergens for Patients with Allergic Contact Dermatitis
- Participants:Adults · Healthy volunteers
Rare diseases
Investigational molecules
Locations
Stannous chloride dihydrate is a tin salt. In the clinical trial records, it appears under the name "Tin Allergen (stannous chloride 1%)" and is used as a diagnostic allergen for patch testing.[1][1] The substance is chemically related to stannous fluoride, a tin compound with the formula 2 F.Sn, which is listed in the FDA's Unique Ingredient Identifier (UNII) system under the code 3FTR44B32Q.[3] Stannous fluoride is an ingredient in a kit for preparing technetium Tc 99m medronate, a diagnostic imaging agent.[2]
In patch testing, small amounts of metal allergens are applied to the skin to see whether an allergic reaction develops. The mechanism relies on the immune system recognising the metal as a foreign substance and mounting a local skin response. The trial records do not describe a specific molecular target for stannous chloride dihydrate.[1][1] The related compound stannous fluoride acts as a reducing agent in diagnostic kits, helping to bind technetium Tc 99m to medronic acid for bone imaging.[2]
In the clinical trial, stannous chloride dihydrate is prepared as a 1% test preparation and applied to the skin, described in the registry as "cutaneous use".[1][1] A volume of 20 microlitres is used for each patch test application.[1][1] The related compound stannous fluoride is available as a lyophilised powder for solution in a diagnostic kit for intravenous injection after preparation.[2]
The registry lists two records of the same phase 3 interventional study titled "Metal Panel Patch Test". One record is withdrawn with 300 planned participants and lists both allergic contact dermatitis and eczema as conditions.[1] The other record is authorised with 395 participants and lists allergic contact dermatitis.[1] The primary outcome in both records is the concordance, or agreement, between the hydrogel investigational allergen method and the petrolatum reference allergen method, calculated using Cohen's kappa and positive and negative percent agreement.[1][1] The study tests a panel of metal allergens including nickel sulfate, copper sulfate, tin, manganese, ammonium titanium oxide oxalate, zinc, gold sodium thiosulfate, sodium tetrachloropalladate, cobalt chloride, vanadium oxide sulfate, and potassium dichromate.[1][1]
Patch testing can cause local skin reactions at the application site, such as redness, itching, or irritation. The trial records do not provide a detailed side effect profile for stannous chloride dihydrate.[1][1] The diagnostic kit containing stannous fluoride carries no specific side effect information in the provided source.[2]
Each condition opens its own overview and trial list
Recruiting trials first
Tell us about your condition – we search every trial in Europe and connect you with the right site.