Ultra Violet B Radiation (UVR) Study of Strontium Chloride Hexahydrate Hydrocortisone

This is an interventional treatment trial for Erythema Read More

Inclusion Criteria:

• Signed and dated informed consent prior to any study-mandated procedure
• Subjects in good health as determined by the Investigator
• Willing and able to comply with study requirements
• Age ≥ 18
• Fitzpatrick skin types I, II, or III
• Willing to avoid sun exposure, tanning lamps and use of any topical products on the test areas during the study
• Willing not to wash test areas during treatment period
• Willing to abstain from sauna, exposure to extreme cold or major physical activities during the treatment period of the study
• For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation

Exclusion Criteria:

General

• Planned treatment or treatment with another investigational drug within 30 days prior to randomization.
• Subjects who are inmates of psychiatric wards, prisons, or other state institutions
• Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
• Pregnancy or lactation
• Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.

Medical History

• Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma
• Known hypersensitivity or allergy (including photoallergy) to hydrocortisone, strontium chloride hexahydrate, glycofurol, dimethylsulphoxide (DMSO), ethanol, propylene glycol, glycerol, hypomellose, sodium edentate, sodium hydroxide, citric acid monohydrate and metagin
• History of photosensitivity disease
• Sunburn, excessive tan, uneven skin tones or blemishes of the test areas
• Pain conditions which might interfere with pain rating during the study, e.g. neuropathic pain
• Open wounds, infection, inflammation or other dermal diseases of the intended application areas
• ALT or AST ≥ 5 times the ULN
• Glomerulary filtration rate < 30 ml/min

Medication History

• Systemic or topical drugs that might affect responses to UVR or interfere with responses to IMP including corticosteroids, thiazides, tetracyclines and NSAIDs must be washed out with 5 times half-life time prior to randomization to treatment
• Drugs with potential dermatologic adverse events defined by the respective summary of product characteristics (e.g. tetracyclines, gyrase inhibitors) must be washed out with 5 times half-life time prior to randomization to treatment