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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Double blinded (subject and observer), randomised, active (hydrocortisone (HC)) controlled study of the effect of strontium chloride hexahydrate on ultraviolet B radiation (UVR) induced signs of inflammation (erythema and pain) in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: X-pert Med GmbH
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

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