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.
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
