Ultra Violet B Radiation (UVR) Study of Strontium Chloride Hexahydrate Hydrocortisone (NCT01301677) | Clinical Trial Compass
CompletedPhase 1
Ultra Violet B Radiation (UVR) Study of Strontium Chloride Hexahydrate Hydrocortisone
Germany47 participantsStarted 2011-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 ā„ 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 clā¦
What they're measuring
1
Degree of erythema
Timeframe: at 6 h, 12 h, 24 h, 36 h, 48 h post UVR