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.
Subjects that signed the informed consent and are eligible to the study will be irradiated on the back to evaluate their individual minimal erythema dose (MED). A training session (without study medication) will be performed in order to introduce subjects to the testing and rating procedures. Subjects will come in within 28 days of screening to start the treatment period of the study. For eligible subjects, three test areas oriented along the long axis of the back and different from the areas of MED determination will be defined for the evaluation of effects on pain and inflammation induced by UVR. The three areas will be irradiated with 2 MED. In addition, non-irradiated, not treated areas will serve as reference and training areas for the individual visits. Topical treatments will be randomly assigned to the three test areas.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
47
Hydrocortisone liquid formulation
strontium chloride hexahydrate in a penetration enhancing vehicle
strontium chloride hexahydrate without a penetration enhancing vehicle
X-pert Med GmbH
Gräfelfing, Bavaria, Germany
X-pert Med Gmbh
Jena, Thuringia, Germany
Degree of erythema
Time frame: at 6 h, 12 h, 24 h, 36 h, 48 h post UVR
Pain threshold (primary hyperalgesia to heat)
Time frame: Sum of assessments at 6 h, 12 h, 24 h, 36 h, 48 h post UVR
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