The purpose of this research study is to evaluate the effects of an oral Vitamin D on the body's immune system. An interest has been growing because studies have shown that Vitamin D may reduce inflammation and harmful effects in the body, however, the best dose for Vitamin D is still unknown. Inflammation is the body's physical response to infection, injury, or long term disease. Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the body. This study will look at product use, testing skin irritation in healthy volunteers and seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could one day help doctors prescribe Vitamin D to patients with long term disease to relieve their symptoms.
Primary Endpoint To determine the effect of a topical application of Valchlor on human subjects at the clinically approved dose. Secondary Endpoint To establish the efficacy of cholecalciferol (vitamin D3) in reducing skin irritation 48 hours after topical application of Valchlor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
33
subjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills
subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)
Twice during the study, subjects will be given 0.016% Valchlor at 3 locations (for a total of 6 locations) in the inner arm using Finn ChambersTM
University Hospitals
Cleveland, Ohio, United States
Change in skin erythema
Skin erythema (redness) will be quantified using a CR300 chromameter. The difference in erythema between exposed and non-exposed skin will be calculated after valchlor exposure
Time frame: Up to 1 week after mechloroethamine exposure
Change in skin thickness
Skin thickness, an acute measure of edema, was quantified using a Mitutoyo 9mm dial caliper. Thickness measurements will be repeated in triplicate and the mean was used for all calculations. The difference in thickness between exposed and non-exposed skin will be calculated after valchlor exposure.
Time frame: Up to 1 week after mechloroethamine exposure
Change in TNF-alpha expression
A 6 mm punch biopsy specimen will be obtained from the valchlor exposure site 48hr after exposure. RNA will be extracted from fresh frozen punch biopsies using the RNeasy Lipid Mini Kit, and tissue mRNA expression of TNF-α will be quantified
Time frame: Up to 120 hours after mechloroethamine exposure
Change in iNOS expression
A 6 mm punch biopsy specimen will be obtained from the valchlor exposure site 48hr after exposure. RNA will be extracted from fresh frozen punch biopsies using the RNeasy Lipid Mini Kit, and tissue mRNA expression of iNOS will be quantified
Time frame: Up to 120 hours after mechloroethamine exposure
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