Skin Irritation
Conditions
Keywords
Valchlor, Vitamin D, Healthy Volunteer
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENT4 placebo
subjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills
DIETARY_SUPPLEMENT4 Vitamin D
subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)
DRUGValchlor
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
Sponsors
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be in general good health * Fitzpatrick Skin Type I-VI * Able to list all current medications and medical conditions * Capable of giving informed consent
Exclusion criteria
* Women who are pregnant, nursing, or who may become pregnant in the next 3 months * Participants taking illegal drugs * Currently taking ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin, or mineral oil * Currently consuming 800IU or more of vitamin D a day * Subjects whose BMI are \> 40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin erythema | Up to 1 week after mechloroethamine exposure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin thickness | Up to 1 week after mechloroethamine exposure | 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. |
| Change in TNF-alpha expression | Up to 120 hours after mechloroethamine exposure | 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 |
| Change in iNOS expression | Up to 120 hours after mechloroethamine exposure | 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 |
Countries
United States
Outcome results
None listed