Effect of Vitamin D After Application With Valchlor

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical Application With Valchlor

Conditions
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Skin Irritation

Intervention / Treatment
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* Dietary Supplement: 4 placebo
* Dietary Supplement: 4 Vitamin D
* Drug: Valchlor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1: 4 placebo - 0 Vitamin D with Valchlor<br>Participants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor. | Dietary Supplement: 4 placebo<br>* subjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills<br>* Other names: placebo;Drug: Valchlor<br>* 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<br>* Other names: Mechlorethamine;|
| Experimental: Group 2: 0 placebo - 4 Vitamin D with mechloroethamine<br>Participants will be given 0 placebo capsules and 4 cholecalciferol capsules to total 200,000 IU of cholecalciferol (Vitamin D) after being treated with Valchlor. | Dietary Supplement: 4 Vitamin D<br>* subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)<br>* Other names: cholecalciferol;Drug: Valchlor<br>* 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<br>* Other names: Mechlorethamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 1 week after mechloroethamine exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | Up to 120 hours after mechloroethamine exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valchlor, Vitamin D, Healthy Volunteer