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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02968446
Other study ID # 09-16-36C
Secondary ID U01AR064144-01CA
Status Completed
Phase Early Phase 1
First received
Last updated
Start date November 17, 2016
Est. completion date October 1, 2018

Study information

Verified date December 2021
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date October 1, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
4 placebo
subjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills
4 Vitamin D
subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)
Drug:
Valchlor
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

Locations

Country Name City State
United States University Hospitals Cleveland Ohio

Sponsors (3)

Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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-a will be quantified Up to 120 hours after mechloroethamine exposure
Secondary 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
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