Effect of Vitamin D After Application With Valchlor

Skin Irritation Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Skin Irritation

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