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Trial record 24 of 580 for:    applied AND irritation

Effect of Vitamin D After Application With Valchlor

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ClinicalTrials.gov Identifier: NCT02968446
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : November 20, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Kurt Lu, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE November 16, 2016
First Posted Date  ICMJE November 18, 2016
Last Update Posted Date November 20, 2017
Actual Study Start Date  ICMJE November 17, 2016
Estimated Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
Change in skin erythema [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02968446 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • Change in skin thickness [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
  • Change in skin thickness [ Time Frame: 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 [ Time Frame: Up to 48 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 [ Time Frame: Up to 48 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Vitamin D After Application With Valchlor
Official Title  ICMJE The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical Application With Valchlor
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Skin Irritation
Intervention  ICMJE
  • 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
    Other Name: placebo
  • Dietary Supplement: 4 Vitamin D
    subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)
    Other Name: 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
    Other Name: Mechlorethamine
Study Arms  ICMJE
  • Placebo Comparator: Group 1: 4 placebo - 0 Vitamin D with Valchlor
    Participants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor.
    Interventions:
    • Dietary Supplement: 4 placebo
    • Drug: Valchlor
  • Experimental: Group 2: 0 placebo - 4 Vitamin D with mechloroethamine
    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.
    Interventions:
    • Dietary Supplement: 4 Vitamin D
    • Drug: Valchlor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 16, 2016)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2018
Estimated Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kurt Lu, MD 216-368-2333 kurt.lu@uhhospitals.org
Contact: Mary Consolo 216-844-7834 mary.consolo@case.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02968446
Other Study ID Numbers  ICMJE 09-16-36C
U01AR064144-01 ( U.S. NIH Grant/Contract )
CASE3416 ( Other Identifier: Case Comprehensive Cancer Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kurt Lu, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Kurt Lu, MD University Hospitals, Case Comprehensive Cancer Center
PRS Account University Hospitals Cleveland Medical Center
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP