Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 5 of 1601 for:    veterans affairs medical center

Vitamin B12 Three Skin Preps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04027959
Recruitment Status : Completed
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Mark Korsten, James J. Peters Veterans Affairs Medical Center

Brief Summary:

STUDY DESIGN: Phase I Clinical Trial The researchers set out to assess the effectiveness of transdermal iontophoretic administration of Vitamin B12 (V.B12) under three different skin preparatory conditions.

SETTING: James J. Peters Veterans Affairs Medical Center (Bronx, NY) BACKGROUND: Poor skin permeability precludes the use of transdermal route from being used in common clinical practice for rapid and precise administration of medications through intact skin that are expected to have a systemic effect. The researchers determined the relative effectiveness of an unconventional transdermal iontophoresis technique for the administration of Vitamin B12 (V.B12) under three different skin preparatory conditions.

METHODS: During this study, Vitamin B12 (V.B12) was administered through the skin of volunteer human research subjects. Iontophoresis was used as transdermal medication delivery modality after pre-treatment of the skin in 3 different ways. The sequence of skin preparations was arranged in a random order for each subject. Method 1 was called "No Prep", serving as the control approach; method 2 was called "Oleic Acid" application to the skin for 40 minutes; and method 3 was hair "Epilation" (e.g. hair removal by plucking). Fifteen milligrams of aqueous solution of V.B12 was administered through intact, previously unused skin of an anterior thigh during all 3 tests. Chemoluminescence, on an automated laboratory reader Advia Centaur-XP, was used to determine the serum concentration of V.B12 prior to and after transdermal iontophoretic delivery. All 3 experiments were performed on the same day within an hour of each other. The subject's blood was drawn prior and 10 minutes after the 20-minute long sessions of transdermal V.B12 iontophoresis. We were able to calculate the increase in serum V.B12 concentration and based on estimated blood volume, the total quantity and percent dose delivered systemically.


Condition or disease Intervention/treatment Phase
Delivering Vitamin B12 Through Intact Skin Without Disturbing the Integrity of the Skin Dietary Supplement: Vitamin B12 Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Novel Skin Preparation Approaches for Transdermal Delivery by Iontophoresis of a Low Molecular Weight, Positively Charged Compound (Vitamin B12) to the Systemic Circulation
Actual Study Start Date : October 5, 2017
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Arm Intervention/treatment
Experimental: Epilation
Hair epilated prior to application of Vitamin B12 solution to skin
Dietary Supplement: Vitamin B12
Diffusion of Vitamin B12 through the skin over 20 minutes under the effect of low amount of direct electric current
Other Name: Iontophoresis

Experimental: Oleic Acid
Oil is allowed to soak the skin prior to application of Vitamin B12 solution to skin
Dietary Supplement: Vitamin B12
Diffusion of Vitamin B12 through the skin over 20 minutes under the effect of low amount of direct electric current
Other Name: Iontophoresis

Experimental: No Prep
Skin is cleansed with an alcohol wipe prior to application of Vitamin B12 solution to skin
Dietary Supplement: Vitamin B12
Diffusion of Vitamin B12 through the skin over 20 minutes under the effect of low amount of direct electric current
Other Name: Iontophoresis




Primary Outcome Measures :
  1. Amount of Vitamin B12 delivered into the systemic circulation [ Time Frame: 20 minutes ]
    micrograms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able-bodied,
  • Male or female,
  • Between the ages of 18-80 years old.

Exclusion Criteria:

  • Previous adverse reaction or hypersensitivity to electrical stimulation,
  • Pregnancy (women who are sexually active and of childbearing potential must utilize a method of contraception and agree to maintain a contraceptive method until completion of the study),
  • Inability to provide informed consent,
  • History of ingrown hair folliculitis after shaving or epilation,
  • Allergy to Sodium Lauryl Sulfate, Oleic acid, Silver Chloride, Agarose Gel, Methylcobalamin, Citric Acid, Isopropyl alcohol, Benzocaine, Polyethylene film, Polyethylene Glycol solvent,
  • Concurrent illness with fever,
  • Concurrent participation in a research study,
  • VA employee.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027959


Locations
Layout table for location information
United States, New York
James J Peters VA Medical Center
Bronx, New York, United States, 10468
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Mark Korsten, MD Employee

Layout table for additonal information
Responsible Party: Dr. Mark Korsten, Doctor, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT04027959    
Other Study ID Numbers: KOR-17-34
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD information

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamins
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics