Transdermal Iontophoresis of Vitamin B12 Under Three Different Skin Preparations
Public ClinicalTrials.gov record NCT04027959. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04027959
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 10 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 4, 2017
- Primary completion
- Oct 3, 2018
- Completion
- Oct 31, 2018
- Last update posted
- Dec 13, 2020
2017 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| James J Peters VA Medical Center | The Bronx | New York | 10468 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04027959, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 13, 2020 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04027959 live on ClinicalTrials.gov.