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NCT01324843 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of the Derma Vax(Trademark) Clinical Intradermal Electroporation System in Healthy Subjects
A Phase 1 study, sponsored by National Institute on Aging (NIA).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01324843 is a Phase 1 study that has completed, run by National Institute on Aging (NIA). The registered enrollment target is 24 participants.
The verdict
NCT01324843, a Phase 1 study, has completed, sponsored by National Institute on Aging (NIA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Background: \- Researchers are investigating the use of DNA vaccines to treat various types of cancer by provoking an immune system response to tumor cells. DNA vaccines mimic the effect of normal vaccines given to prevent infectious diseases, but they have been less effective than anticipated in humans. To improve the effectiveness of DNA vaccines, researchers are studying alternate delivery methods, such as the investigational Derma Vax(Trademark) injection system that delivers the vaccine into the skin. However, because the Derma Vax(Trademark) system has not been studied in humans, more research is needed to determine whether this new vaccine delivery method is safe and tolerable, particularly in terms of pain levels and skin reactions. Objectives: \- To evaluate the safety, effectiveness, and relative pain levels of intradermal electroporation using Derma Vax(Trademark) administered after pretreatment with either a topical cream anesthetic or placebo cream. Eligibility: \- Healthy individuals between 18 and 55 years of age. Design: * Participants will be screened with a medical history, physical examination, blood and urine tests, and an electrocardiogram. * Participants will have two different creams applied to their upper arms: one cream will be an anesthetic (lidocaine and prilocaine) and the other will be a placebo lotion. Each arm will receive a different cream. * Once the cream has taken effect, participants will receive Derma Vax(Trademark) treatment. No actual medication will be given during the injection; participants will evaluate their reaction based on the pressure and needle stick alone. * Immediately after the treatment, participants will use the Visual Analogue Scale of pain intensity to provide a description of the level of pain experienced during the injection. * Participants will complete additional questionnaires about pain intensity and will have the injected skin site inspected to determine possible reactions to the injection. They w
Interventions
- DRUG EMLA Cream
- DRUG Aveeno Daily Moist
- DEVICE Derma Vax
- PROCEDURE Intradermal Electroporation
- PROCEDURE Visual Analogue Scale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-06-25 |
| Est. Completion | 2010-05-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01324843
The ClinicalTrials.gov registry entry for NCT01324843 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Aging (NIA), which has 131 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which EMLA Cream is the first listed.
NCT01324843 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01324843 about?
NCT01324843 is a clinical study titled "Safety and Tolerability of the Derma Vax(Trademark) Clinical Intradermal Electroporation System in Healthy Subjects". Background: \- Researchers are investigating the use of DNA vaccines to treat various types of cancer by provoking an immune system response to tumor cells. DNA vaccines mimic the effect of normal vaccines given to prevent infectious diseases, but they have been less effective than anticipated in h...
What is the current status of trial NCT01324843?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-06-25. Estimated completion is 2010-05-27.
What interventions are being tested in trial NCT01324843?
The interventions under investigation include: EMLA Cream (DRUG), Aveeno Daily Moist (DRUG), Derma Vax (DEVICE), Intradermal Electroporation (PROCEDURE), Visual Analogue Scale (PROCEDURE).
Who is sponsoring clinical trial NCT01324843?
This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.
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