Safety and Tolerability of the Derma Vax(Trademark) Clinical Intradermal Electroporation System in Healthy Subjects
Public ClinicalTrials.gov record NCT01324843. 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
Safety and Tolerability of the Derma Vax Clinical Intradermal Electroporation System in Healthy Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 will also be asked their opinions on whether (based on pain levels) a series of Derma Vax(Trademark) treatments would be acceptable for treatment of a serious illness. * The day after the injection, participants will return for an additional skin assessment of the treated areas.
Study identification
- NCT ID
- NCT01324843
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Interventions
- EMLA Cream Drug
- Aveeno Daily Moist Drug
- Derma Vax Device
- Intradermal Electroporation Procedure
- Visual Analogue Scale Procedure
- Present Pain Intensity Procedure
- McGill Pain Questionnaire Procedure
- Skin Assessment Procedure
Drug · Device · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 55 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
- Jun 24, 2009
- Primary completion
- May 26, 2010
- Completion
- May 26, 2010
- Last update posted
- Jul 1, 2017
2009 – 2010
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institute of Aging, Harbor Hospital | Baltimore | Maryland | 21224 | — |
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 NCT01324843, 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 Jul 1, 2017 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01324843 live on ClinicalTrials.gov.