NCT03007264

Brief Summary

In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial effect will be investigated as well. The investigators expect this treatment to have a good antimicrobial effect with acceptable, transient skin sensations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2018

Completed
Last Updated

August 20, 2018

Status Verified

June 1, 2018

Enrollment Period

24 days

First QC Date

December 23, 2016

Last Update Submit

August 17, 2018

Conditions

Intact SkinContaminant Given to Patient

Keywords

cold atmospheric plasmapainbacteriaskin parameters

Outcome Measures

Primary Outcomes (1)

  • pain

    by using a visual analogue thermometer (VAT)

    before to 30 minutes after treatment

Secondary Outcomes (5)

  • local skin reaction

    directly to 30 minutes after treatment

  • local skin temperature

    before to 30 minutes after treatment

  • colour/pigmentation

    before to 30 minutes after treatment

  • trans epidermal water loss

    before to 30 minutes after treatment

  • reduction of the bacterial load

    directly to 5 minutes after treatment

Study Arms (3)

CAP treated

EXPERIMENTAL

volar arm will be treated with cold atmospheric plasma.

Device: Cold Atmospheric Plasma

CAP on bacteria

EXPERIMENTAL

volar arm with bacteria will be treated with cold atmospheric plasma.

Device: Cold Atmospheric Plasma

no CAP on bacteria

NO INTERVENTION

volar arm with bacteria will not be treated with cold atmospheric plasma. Sham comparator for measurements of skin parameters TEWL, temperature and bacterial load.

Interventions

Cold Atmospheric PlasmaDEVICE

CAP will be applied on one volar arm of volunteers for a total of 2 minutes.

CAP on bacteriaCAP treated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able and willing to comply with the research protocol
  • No language barrier

You may not qualify if:

  • Atopic dermatitis or other skin disease
  • Implanted electrical medical devices such cardiac pacemakers
  • Pregnant or lactating women
  • Patients with infected wounds.
  • Life-threatening cardiac conductivity abnormality
  • Active malignancy
  • Women of childbearing age not using contraceptive measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Association of Dutch Burn Centres

Beverwijk, North Holland, 1942 LE, Netherlands

Location

Related Publications (2)

  • Kisch T, Schleusser S, Helmke A, Mauss KL, Wenzel ET, Hasemann B, Mailaender P, Kraemer R. The repetitive use of non-thermal dielectric barrier discharge plasma boosts cutaneous microcirculatory effects. Microvasc Res. 2016 Jul;106:8-13. doi: 10.1016/j.mvr.2016.02.008. Epub 2016 Mar 2.

    PMID: 26944583RESULT

  • Brehmer F, Haenssle HA, Daeschlein G, Ahmed R, Pfeiffer S, Gorlitz A, Simon D, Schon MP, Wandke D, Emmert S. Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm((R)) VU-2010): results of a monocentric, two-armed, open, prospective, randomized and controlled trial (NCT01415622). J Eur Acad Dermatol Venereol. 2015 Jan;29(1):148-55. doi: 10.1111/jdv.12490. Epub 2014 Mar 25.

    PMID: 24666170RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Esther Middelkoop, PhD

    Red Cross Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2016

First Posted

January 2, 2017

Study Start

June 18, 2018

Primary Completion

July 12, 2018

Study Completion

July 26, 2018

Last Updated

August 20, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)