NCT01523951

Brief Summary

Aim of the study is to demonstrate superiority of a continuous cooling of the skin over topical EMLA or placebo in reducing the burning pain during the application of capsaicin 8% patch ("Qutenza"). Secondary it will be tested, if the 2 different pre-treatments have an effect on the application pain within the first 24 hours, and if different pre-treatments have an effect on the reduction of the epidermal nerve fiber density (ENFD) 1 week after Qutenza application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

2 months

First QC Date

January 29, 2012

Last Update Submit

March 19, 2012

Conditions

Pain

Keywords

topical local anaesthesiacoolingcapsaicin 8%epidermal nerve fiber densitytreatment pain

Outcome Measures

Primary Outcomes (1)

  • burning pain during the application of capsaicin 8% patch

    60 minutes

Secondary Outcomes (2)

  • application pain within the first 24 hours after application of capsaicin 8% patch

    24 hours

  • epidermal nerve fiber density(ENFD)

    1 week

Study Arms (1)

Healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy volunteers

You may qualify if:

  • healthy volunteers 18 ore more years old

You may not qualify if:

  • dermatologic or neurologic injuries on both thighs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Spec. Anesthesia and Pain Therapy

Vienna, Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin biopsy

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ao.Univ.-Prof. Dr. Erich Knolle

Study Record Dates

First Submitted

January 29, 2012

First Posted

February 1, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

AU(1)