NCT02869867

Brief Summary

Nursing study, prospective, randomized, two-center open-label. Patients will be randomized into two groups during their first laying Qutenza®:

  • Patients receiving the laying of Qutenza® without refrigerated cushion
  • Patients receiving the laying of Qutenza® associated with a refrigerated cushion The objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (Qutenza®) in patients localized neuropathic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

August 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

March 2, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2020

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

August 15, 2024

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

3.8 years

First QC Date

August 12, 2016

Results QC Date

June 15, 2023

Last Update Submit

November 27, 2025

Conditions

Localized Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Pain Scale (Burning Pain)

    Burning pain will be estimated by the patient using a non-graduated 10 cm line, presented horizontally to the patient with the extreme position of the vertical border on the left (0mm) representing the absence of perceived pain and the extreme position on the right (10 cm), the perception of the maximum pain that the patient can imagine. The information obtained is measured and translated into a score between 0 and 10. The patient will be asked: "How would you rate the intensity of pain caused by Qutenza patch application?

    after 1 hour of installation of Qutenza patch

Study Arms (2)

Qutenza® without refrigerated cushion

NO INTERVENTION

Qutenza® without refrigerated cushion

Qutenza® with refrigerated cushion

EXPERIMENTAL

Qutenza® with refrigerated cushion

Other: refrigerated cushion

Interventions

refrigerated cushionOTHER

refrigerated cushion

Qutenza® with refrigerated cushion

Eligibility Criteria

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

You may qualify if:

  • Major
  • Do not opposing the participation in the study
  • Monitoring in the case of localized neuropathic pain
  • Diagnostic with neuropathic pain score ≥ 4
  • Neuropathic pain conventional treatment failure of first-line
  • Front advantage of laying a first patch Qutenza®
  • With ability to understand the proposed study

You may not qualify if:

  • Patch Installation on the feet, face, mucous membranes
  • Eutectic mixture of local anesthetics (EMLA) Pose premedication
  • Having Already received prior to the installation of a patch of Qutenza®
  • Allergy to components Qutenza®
  • Known and poorly stabilized hypertension
  • Known cryoglobulinaemia
  • Pregnant or lactating women
  • Patient enjoying a measure of legal protection (guardianship, guardianship ...)
  • Private Patient freedom
  • No affiliation to a social security scheme.
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHLVO de Challans

Challans, 85300, France

Location

CHD Vendée de la Roche sur Yon

La Roche-sur-Yon, 85925, France

Location

Clinique Brétéché

Nantes, 44000, France

Location

Related Publications (1)

  • Tailliez N, Planche L, Dorion A, Kacki N, Dimet J, Pluchon YM. Effect of Cooling Capsaicin Application Site on Reducing Burning Sensation in Neuropathic Pain Patients: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Apr;26(2):e159-e164. doi: 10.1016/j.pmn.2024.09.001. Epub 2024 Nov 12.

    PMID: 39532578RESULT

Results Point of Contact

Title
Dr Yves-Marie PLUCHON
Organization
Centre Hospitalier Départemental Vendée
yves-marie.pluchon@chd-vendee.fr
251446248

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 17, 2016

Study Start

March 2, 2017

Primary Completion

December 4, 2020

Study Completion

December 4, 2020

Last Updated

December 3, 2025

Results First Posted

August 15, 2024

Record last verified: 2025-11

Locations

FR(3)