NCT03081403

Brief Summary

Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have sensitive skin. The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients stimuli of different modalities to measure a subjective somatosensory response. This allows to characterize sensory dysfunction by assessing the participation of small and large nerve fibers. The aim of this project is to characterize the presence or absence of a neurological disorder in patients with sensitive skin. This discovery would be a decisive argument to reinforce the suspicion that sensitive skins is linked to a small fiber neuropathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

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

March 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

April 14, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2017

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

March 10, 2017

Last Update Submit

February 3, 2025

Conditions

Sensitive Skin

Keywords

Sensitive skinQuantitative Sensory Testing

Outcome Measures

Primary Outcomes (1)

  • Cutaneous perception threshold

    The cutaneous perception threshold of pain to heat.

    6 months

Secondary Outcomes (2)

  • The cutaneous perception threshold of vibration

    6 months

  • The cutaneous perception threshold of cold

    6 months

Study Arms (2)

Subjects with sensitive skin

OTHER

Subjects with a score greater than 50 on the sensitive scale

Device: Quantitative Sensory Testing

Subjects without sensitive skin

OTHER

Subjects with result lower than 20 on the sensitive scale

Device: Quantitative Sensory Testing

Interventions

Quantitative Sensory TestingDEVICE

Study of detection thresholds of vibration, cold and pain related to the heat in the dominant hand of the subjects through the QST.

Subjects with sensitive skinSubjects without sensitive skin

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: between 20 and 60 years
  • Cooperating patient
  • Informed and written consent of the subject
  • Affiliated to the social security
  • For subjects with sensitive skin:
  • subjects with a score greater than 50 on the scale sensitive scale
  • \- To control subjects: subjects with result of less than 20 sensitive to the scale scale

You may not qualify if:

  • Adults subject with legal protection
  • Subject in a social institution.
  • Subject with major cognitive or psychiatric disorders
  • Subject with pathological use of alcohol or consumption of another drug.
  • Subject with skin involvement of the back of the dominant hand or malformation.
  • Known sensitive neuropathy
  • Pregnant woman
  • Subject receiving medical treatment which may interfere with the results.
  • Subject with treatment in the back of the dominant hand.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29200, France

Location

Study Design

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

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 16, 2017

Study Start

April 14, 2017

Primary Completion

September 22, 2017

Study Completion

October 27, 2017

Last Updated

February 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)