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Quantitative Sensory Testing in Subjects With Sensitive Skin or Not (SENSISKIN)

Primary Purpose

Sensitive Skin

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quantitative Sensory Testing
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sensitive Skin focused on measuring Sensitive skin, Quantitative Sensory Testing

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • CHRU de Brest

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Subjects with sensitive skin

Subjects without sensitive skin

Arm Description

Subjects with a score greater than 50 on the sensitive scale

Subjects with result lower than 20 on the sensitive scale

Outcomes

Primary Outcome Measures

Cutaneous perception threshold
The cutaneous perception threshold of pain to heat.

Secondary Outcome Measures

The cutaneous perception threshold of vibration
The cutaneous perception threshold of pain to harm.
The cutaneous perception threshold of cold
The cutaneous perception threshold of cold

Full Information

First Posted
March 10, 2017
Last Updated
October 18, 2017
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT03081403
Brief Title
Quantitative Sensory Testing in Subjects With Sensitive Skin or Not
Acronym
SENSISKIN
Official Title
Quantitative Sensory Testing in Subjects With Sensitive Skin or Not
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 14, 2017 (Actual)
Primary Completion Date
September 22, 2017 (Actual)
Study Completion Date
October 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have sensitive skin. A sensitive skin is characterized by the occurrence of tingling sensations, tightness, heat, burning, itching or pain triggered by non pathogenic factors such as wind, heat, cold, water , cosmetics, toiletries, stress... 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitive Skin
Keywords
Sensitive skin, Quantitative Sensory Testing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects with sensitive skin
Arm Type
Other
Arm Description
Subjects with a score greater than 50 on the sensitive scale
Arm Title
Subjects without sensitive skin
Arm Type
Other
Arm Description
Subjects with result lower than 20 on the sensitive scale
Intervention Type
Device
Intervention Name(s)
Quantitative Sensory Testing
Intervention Description
Study of detection thresholds of vibration, cold and pain related to the heat in the dominant hand of the subjects through the QST.
Primary Outcome Measure Information:
Title
Cutaneous perception threshold
Description
The cutaneous perception threshold of pain to heat.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The cutaneous perception threshold of vibration
Description
The cutaneous perception threshold of pain to harm.
Time Frame
6 months
Title
The cutaneous perception threshold of cold
Description
The cutaneous perception threshold of cold
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Quantitative Sensory Testing in Subjects With Sensitive Skin or Not

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