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

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.

Study Overview

• Status: Completed
• Conditions: Sensitive Skin
• Intervention / Treatment: Device: Quantitative Sensory Testing

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subjects with sensitive skin; Subjects with a score greater than 50 on the sensitive scale	Device: Quantitative Sensory Testing; Study of detection thresholds of vibration, cold and pain related to the heat in the dominant hand of the subjects through the QST.
Other: Subjects without sensitive skin; Subjects with result lower than 20 on the sensitive scale	Device: Quantitative Sensory Testing; Study of detection thresholds of vibration, cold and pain related to the heat in the dominant hand of the subjects through the QST.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cutaneous perception threshold	The cutaneous perception threshold of pain to heat.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cutaneous perception threshold of vibration	The cutaneous perception threshold of pain to harm.	6 months
The cutaneous perception threshold of cold	The cutaneous perception threshold of cold	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2017
• Primary Completion (Actual): September 22, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Quantitative Sensory Testing; Sensitive skin
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: SENSISKIN 29CRB16.0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No