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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03081403
Other study ID # SENSISKIN 29CRB16.0100
Secondary ID
Status Completed
Phase N/A
First received March 10, 2017
Last updated October 18, 2017
Start date April 14, 2017
Est. completion date October 17, 2017

Study information

Verified date October 2017
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date October 17, 2017
Est. primary completion date September 22, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cutaneous perception threshold The cutaneous perception threshold of pain to heat. 6 months
Secondary The cutaneous perception threshold of vibration The cutaneous perception threshold of pain to harm. 6 months
Secondary The cutaneous perception threshold of cold The cutaneous perception threshold of cold 6 months
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