Sensitive SkinSENSISKINNCT03081403
Quantitative Sensory Testing in Subjects With Sensitive Skin or Not
A study testing Quantitative Sensory Testing in people with Sensitive Skin, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitive Skin
- What is being tested?
- Quantitative Sensory Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2017to 27 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Pregnant woman
- Subject receiving medical treatment which may interfere with the results.
- Subject with treatment in the back of the dominant hand.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sensitive Skin
- Being tested
- Quantitative Sensory Testing
- Keywords
- Sensitive skin, Quantitative Sensory Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with sensitive skin | Other | Subjects with a score greater than 50 on the sensitive scale Receives: Device: Quantitative Sensory Testing |
| Subjects without sensitive skin | Other | Subjects with result lower than 20 on the sensitive scale Receives: Device: Quantitative Sensory Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous perception threshold
The cutaneous perception threshold of pain to heat.
Measured: 6 months
Secondary outcomes (2)
The cutaneous perception threshold of vibration
The cutaneous perception threshold of pain to harm.
Measured: 6 months
The cutaneous perception threshold of cold
The cutaneous perception threshold of cold
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start14 Apr 2017
- Primary completion22 Sep 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitive SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081403
- Sponsor's protocol ID
- SENSISKIN 29CRB16.0100
- Acronym
- SENSISKIN
- Status last verified
- Feb 2025
- First submitted
- 10 Mar 2017
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Sensory Testing in Subjects With Sensitive Skin or Not
- ClinicalTrials.gov ID
- NCT03081403
- Acronym / sponsor ID
- SENSISKIN / SENSISKIN 29CRB16.0100
- Conditions
- Sensitive Skin
- Keywords
- Sensitive skin, Quantitative Sensory Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 22 Sep 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with sensitive skin | Other | Device: Quantitative Sensory TestingSubjects with a score greater than 50 on the sensitive scale |
| Subjects without sensitive skin | Other | Device: Quantitative Sensory TestingSubjects with result lower than 20 on the sensitive scale |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Sensory TestingStudy of detection thresholds of vibration, cold and pain related to the heat in the dominant hand of the subjects through the QST. | Device | Subjects with sensitive skin, Subjects without sensitive skin |
Primary outcome
Cutaneous perception threshold
Time frame: 6 months
The cutaneous perception threshold of pain to heat.
2 secondary outcomes
The cutaneous perception threshold of vibration
Time frame: 6 months
The cutaneous perception threshold of cold
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative Sensory Testing in people with Sensitive Skin, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous perception threshold (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.