Sensitive ScalpSENSISCALPNCT07156422
Pathophysiological Study of the Sensitive Scalp
A study testing A scalp biopsy using a 4 mm punch in the retroauricular hair zone, a general health questionnaire and Questionnaires concerning their sensitive scalp in people with Sensitive Scalp, run by University Hospital, Brest at 1 site in France.
Trial summary
Sensitive skin is defined as a syndrome manifested by the occurrence of unpleasant sensations (tingling, burning, pain, pins and needles) in response to stimuli that should not normally cause them. These unpleasant sensations cannot be explained by lesions attributable to a specific skin disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sensitive Scalp
- What is being tested?
- A scalp biopsy using a 4 mm punch in the retroauricular hair zone, a general health questionnaire and Questionnaires concerning their sensitive scalp
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult women without dermatosis
- Collection of free and informed consent
- patient affiliated to a social security scheme
- For the control group: Sensiscalp score = 0/20 Sensitive scalp group: Sensiscalp score ≥ 3/20 with pruritus sensation ≥ 2/20
Who cannot join
- Refusal to take part in the study
- Dermatosis of the scalp (psoriasis, seborrhoeic dermatitis, etc.)
- Pregnant and breast-feeding women
- Women under legal protection (guardianship, curatorship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Brest
Brest, 29200
Emilie BRENAUT, PhD, 2 98 22 35 90 ext. +33, emilie.brenaut@univ-brest.fr ; emilie.brenaut@chu-brest.fr
emilie BRENAUT, PhD
About this study
Sensitive skin is defined as a syndrome manifested by the occurrence of unpleasant sensations (tingling, burning, pain, pins and needles) in response to stimuli that should not normally cause them. These unpleasant sensations cannot be explained by lesions attributable to a specific skin disease. Sensitive skin can affect different parts of the body. The scalp is a site that is often affected, with specificity linked in particular to the presence of hair and different triggering factors (styling habits, wearing of head coverings, application of cosmetics to the scalp, etc.). Sensitive scalp affects around half the population, and can have an impact on the quality of life of sufferers, particularly those whose symptoms are very intense. Women are more likely than men to have a sensitive scalp, so in order to have a more homogenous study population, we chose to include 40 women. The pathophysiology of sensitive skin is imperfectly understood, and studies specific to the sensitive scalp are very rare. However, the pathophysiology of the sensitive scalp could be different because it is a hairy area, more innervated, and less exposed to environmental factors.
Read the detailed description
Each patiente will have a sample taken in the dermatology department:
- 1 skin biopsy of the scalp (non-routine medical procedure)
- Completion of questionnaires
- Collection of skin microbiota (optional) 40 adult women
- 20 women with a sensitive scalp (cases)
- 20 women without a sensitive scalp (controls)
Patientes with the sensitive scalp will be recruited from the dermatology department. There will be no further visits, so the duration of the study is 1 day.
- Conditions
- Sensitive Scalp
- Being tested
- A scalp biopsy using a 4 mm punch in the retroauricular hair zone, a general health questionnaire, Questionnaires concerning their sensitive scalp, Collection of skin microbiota
- Keywords
- sensitive scalp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A scalp biopsy using a 4 mm punch in the retroauricular hair zoneProcedure or surgery
a scalp biopsy using a 4 mm punch in the retroauricular hair zone under local anesthesia
a general health questionnaireOther
a general health questionnaire : demographics, history, treatment, smoking, alcohol consumption, phototype.
Questionnaires concerning their sensitive scalpOther
- The characteristics of a sensitive scalp (location, chronicity, triggering and soothing factors, use of cosmetics, etc.)
- Sensitive Scalp Score (3S)
- Impact on quality of life: BoSS questionnaire
- Impact of pruritus on quality of life (ItchyQol)
Collection of skin microbiotaProcedure or surgery
The skin microbiome is collected using a sterile swab rubbed against the scalp for 60 seconds
| Study group | Role | What they receive |
|---|---|---|
| Case group (patient with sensitive scalp) | Other | A 'sensitive scalp' group, with an overall 3S score ≥3 and a pruritus sub-score ≥2. As pruritus is widely described as the main symptom of sensitive scalp, recruitment will be based on the presence of pruritus. Receives: Procedure: A scalp biopsy using a 4 mm punch in the retroauricular hair zone; Other: a general health questionnaire; Other: Questionnaires concerning their sensitive scalp; Procedure: Collection of skin microbiota |
| Control group (patient with "normal" scalp) | Other | - A 'non-sensitive scalp' group, with a 3S score of 0. Receives: Procedure: A scalp biopsy using a 4 mm punch in the retroauricular hair zone; Other: a general health questionnaire; Procedure: Collection of skin microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the pathophysiology of the sensitive scalp based on a study of the genes expressed in the cutaneous tissue
- mRNA in biopsy by bulk transcriptomic -> Identify differentially expressed genes between the two groups (sensitive scalp and non-sensitive scalp)
- mRNA in biopsy by RNAscope -> Quantify and localized expression of interest's genes
Measured: 1 day
Secondary outcomes (3)
Histological study of skin tissue
- Histological features in biopsies - Routine staining -> Visualize/Compare skin architecture between the 2 groups (sensitive scalp and non-sensitive scalp),
- Protein expression in biopsies - immunofluorescent staining -> Compare the status of keratinocytes between the two groups (sensitive scalp and non-sensitive scalp)
- Protein expression in biopsies - immunofluorescent staining -> Compare the Receptors and ion channels expression known to be involved in pruritus between the 2 groups (sensitive scalp and non-sensitive scalp)
Measured: 1 day
Study of innervation
- Protein expression in biopsies - immunofluorescent staining -> Quantify free nerve endings in the epidermis and the dermis and compare between the 2 groups (sensitive scalp and non-sensitive scalp)
Measured: 1 day
Study of the skin microbiome
Quantification and characterization of microorganisms
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start28 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitive ScalpStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- case-control study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156422
- Sponsor's protocol ID
- 29BRC24.0318 - SENSISCALP
- Acronym
- SENSISCALP
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Study of the Sensitive Scalp
- ClinicalTrials.gov ID
- NCT07156422
- Acronym / sponsor ID
- SENSISCALP / 29BRC24.0318 - SENSISCALP
- Conditions
- Sensitive Scalp
- Keywords
- sensitive scalp
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Sep 2025 (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 defined as a syndrome manifested by the occurrence of unpleasant sensations (tingling, burning, pain, pins and needles) in response to stimuli that should not normally cause them. These unpleasant sensations cannot be explained by lesions attributable to a specific skin disease. Sensitive skin can affect different parts of the body. The scalp is a site that is often affected, with specificity linked in particular to the presence of hair and different triggering factors (styling habits, wearing of head coverings, application of cosmetics to the scalp, etc.). Sensitive scalp affects around half the population, and can have an impact on the quality of life of sufferers, particularly those whose symptoms are very intense. Women are more likely than men to have a sensitive scalp, so in order to have a more homogenous study population, we chose to include 40 women. The pathophysiology of sensitive skin is imperfectly understood, and studies specific to the sensitive scalp are very rare. However, the pathophysiology of the sensitive scalp could be different because it is a hairy area, more innervated, and less exposed to environmental factors.
Detailed description
Each patiente will have a sample taken in the dermatology department:
- 1 skin biopsy of the scalp (non-routine medical procedure)
- Completion of questionnaires
- Collection of skin microbiota (optional) 40 adult women
- 20 women with a sensitive scalp (cases)
- 20 women without a sensitive scalp (controls)
Patientes with the sensitive scalp will be recruited from the dermatology department. There will be no further visits, so the duration of the study is 1 day.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- case-control study
| Arm | Type | Receives |
|---|---|---|
| Case group (patient with sensitive scalp) | Other | Procedure: A scalp biopsy using a 4 mm punch in the retroauricular hair zone, Other: a general health questionnaire, Other: Questionnaires concerning their sensitive scalp, Procedure: Collection of skin microbiotaA 'sensitive scalp' group, with an overall 3S score ≥3 and a pruritus sub-score ≥2. As pruritus is widely described as the main symptom of sensitive scalp, recruitment will be based on the presence of pruritus. |
| Control group (patient with "normal" scalp) | Other | Procedure: A scalp biopsy using a 4 mm punch in the retroauricular hair zone, Other: a general health questionnaire, Procedure: Collection of skin microbiota- A 'non-sensitive scalp' group, with a 3S score of 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult women without dermatosis
- Collection of free and informed consent
- patient affiliated to a social security scheme
- For the control group: Sensiscalp score = 0/20 Sensitive scalp group: Sensiscalp score ≥ 3/20 with pruritus sensation ≥ 2/20
Key exclusion criteria (4 listed)
- Refusal to take part in the study
- Dermatosis of the scalp (psoriasis, seborrhoeic dermatitis, etc.)
- Pregnant and breast-feeding women
- Women under legal protection (guardianship, curatorship)
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 |
|---|---|---|
| A scalp biopsy using a 4 mm punch in the retroauricular hair zonea scalp biopsy using a 4 mm punch in the retroauricular hair zone under local anesthesia | Procedure or surgery | Case group (patient with sensitive scalp), Control group (patient with "normal" scalp) |
| a general health questionnairea general health questionnaire : demographics, history, treatment, smoking, alcohol consumption, phototype. | Other | Case group (patient with sensitive scalp), Control group (patient with "normal" scalp) |
| Questionnaires concerning their sensitive scalp* The characteristics of a sensitive scalp (location, chronicity, triggering and soothing factors, use of cosmetics, etc.) * Sensitive Scalp Score (3S) * Impact on quality of life: BoSS questionnaire * Impact of pruritus on quality of life (ItchyQol) | Other | Case group (patient with sensitive scalp) |
| Collection of skin microbiotaThe skin microbiome is collected using a sterile swab rubbed against the scalp for 60 seconds | Procedure or surgery | Case group (patient with sensitive scalp), Control group (patient with "normal" scalp) |
Primary outcome
Study the pathophysiology of the sensitive scalp based on a study of the genes expressed in the cutaneous tissue
Time frame: 1 day
1. mRNA in biopsy by bulk transcriptomic -> Identify differentially expressed genes between the two groups (sensitive scalp and non-sensitive scalp) 2. mRNA in biopsy by RNAscope -> Quantify and localized expression of interest's genes
3 secondary outcomes
Histological study of skin tissue
Time frame: 1 day
Study of innervation
Time frame: 1 day
Study of the skin microbiome
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Sensitive Scalp
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Atopic Dermatitis, Alopecia Areata
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A scalp biopsy using a 4 mm punch in the retroauricular hair zone, a general health questionnaire and Questionnaires concerning their sensitive scalp in people with Sensitive Scalp, 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie BRENAUT, Dr (2 98 22 35 90 ext. +33, emilie.brenaut@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the pathophysiology of the sensitive scalp based on a study of the genes expressed in the cutaneous tissue (time frame: 1 day). 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 24 Jun 2026.