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Pathophysiological Study of the Sensitive Scalp

Pathophysiological Study of the Sensitive Scalp

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07156422
Acronym
SENSISCALP
Enrollment
40
Registered
2025-09-05
Start date
2026-01-28
Completion date
2027-01-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensitive Scalp

Keywords

sensitive scalp

Brief 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. 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.

Interventions

PROCEDUREA scalp biopsy using a 4 mm punch in the retroauricular hair zone

a scalp biopsy using a 4 mm punch in the retroauricular hair zone under local anesthesia

OTHERa general health questionnaire

a general health questionnaire : demographics, history, treatment, smoking, alcohol consumption, phototype.

OTHERQuestionnaires 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)

PROCEDURECollection of skin microbiota

The skin microbiome is collected using a sterile swab rubbed against the scalp for 60 seconds

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Histological and innervation analyses will be carried out in a blinded fashion.

Intervention model description

case-control study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Study the pathophysiology of the sensitive scalp based on a study of the genes expressed in the cutaneous tissue1 day1. 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

Secondary

MeasureTime frameDescription
Histological study of skin tissue1 day1. Histological features in biopsies - Routine staining -\> Visualize/Compare skin architecture between the 2 groups (sensitive scalp and non-sensitive scalp), 2. Protein expression in biopsies - immunofluorescent staining -\> Compare the status of keratinocytes between the two groups (sensitive scalp and non-sensitive scalp) 3. 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)
Study of innervation1 day1\) 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)
Study of the skin microbiome1 dayQuantification and characterization of microorganisms

Countries

France

Contacts

CONTACTEmilie BRENAUT, Dr
emilie.brenaut@chu-brest.fr2 98 22 35 90

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026