Pathophysiological Study of the Sensitive Scalp (SENSISCALP)

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.

Study Overview

• Status: Recruiting
• Conditions: Sensitive Scalp
• Intervention / Treatment: 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

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

  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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilie BRENAUT, Dr; Phone Number: +33 2 98 22 35 90; Email: emilie.brenaut@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHU Brest
    • Contact: Emilie BRENAUT, PhD; Phone Number: +33 2 98 22 35 90; Email: emilie.brenaut@univ-brest.fr ; emilie.brenaut@chu-brest.fr
    • Principal Investigator: emilie BRENAUT, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Case group (patient with sensitive scalp); 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.	Procedure: A 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; Other: a general health questionnaire; a general health questionnaire : demographics, history, treatment, smoking, alcohol consumption, phototype.; Other: 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); Procedure: Collection of skin microbiota; The skin microbiome is collected using a sterile swab rubbed against the scalp for 60 seconds
Other: Control group (patient with "normal" scalp); - A 'non-sensitive scalp' group, with a 3S score of 0.	Procedure: A 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; Other: a general health questionnaire; a general health questionnaire : demographics, history, treatment, smoking, alcohol consumption, phototype.; Procedure: Collection of skin microbiota; The skin microbiome is collected using a sterile swab rubbed against the scalp for 60 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 day
Study of innervation	1) 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)	1 day
Study of the skin microbiome	Quantification and characterization of microorganisms	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: September 2, 2025
• First Posted (Actual): September 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: sensitive scalp
• Other Study ID Numbers: 29BRC24.0318 - SENSISCALP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No