Pathophysiological Study of the Sensitive Scalp

NCT07156422 | Recruiting

• 1 other identifier: 29BRC24.0318 - SENSISCALP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensitive Scalp

Keywords

sensitive scalp

Outcome Measures

Primary Outcomes (1)

• Study the pathophysiology of the sensitive scalp based on a study of the genes expressed in the cutaneous tissue

  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

  1 day

Secondary Outcomes (2)

• Histological study of skin tissue

  1 day

• Study of innervation

  1 day

Study Arms (2)

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.

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

Control group (patient with "normal" scalp)

OTHER

\- 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; Other: a general health questionnaire

Interventions

a general health questionnaire OTHER

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

Case group (patient with sensitive scalp); Control group (patient with "normal" scalp)

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

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

Case group (patient with sensitive scalp); Control group (patient with "normal" scalp)

Questionnaires concerning their sensitive scalp OTHER

* 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)

Case group (patient with sensitive scalp)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29200, France

RECRUITING

Central Study Contacts

Emilie BRENAUT, Dr

CONTACT

2 98 22 35 90; emilie.brenaut@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Histological and innervation analyses will be carried out in a blinded fashion.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: case-control study

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: September 5, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• 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.

Locations

FR (1)