Pathophysiological Study of the Sensitive Scalp

NCT ID: NCT07156422

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-10-31

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

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

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

Intervention Type: PROCEDURE

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

a general health questionnaire

Intervention Type: OTHER

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

Questionnaires concerning their sensitive scalp

Intervention Type: 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)

Control group (patient with "normal" scalp)

\- A 'non-sensitive scalp' group, with a 3S score of 0.

Group Type: OTHER

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

Intervention Type: PROCEDURE

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

a general health questionnaire

Intervention Type: OTHER

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

Interventions

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

Intervention Type: PROCEDURE

a general health questionnaire

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

Intervention Type: 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)

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Brest

Brest, , France

Countries

France

Central Contacts

Emilie BRENAUT, Dr

Role: CONTACT

emilie.brenaut@chu-brest.fr

2 98 22 35 90 ext. +33

Facility Contacts

Emilie BRENAUT, PhD

Role: primary

emilie.brenaut@univ-brest.fr ; emilie.brenaut@chu-brest.fr

2 98 22 35 90 ext. +33

Other Identifiers

29BRC24.0318 - SENSISCALP

Identifier Type: -

Identifier Source: org_study_id