Pathophysiological Study of the Sensitive Scalp

Not Applicable

Not yet recruiting

• Conditions: Sensitive Scalp

• Registration Number: NCT07156422
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study First Submitted: 2025-03-18
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Study the pathophysiology of the sensitive scalp based on a study of the genes expressed in the cutaneous tissue	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

Secondary Outcome Measures

Name	Time	Method
Histological study of skin tissue	1 day	1. 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 innervation	1 day	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)

Trial Locations

Locations (1)

Chu Brest; 🇫🇷 Brest, France