Pathophysiological Study of the Sensitive Scalp

Overview

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

• 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

Primary outcome measures

• Study the pathophysiology of the sensitive scalp based on a study of the genes expressed in the cutaneous tissue [Time frame: 1 day]

Secondary outcome measures (3)

• Histological study of skin tissue [Time frame: 1 day]
• Study of innervation [Time frame: 1 day]
• Study of the skin microbiome [Time frame: 1 day]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 1 center

• Chu Brest — Brest

Identifiers

NCT: NCT07156422 · 29BRC24.0318 - SENSISCALP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗