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NCT Number: NCT07156422

Pathophysiological Study of the Sensitive Scalp

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.

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Key information

Conditions

Sensitive Scalp

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

a general health questionnaire

Other

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

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)

Collection of skin microbiota

Procedure

The skin microbiome is collected using a sterile swab rubbed against the scalp for 60 seconds

Primary outcomes

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

    Time frame: 1 day

    • 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

Secondary outcomes

  1. Histological study of skin tissue

    Time frame: 1 day

    • 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)

  2. Study of innervation

    Time frame: 1 day

    • 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)

  3. Study of the skin microbiome

    Time frame: 1 day

    Quantification and characterization of microorganisms

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie BRENAUT, Dr

CONTACT

[email protected]

2 98 22 35 90 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: SENSISCALP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.