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Pathophysiological Study of the Sensitive Scalp (SENSISCALP)

R

Regional University Hospital Center (CHRU)

Status

Not yet enrolling

Conditions

Sensitive Scalp

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07156422
29BRC24.0318 - SENSISCALP

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Case group (patient with sensitive scalp)
Other group
Description:
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.
Treatment:
Other: Questionnaires concerning their sensitive scalp
Other: a general health questionnaire
Procedure: A scalp biopsy using a 4 mm punch in the retroauricular hair zone
Control group (patient with "normal" scalp)
Other group
Description:
\- A 'non-sensitive scalp' group, with a 3S score of 0.
Treatment:
Other: a general health questionnaire
Procedure: A scalp biopsy using a 4 mm punch in the retroauricular hair zone

Trial contacts and locations

1

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Central trial contact

Emilie BRENAUT, Dr

Data sourced from clinicaltrials.gov

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