Pathophysiological Study of the Sensitive Scalp

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Другое a general health questionnaire
  a general health questionnaire : demographics, history, treatment, smoking, alcohol consumption, phototype.
• Другое 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)
• Процедура Collection of skin microbiota
  The skin microbiome is collected using a sterile swab rubbed against the scalp for 60 seconds

Первичные конечные точки

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

Вторичные конечные точки (3)

• Histological study of skin tissue [Срок оценки: 1 day]
• Study of innervation [Срок оценки: 1 day]
• Study of the skin microbiome [Срок оценки: 1 day]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Chu Brest — Brest

Идентификаторы

NCT: NCT07156422 · 29BRC24.0318 - SENSISCALP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗