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临床试验/NCT07156422
NCT07156422招募中不适用

Pathophysiological Study of the Sensitive Scalp

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Study the pathophysiology of the sensitive scalp based on a study of the genes expressed in the cutaneous tissue

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Histological and innervation analyses will be carried out in a blinded fashion.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

Case group (patient with sensitive scalp)

Other

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.

干预措施: Questionnaires concerning their sensitive scalp (Other)

Control group (patient with "normal" scalp)

Other

- A 'non-sensitive scalp' group, with a 3S score of 0.

干预措施: A scalp biopsy using a 4 mm punch in the retroauricular hair zone (Procedure)

Control group (patient with "normal" scalp)

Other

- A 'non-sensitive scalp' group, with a 3S score of 0.

干预措施: Collection of skin microbiota (Procedure)

Case group (patient with sensitive scalp)

Other

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.

干预措施: A scalp biopsy using a 4 mm punch in the retroauricular hair zone (Procedure)

Case group (patient with sensitive scalp)

Other

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.

干预措施: a general health questionnaire (Other)

Control group (patient with "normal" scalp)

Other

- A 'non-sensitive scalp' group, with a 3S score of 0.

干预措施: a general health questionnaire (Other)

Case group (patient with sensitive scalp)

Other

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.

干预措施: Collection of skin microbiota (Procedure)

结局指标

主要结局

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

时间窗: 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

次要结局

  • Histological study of skin tissue(1 day)
  • Study of innervation(1 day)
  • Study of the skin microbiome(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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