跳至主要内容
临床试验/NCT06908889
NCT06908889招募中不适用

Characterization of Bacterial and Mycosis Skin Flora in Seborrheic Macular Hypopigmentation - Microbiome_SHM

Centre Hospitalier Universitaire de Nice3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月25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
20
试验地点
3
主要终点
The bacterial skin microbiome of SMH patients vs voluntheers

研究概览

简要总结

Hypopigmented skin changes are commonly encountered by dermatologists. A new dermatological entity was identified as scattered, hypopigmented oval-shaped macules and patches distributed mostly in seborrheic area of the face and of the trunk in dark skinned individuals. This patterned presentation of hypopigmentation was first described in the literature under the name of hypochromic vitiligo or vitiligo minor. Nerveless, histopathological patient's specimens analyzed by Krueger et al. clearly highlight that there is no tangible causal correlation with a diagnosis of vitiligo. They propose to rename this entity to Seborrheic Macular Hypopigmentation (SMH). The etiopathology of this dermatosis is still unknown preventing to propose any satisfactory treatment for this disfiguring affection.The objective of this study is to analyze the bacterial and fungal skin microbiome on hypochromic lesions of SMH compared to the surrounding non-lesional skin of the same patients and to healthy volunteers

研究设计

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

入排标准

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

入选标准

  • •Female and male patients ≥ 18 years of age
  • •Clinical diagnosis of SMH with lesion of the face
  • •Written informed consent obtained before any assessment is performed
  • •Affiliation with a social security scheme
  • •Physical and psychological ability to participate

排除标准

  • •Use of systemic antibiotics or any systemic antifungal treatments within 4 weeks before the inclusion visit
  • •Use of topical antibiotics or any topical antifungal treatments on the face within 2 weeks before the inclusion visit
  • •Use of any topical cream, gel, serum or ointment within 2 days before the inclusion visit
  • •Laser, radiofrequency, peeling or any other procedure on the face in the past 3 months before the inclusion visit
  • •Vulnerable patients: minors, patients under guardianship or curatorship, pregnant or breast-feeding women

研究组 & 干预措施

Patients

Other

The study population will consist of adult subjects (≥ 18 years) with Seborrheic Macular Hypopigmentation.

干预措施: Skin's lesion patients (Other)

Vulunteers

Other

Volunteers will be included once the required number of SMP patients has been attained. Volunteers are going to be recruited only at the coordinator center, the CHU of Nice. Recruitment will be communicated to medical and/or Inserm staff, via an announcement in the respective departments.

干预措施: Skin's lesion vulunteers (Other)

结局指标

主要结局

The bacterial skin microbiome of SMH patients vs voluntheers

时间窗: at baseline

For each sample, the bacterial profiles determined by real time PCR, will be described and compared as follows: seborrheic macular hypopigmented lesions versus same anatomic area in healthy volunteers.

次要结局

  • The bacterial skin microbiome of SMH patients compare to the non-lesional surrounded skin of the same patients.(at baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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