Characterization of Bacterial and Mycosis Skin Flora in Seborrheic Macular Hypopigmentation - Microbiome_SHM
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
The study population will consist of adult subjects (≥ 18 years) with Seborrheic Macular Hypopigmentation.
干预措施: Skin's lesion patients (Other)
Vulunteers
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)
