Pilot Study to Characterize the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of CLn® Skin Care Body Wash
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Reduction of S. aureus skin microbiome
研究概览
简要总结
In this pilot study of patients with mycosis fungoides, the most common form of CTCL, we propose to primarily evaluate the impact of daily use of the CLn Body Wash (dilute sodium hypochlorite (0.006% NaOCl)) on the microbiota of CTCL lesions. Should dilute sodium hypochlorite body wash improve the microbiome of MF, reducing the abundance of S. aureus, future, larger studies can more fully evaluate the impact on pruritus, erythema, scaling, disease evolution and its role in CTCL management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18-89 years of age with active mycosis fungoides.
- •Patients with concurrent and prior malignancies are allowed as long as any concurrent malignancy does not directly involve the same skin site.
排除标准
- •Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics, pregnant persons, or persons with potential of becoming pregnant or are/will be breastfeeding
- •Patients that have initiated a new skin-directed therapy over the past month.
研究组 & 干预措施
Mycosis Fungoides patients
Patients with mycosis fungoides will be enrolled at Northwestern Memorial Hospital Dermatology
干预措施: CLn Body Wash (Other)
结局指标
主要结局
Reduction of S. aureus skin microbiome
时间窗: 8 weeks
Reduction of S. aureus relative abundance between baseline (Week 0) and Week 8.
Change of S. aureus skin microbiome
时间窗: 8 weeks
Change of S. aureus relative abundance between baseline (Week 0) and Week 8.
次要结局
未报告次要终点
研究者
Xiaolong (Alan) Zhou
Principal Investigator
Northwestern University