跳至主要内容
临床试验/NCT06665490
NCT06665490
Enrolling By Invitation
不适用

Pilot Study to Characterize the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of CLn® Skin Care Body Wash

Northwestern University2 个研究点 分布在 1 个国家目标入组 15 人2025年1月14日

概览

阶段
不适用
干预措施
CLn Body Wash
疾病 / 适应症
Cutaneous T Cell Lymphoma
发起方
Northwestern University
入组人数
15
试验地点
2
主要终点
Reduction of S. aureus skin microbiome
状态
Enrolling By Invitation
最后更新
昨天

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.

注册库
clinicaltrials.gov
开始日期
2025年1月14日
结束日期
2027年12月1日
最后更新
昨天
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Xiaolong (Alan) Zhou

Principal Investigator

Northwestern University

入排标准

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

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.

研究点 (2)

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