NCT05728879尚未招募早期 1 期
Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in microbiome species
研究概览
简要总结
This open-label, pilot study will evaluate the tolerance and change in the microbiome from the use of APR-TD011 ((RLF-TD011) wound cleansing spray for the treatment of CTCL skin lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Adults with early-stage mycosis fungoides (stages IA-IB)
- •At least two target lesions that have been present for at least 3 weeks and is at least 10 cm2 , so that at least one lesion may be allocated to each of the treatment regimes
- •Target lesion with swab that is culture positive for staphylococcus aureus, but not to an extent that would require systemic antibiotics
- •Agree to avoid washing or using a topical application at the target lesion starting the night before each scheduled study visit.
- •Agree for the duration of study participation to avoid using dilute bleach or vinegar baths, or other antiseptic use, at the target lesion from screening throughout the study.
排除标准
- •Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics adults unable to provide informed consent, (infants, children, teenagers, pregnant women, prisoners and other vulnerable populations.
研究组 & 干预措施
CTCL participants
Experimental
Visits will include screening, pre-treatment (week 0), weeks 4 and 8.
干预措施: APR-TD011 (RLF-TD011) (Combination Product)
结局指标
主要结局
Change in microbiome species
时间窗: 4 weeks
Reduction of Staphylococcus aureus relative abundance between baseline and Week 4
次要结局
未报告次要终点
研究者
Xiaolong (Alan) Zhou
Principal Investigator
Northwestern University
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Characterization of the Microbiome in Cutaneous T Cell LymphomaCutaneous T Cell LymphomaNCT03932279Northwestern University300
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 WashCutaneous T Cell LymphomaNCT06665490Northwestern University15
Unknown
不适用
Study of the Skin Microbiome and the Potential of a Topical Probiotic Cream for Atopic DermatitisAtopic DermatitisNCT04771910University Hospital, Antwerp40
已完成
不适用
Exploration of the modulation of skin microbiota and odor components by introduction of stress in healthy male subjects.Stress-induced malodor formationMalodorSweat odorNL-OMON44360Procter & Gamble30
已完成
4 期
Profiling the Skin Microbiome in Response to Altreno in Acne PatientsHealthyAcneNCT04548349Beth Israel Deaconess Medical Center25