NCT05533866已完成早期 1 期
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in microbiome species
研究概览
简要总结
In this pilot study, APR-TD011 antimicrobial wound cleansing spray will be given to all enrolled patients with junctional EB (JEB) or dystrophic epidermolysis bullosa (DEB) with Staphylococcus aureus or Pseudomonas aeruginosa culture-positive wounds. The primary aim will be to evaluate the change in skin microbiome (S. aureus, P. aeruginosa, commensal organisms) before, during, after treatment. Subjects who are colonized by S. aureus or pseudomonas will be treated for 8 weeks, will stop the spray and return at 12 weeks (4 weeks without the spray), and then will be able to use the spray as desired in a 6-month period of open-label use, with further feedback collected.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 6 months of age or above with junctional or dystrophic epidermolysis bullosa
- •Target wound that has been present for at least 3 weeks and is at least 10 cm2
- •Target wound that is colonized with Staphylococcus aureus and/or Pseudomonas aeruginosa
排除标准
- •Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics
- •Do not agree to avoid bathing or topical application at the target starting the night before the visit.
- •Do not agree to avoid dilute bleach or vinegar baths, or other antiseptic use, at the target site starting at screening throughout the study.
结局指标
主要结局
Change in microbiome species
时间窗: 8 weeks
Reduction of Staphylococcus aureus between baseline and Week 8.
次要结局
未报告次要终点
研究者
Amy Paller
Principal Investigator
Northwestern University
研究点 (2)
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相关资讯
FDA Grants Rare Pediatric Disease Designation to Relief Therapeutics' EB Treatment RLF-TD011- The FDA has granted Rare Pediatric Disease designation to Relief Therapeutics' RLF-TD011 for epidermolysis bullosa, a rare genetic skin disorder affecting approximately 500,000 people worldwide.
- RLF-TD011 is a hypotonic acid-oxidizing solution with hypochlorous acid that provides antimicrobial and anti-inflammatory properties while creating a wound microenvironment conducive to healing.
- The designation could potentially lead to a Priority Review Voucher upon approval, which has significant value as demonstrated by a recent EB treatment voucher that sold for $155 million.last yearRLF-TD011 Spray Shows Promise in Healing Epidermolysis Bullosa Wounds• RLF-TD011, a hypochlorous acid spray, effectively reduced harmful bacteria in epidermolysis bullosa wounds in a Phase 1 trial.
• The treatment led to a 24% reduction in _Staphylococcus aureus_ and improved wound closure in treated patients over eight weeks.
• Researchers observed a more diverse and beneficial wound microbiome following treatment, suggesting a lasting positive effect.
• Relief Therapeutics plans to consult with the FDA to finalize the regulatory plan for RLF-TD011, which has orphan drug designation.last year