NL-OMON54897尚未招募4 期
Intralesional bleomycin treatment of keloids using an electronic pneumatic jet injector: a double-blind randomized, placebo-controlled trial with split-lesion design - Bleomycin jet injections in keloids
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject has provided written informed consent;
- •2. Subject is >= 18 years of age at time of screening;
- •3. Subject has at least one keloid scar of >= 4 cm in length, or two separate
- •keloids with a length of >=2cm, with a minimum > 1.0 cm apart in the same
- •anatomical region.
- •4. Subject is willing to fill in questionnaires and take photos using an
- •e-diary application on a smartphone.
排除标准
- •1. Known hypersensitivity to any component of the test materials;
- •2. Pregnant or breast-feeding women (beta-HCG test prior to treatment);
- •3. Previous bleomycin treatment of the keloid within the last 12 weeks prior to
- •4. Non-response to previous bleomycin treatments of the keloid.
- •5. Any medical or psychiatric condition which, in the investigator's opinion,
- •would preclude the participant from adhering to the protocol or completing the
- •study per protocol.
研究者
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