NCT05971381已完成不适用
The TONE Study: A Prospective Post-Market Clinical Study Investigating Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 32
- 主要终点
- Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%)
研究概览
简要总结
To evaluate repigmentation and quality of life after treatment of stable vitiligo lesions using the RECELL Device.
详细描述
Prospective, multicenter single-arm pre-/post interventional study to evaluate the clinical performance of RECELL for repigmentation of stable depigmented lesions.Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.
Repigmentation of treatment areas will be determined via centralized image interpretation by an expert dermatological panel (i.e., Central Review Committee, CRC).
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
- •Focal, segmental, or generalized (i.e., nonsegmental) stable vitiligo, defined as no new depigmented areas nor any depigmented areas that have expanded in size within the preceding 12 months.
- •The patient is a candidate for surgical intervention of a depigmented area, defined as a patient who has not satisfactorily responded to either:
- •topical therapy or
- •a minimum of 3 months of phototherapy.
- •The patient has a depigmented area available for treatment that is:
- •≥90% depigmented,
- •without any other dermatologic conditions (other than vitiligo), and
- •excludes the lips, eyelids, plantar surface of feet, palmar surface of hands.
- •The patient is 18 years of age or older.
- •The patient agrees to remain on any current use of immunosuppressive therapy for the duration of his/her participation in the study (52 weeks).
- •The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up study visits.
- •The patient agrees to abstain from any other treatment of the study area for the duration of his/her participation in the study (52 weeks).
- •The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation in the study (52 weeks).
- •In the opinion of the investigator, the patient must be able to:
- •Understand the full nature and purpose of the study, including possible risks and benefits,
- •Understand instructions and be able to comprehend and complete study questionnaires, and
- •Provide voluntary written informed consent. -
排除标准
- •The patient is unable to undergo treatment area preparation.
- •Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP
- •Patients with:
- •depigmented lips and fingertips (lip-tip vitiligo), or
- •depigmented areas over >30% of their body surface area.
- •Patients with recent history (within previous 12 months) of:
- •Koebnerization,
- •confetti-like, or
- •trichrome lesions.
- •Patients with a history of keloid formation.
- •The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
- •Current use of medications (e.g., anticoagulants such as heparin or warfarin) that in the investigator's opinion may compromise patient safety or trial objectives.
- •The patient has a known hypersensitivity to trypsin, compound sodium lactate for irrigation solution (Hartmann's solution), povidone-iodine, chlorhexidine, and/or lidocaine-containing anesthetics -
结局指标
主要结局
Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%)
时间窗: 24 weeks post-treatment
Central Review Committee categorization of index area repigmentation
次要结局
未报告次要终点
研究者
研究点 (32)
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