Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata: a Pilot Study of Patient Tolerability
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Determine Patient Tolerability of Needle-free Delivery of Intralesional Triamcinolone Using the Patient-reported Outcomes of a Pain Score Assessment and a Patient Survey.
研究概览
简要总结
This is an interventional pilot study assessing the tolerability of needle-free delivery administration of ILTA with the Med-Jet as an alternative to conventional syringe and needle in patients with patchy pediatric alopecia areata. There will be a total of four (4) or five (5) visits necessary for study participation. The investigators hypothesize that the Med-Jet will have acceptable pain tolerability, efficacy, safety, and a positive impact on patient quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with alopecia areata by either:
- •A board-certified dermatologist, OR
- •Dermatology Nurse Practitioner, OR
- •Skin punch biopsy
- •Patient has at least 2 alopecic patches each measuring at least 2 cm2 and are...
- •Located on contralateral body sites OR
- •Within the same body site but separated by ≥ 1 cm
- •Patient is a candidate for intralesional triamcinolone.
- •Patient able to give informed assent under IRB approval procedures when appropriate.
- •At least one parent or guardian is able to provide informed consent.
排除标准
- •Patient has alopecia totalis, alopecia universalis, or alopecia areata with ophiasis pattern.
- •Known allergy or hypersensitivity to triamcinolone acetonide
- •Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
- •Patient is unable/unwilling to provide informed assent when applicable.
- •Known medical diagnosis or use of a medication that alters pain response at time of injection.
- •Active infection at site designated for injection.
- •If currently being treated for alopecia areata, the current treatment regimen has been started within less than 4 weeks of screening.
研究组 & 干预措施
MedJet Device
The Med-Jet-MBX needle-free injector (Med-Jet) is a novel, needle-free drug-delivery system, which we believe may be a solution to the pain and fear associated with needles. It uses regulated compressed air as a power source to accelerate an injectable fluid through a 0.005" orifice (6x smaller than a 30G needle) to penetrate the skin and deliver medication to a specific anatomical region (MedJet) The drug-delivery device is highly configurable allowing adjustable depth and volume parameters (MedJet). In addition, the high-performance design allows for triggering multiple injection sites rapidly which is practical when needing to treat large surface areas (MedJet).
干预措施: MedJet Device with intralesional triamcinolone (Combination Product)
结局指标
主要结局
Determine Patient Tolerability of Needle-free Delivery of Intralesional Triamcinolone Using the Patient-reported Outcomes of a Pain Score Assessment and a Patient Survey.
时间窗: 12 weeks
For the pain score assessment, patients will rate their pain from the needle-free injection using the Wong-Baker FACES Scale and a numerical rating scale, in which score ranges from 0-10 where 0 is no pain and 10 is the worst pain imaginable.
次要结局
- Change in Alopecia Areata- Investigator Global Assessment (AA-IGA)(Baseline (Pre-treatment), 12 weeks (Post-treatment))
- Change in Patient Reported Hair Loss(Baseline (pre-treatment), 12 weeks (post-treatment))
- Change in Severity of Alopecia Tool (SALT) Score(Baseline (Pre-treatment), 12 weeks (Post-treatment))
- Hair Regrowth of Treated Patch(12 weeks)
- Hair Regrowth of Non-treated Patch(12 weeks)
- Determine the Impact of Needle-free Delivery of Intralesional Triamcinolone on Quality of Life for Pediatric Alopecia Areata Using a Quality of Life Assessment.(Baseline (pre-treatment), 12 weeks (post-treatment))
- Patient Reported Hair Regrowth(12 weeks)