Assessing the Efficacy and Safety of Photobiomodulation for the Treatment of Pruritus
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peak Pruritus Numerical Rating Scale (PP-NRS)
研究概览
简要总结
This study is designed to evaluate the safety and effectiveness of a low-level near-infrared LED light device for relieving itch. The device is non-invasive, does not break the skin, and does not produce heat. Near-infrared light has been used in other medical settings and is known to interact with skin and nerve pathways. In this study, researchers are examining whether this light can be safely applied to the skin and whether it may help reduce itch by affecting signals involved in itch sensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Participant is an adult at least 18 years-of-age.
- •Participant meets the criteria for acute or chronic itch as defined below:
- •Acute itch lasting less than 6 weeks.
- •Chronic itch lasting more than 6 weeks.
- •Participant is able and willing to comply with all the study visit, treatment, and evaluation schedules and requirements.
- •Participant can understand and provide written informed consent.
- •Participant does not have any concurrent injury or wound in their target treatment area.
- •Participant is either untreated for their pruritus, or if on therapy, must have been maintained on a stable regimen of antipruritic treatments for the past 14 days prior to enrollment.
- •Participant has mild, moderate, or severe pruritus as defined below:
- •Mild: average score <4 on the PP-NRS during the week before baseline.
- •Moderate: average score 4-7 on the PP-NRS during the week before baseline.
- •Severe: average score of > 7 on the PP-NRS during the week before baseline.
- •Participants must have comparable pruritus affecting symmetrical or corresponding areas on both sides of their body to allow for the split-body study design.
排除标准
- •Participant has any active internal or cutaneous malignancy located within the proposed treatment area.
- •Participant cannot provide informed consent or adhere to study schedule.
- •Participant is actively tanning during the study course.
- •Participant has melasma or another condition exacerbated by heat.
- •Participant is on a photosensitizing medication, such as doxycycline or has a photosensitizing condition.
- •Patient is currently pregnant or breastfeeding.
- •Participant has psychogenic pruritus, a diagnosed skin-picking (excoriation) disorder, or any other current psychiatric condition that, in the investigator's judgment, could interfere with informed consent, adherence to the study protocol, or safe participation.
- •Participant has any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this study.
研究组 & 干预措施
Matching placebo
Matching placebo delivered by placing the device above the skin without activating it.
干预措施: Placebo (Other)
Low-Level Near-Infrared LED Light Treatment
Near-infrared light treatment will be administered to an area on the body experiencing itch.
干预措施: Light-emitting diode (LED) Photobiomodulation (PBM) device (Device)
结局指标
主要结局
Peak Pruritus Numerical Rating Scale (PP-NRS)
时间窗: Once daily for 7 days prior to the first treatment visit; each treatment visit; once daily for 7 days after the final treatment visit--Days -7~6, Days 13~20.
The primary endpoint is itch response, defined as a reduction of at least 2 points in the PP-NRS from baseline. The PP-NRS is an 11-point scale in which study participants are asked to rate their worst itch intensity during the previous 24 hours. Scores range from 0 to 10, with higher scores indicating more severe itch. 0 indicates no itch and 10 indicates the "worst itch imaginable." Participants will complete the PP-NRS daily and then we will calculate the average over 7 days preceding the study visit. Scores recorded at each treatment visit represent an average from the prior day. After the final treatment visit, participants will be asked again to complete a daily PP-NRS the next day, and then daily for the next 7 days. The score from the final treatment visit, as well as the average post-treatment score one week later will be compared to their average baseline score, with a change in PP-NRS from baseline by 2 or more representing a meaningful improvement.
次要结局
- Pruritus Numerical Rating Scale (P-NRS)(Twice per treatment visit (once immediately before treatment and once 10 minutes after treatment), Day 0~6.)
- Itchy Quality of Life (ItchyQoL)(During the first treatment visit, the final treatment visit, and the follow-up visit: Day 0, Day 6, Day 13.)
- Common Terminology Criteria for Adverse Events (CTCAE) version 5 Adverse Events(From Enrollment to Day 13.)
研究者
Richard Rox Anderson, MD
Director, Wellman Center for Photomedicine
Massachusetts General Hospital