Assessing the Efficacy and Safety of Photobiomodulation for the Treatment of Pruritus

Обзор

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.

Вмешательства

• Устройство Light-emitting diode (LED) Photobiomodulation (PBM) device
  Near-infrared light treatment will be administered to an area on the body experiencing itch.
• Другое Placebo
  Matching placebo delivered by placing the device above the skin on an area contralateral to the treatment area without activating it.

Первичные конечные точки

• Peak Pruritus Numerical Rating Scale (PP-NRS) [Срок оценки: 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.]

Вторичные конечные точки (3)

• Pruritus Numerical Rating Scale (P-NRS) [Срок оценки: Twice per treatment visit (once immediately before treatment and once 10 minutes after treatment), Day 0~6.]
• Itchy Quality of Life (ItchyQoL) [Срок оценки: 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 [Срок оценки: From Enrollment to Day 13.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Wellman Center for Photomedicine, Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07450716 · 2025P003440

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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