Pruritus
Conditions
Brief summary
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.
Interventions
DEVICELight-emitting diode (LED) Photobiomodulation (PBM) device
Near-infrared light treatment will be administered to an area on the body experiencing itch.
OTHERPlacebo
Matching placebo delivered by placing the device above the skin on an area contralateral to the treatment area without activating it.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant is an adult at least 18 years-of-age. 2. Participant meets the criteria for acute or chronic itch as defined below: 1. Acute itch lasting less than 6 weeks. 2. Chronic itch lasting more than 6 weeks. 3. Participant is able and willing to comply with all the study visit, treatment, and evaluation schedules and requirements. 4. Participant can understand and provide written informed consent. 5. Participant does not have any concurrent injury or wound in their target treatment area. 6. 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. 7. Participant has mild, moderate, or severe pruritus as defined below: 1. Mild: average score \<4 on the PP-NRS during the week before baseline. 2. Moderate: average score 4-7 on the PP-NRS during the week before baseline. 3. Severe: average score of \> 7 on the PP-NRS during the week before baseline. 8. Participants must have comparable pruritus affecting symmetrical or corresponding areas on both sides of their body to allow for the split-body study design.
Exclusion criteria
1. Participant has any active internal or cutaneous malignancy located within the proposed treatment area. 2. Participant cannot provide informed consent or adhere to study schedule. 3. Participant is actively tanning during the study course. 4. Participant has melasma or another condition exacerbated by heat. 5. Participant is on a photosensitizing medication, such as doxycycline or has a photosensitizing condition. 6. Patient is currently pregnant or breastfeeding. 7. 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. 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Pruritus Numerical Rating Scale (PP-NRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pruritus Numerical Rating Scale (P-NRS) | Twice per treatment visit (once immediately before treatment and once 10 minutes after treatment), Day 0~6. | The Pruritus Numerical Rating Scale (P-NRS) is a validated, patient-reported instrument for assessing itch severity. It provides a simple, quantitative measure of pruritus at a given point in time. In this study, the P-NRS will be administered immediately before and 10 minutes after each intervention session. Scores range from 0 (no itch) to 10 (very severe itch), categorized as follows: 1-3 = mild, 4-6 = moderate, 7-8 = severe, and 9-10 = very severe itch. A reduction of 2 to 4 points from baseline is considered clinically meaningful. |
| 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. | ItchyQoL is a validated, patient-reported outcome measure designed to assess the impact of chronic pruritus on quality of life across three domains: symptoms, functional limitations, and emotional well-being. The instrument includes 22 items rated on a 5-point Likert scale (0 = never to 4 = all the time), with higher scores indicating greater pruritus-related impairment. Each answer is graded on a five-point scale, with higher total scores indicating greater pruritus-related quality of life impairment. |
| Common Terminology Criteria for Adverse Events (CTCAE) version 5 Adverse Events | From Enrollment to Day 13. | The toxicity of grading will be assessed as per the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Any AEs will be rated from not present (\<grade 1) to present and mild (grade 1) to severe and requiring intervention (grade 4). For each of these categories, \> grade 2 requires treatment or impacts activities of daily living. AEs will be assessed based on interview +/- photography at baseline, all treatment visits, as well as 1 week after the last treatment. The frequency and severity of all AEs deemed at least possibly related to the treatment or placebo modality will be recorded. |
Countries
United States
Contacts
CONTACTClinical Research Coordinator
CONTACTMargaret Chou, MD
PRINCIPAL_INVESTIGATORRichard R. Anderson, MD
Massachusetts General Hospital
Outcome results
None listed