An Early Phase 1 interventional study of Light-emitting diode (LED) Photobiomodulation (PBM) device and Placebo in Pruritus, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Treatment
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.
490 studies on the registry are indexed under Pruritus; 93 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 422 interventional studies indexed under Pruritus.
Browse Pruritus studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant meets the criteria for acute or chronic itch as defined below:
Participant has mild, moderate, or severe pruritus as defined below:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Matching placebo delivered by placing the device above the skin without activating it.
Other: Placebo
Near-infrared light treatment will be administered to an area on the body experiencing itch.
Device: Light-emitting diode (LED) Photobiomodulation (PBM) device
Near-infrared light treatment will be administered to an area on the body experiencing itch.
Matching placebo delivered by placing the device above the skin on an area contralateral to the treatment area without activating it.
Peak Pruritus Numerical Rating Scale (PP-NRS)
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.
Time frame: 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.
Pruritus Numerical Rating Scale (P-NRS)
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.
Time frame: Twice per treatment visit (once immediately before treatment and once 10 minutes after treatment), Day 0~6.
Itchy Quality of Life (ItchyQoL)
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.
Time frame: 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
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.
Time frame: From Enrollment to Day 13.
Start is estimated for Apr 2026; primary completion for Dec 2026, 8 months later.
Of 21 phase 1 interventional studies under Pruritus, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 14. This study's planned 8 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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