PruritusEarly Phase 1NCT07450716
Assessing the Efficacy and Safety of Photobiomodulation for the Treatment of Pruritus
A Early Phase 1 study testing Light-emitting diode (LED) Photobiomodulation (PBM) device in people with Pruritus, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus
- What is being tested?
- Light-emitting diode (LED) Photobiomodulation (PBM) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, 02115
Clinical Research Coordinator, 617-724-2168, wellmancrc@partners.org
Margaret Chou, MD
About this study
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.
- Conditions
- Pruritus
- Being tested
- Light-emitting diode (LED) Photobiomodulation (PBM) device, Placebo
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light-emitting diode (LED) Photobiomodulation (PBM) deviceDevice
Near-infrared light treatment will be administered to an area on the body experiencing itch.
PlaceboOther
Matching placebo delivered by placing the device above the skin on an area contralateral to the treatment area without activating it.
| Study group | Role | What they receive |
|---|---|---|
| Matching placebo | Placebo comparator | Matching placebo delivered by placing the device above the skin without activating it. Receives: Other: Placebo |
| Low-Level Near-Infrared LED Light Treatment | Experimental | Near-infrared light treatment will be administered to an area on the body experiencing itch. Receives: Device: Light-emitting diode (LED) Photobiomodulation (PBM) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From Enrollment to Day 13.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
- Investigators
- Richard R. Anderson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450716
- Sponsor's protocol ID
- 2025P003440
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Safety of Photobiomodulation for the Treatment of Pruritus
- ClinicalTrials.gov ID
- NCT07450716
- Acronym / sponsor ID
- 2025P003440
- Conditions
- Pruritus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matching placebo | Placebo comparator | Other: PlaceboMatching placebo delivered by placing the device above the skin without activating it. |
| Low-Level Near-Infrared LED Light Treatment | Experimental | Device: Light-emitting diode (LED) Photobiomodulation (PBM) deviceNear-infrared light treatment will be administered to an area on the body experiencing itch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participant is an adult at least 18 years-of-age.
- Participant meets the criteria for acute or chronic itch as defined below:
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light-emitting diode (LED) Photobiomodulation (PBM) deviceNear-infrared light treatment will be administered to an area on the body experiencing itch. | Device | Low-Level Near-Infrared LED Light Treatment |
| PlaceboMatching placebo delivered by placing the device above the skin on an area contralateral to the treatment area without activating it. | Other | Matching placebo |
Primary outcome
Peak Pruritus Numerical Rating Scale (PP-NRS)
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.
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.
3 secondary outcomes
Pruritus Numerical Rating Scale (P-NRS)
Time frame: Twice per treatment visit (once immediately before treatment and once 10 minutes after treatment), Day 0~6.
Itchy Quality of Life (ItchyQoL)
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
Time frame: From Enrollment to Day 13.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard R. Anderson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Light-emitting diode (LED) Photobiomodulation (PBM) device in people with Pruritus, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (617-724-2168, wellmancrc@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Pruritus Numerical Rating Scale (PP-NRS) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.