Assessing the Efficacy and Safety of Photobiomodulation for the Treatment of Pruritus
ConditionPruritus
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is an adult at least 18 years-of-age.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Light-emitting diode (LED) Photobiomodulation (PBM) device
DeviceNear-infrared light treatment will be administered to an area on the body experiencing itch.
Placebo
Other interventionMatching placebo delivered by placing the device above the skin on an area contralateral to the treatment area without activating it.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Matching placeboPlacebo comparator 1 intervention
Group B: Low-Level Near-Infrared LED Light TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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 0~6.2
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 13.3
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.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: