The Effect of Low Level Light Therapy on Histamine- and Mucuna Pruriens-induced Pruritus in Healthy Volunteers

The Effect of Low Level Light Therapy on Histamine- and Mucuna Pruriens-induced Pruritus in Healthy Volunteers: A Prospective, Double-blind, Randomised Sham-controlled Pilot Study

This is a prospective, double-blind, randomised, sham-controlled study whose primary aim is to test whether LLLT changes the intensity of itch after histamine application in healthy volunteers compared to sham application.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Low Level Light Therapy; Device: Sham Controll

Detailed Description

Rationale and relevance of the study

Low-level light therapy (LLLT) is a method of photobiomodulation that involves the clinical application of light with wavelengths typically in the range of 600 to 1100 nm and with a typical power density of 5 mWcm² to 5 Wcm².

Clinical studies have demonstrated positive effects of LLLT on pain processing, which is attributed to a reduction in neurogenic inflammation and associated neuronal sensitisation. This has been proven by testing for hyperaesthesia or allodynia. In the course of neurogenic inflammation, histamine liberation also occurs, which can be associated with itching. Chronic itching is also frequently associated with somatosensory abnormalities in analogy to chronic pain. Itch-associated dysaesthesias, such as mechanical allocnesia and hyperknesia, can be seen as evidence of neuronal sensitisation in pruritus patients.

Oliviera et al. were able to demonstrate an antipruritic effect of LLLT in a case observation of five burn victims. By irradiating with laser, whose photobiomodulative mechanisms are similar to the mechanisms of LLL therapy, this effect was also investigated in lichen planus patients. The effect of LLL on pruritus can be demonstrated in the case observation of five burn victims.

Itch models can be divided into histamine-induced and non-histamine-induced. To date, there has been no structured investigation of the antipruritic effect of LLL, nor is it clear to what extent the itch-inducing mechanism has an influence on the suspected efficacy of LLL.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent of the participant
• Healthy test persons aged 18-60
• For female volunteers, negative pregnancy test

Exclusion Criteria:

• known allergy or hypersensitivity to histamine or the Mucuna pruriens
• history of skin diseases
• tattoos in the test area
• neoplasia in the test area
• pacemaker
• pregnancy
• epilepsy
• piercings
• fever
• local acute infection, skin inflammation/rashes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low Level Light Therapy; The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring.	Device: Low Level Light Therapy; The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring. The sham treatment is performed with the same device and the same distance ring without activating it.; Other Names: LLLT
SHAM_COMPARATOR: Sham controll; The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring. The sham treatment is performed with the same device and the same distance ring without activating it.	Device: Sham Controll; The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring. The sham treatment is performed with the same device and the same distance ring without activating it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus Intensity	Histaminergic itch is determined using a visual analogue scale (0-100) The non-histaminergic itch is determined by means of a visual analogue scale (0-100).	2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurogenic inflammation	The neurogenic inflammation of histaminergic itch is determined by recording the flare area and measuring the skin temperature. The neurogenic inflammation of non-histaminergic itch is determined by recording the flare area and measuring the skin temperature.	10 minutes
Alloknesia	an area of alloknesia will be tested in the histaminergic itch model using cotton swabs. an area of alloknesia is tested in the non-histaminergic itch model using cotton swabs.	10 minutes
Hyperknesia	a hyperkneesia area is tested in the histaminergic itch model using a von Frey filament. a hyperkneesia area is tested in the non-histaminergic itch model using a von Frey filament.	10 minutes

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 6, 2022
• Primary Completion (ACTUAL): August 4, 2022
• Study Completion (ACTUAL): August 4, 2022

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (ACTUAL): May 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: 33-431 ex 21/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No