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

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Low Level Light Therapy
Sham Controll
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Volunteers

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical university of Graz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Low Level Light Therapy

Sham controll

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 6, 2022
Last Updated
August 12, 2022
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT05369338
Brief Title
The Effect of Low Level Light Therapy on Histamine- and Mucuna Pruriens-induced Pruritus in Healthy Volunteers
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
August 4, 2022 (Actual)
Study Completion Date
August 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective, double-blind, randomised, sham-controlled
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The subjects are blinded to the irradiation side by audiovisual masking (swimming goggles with blackened lenses, hearing protection). The subjects do not have access to the randomisation list and are not in the same room during the irradiation. This means that they are also blinded to the irradiation side.
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Level Light Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham controll
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Low Level Light Therapy
Other Intervention Name(s)
LLLT
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Controll
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pruritus Intensity
Description
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).
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Neurogenic inflammation
Description
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.
Time Frame
10 minutes
Title
Alloknesia
Description
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.
Time Frame
10 minutes
Title
Hyperknesia
Description
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.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Medical university of Graz
City
Graz
ZIP/Postal Code
8010
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

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

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