Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05369338
Status:
COMPLETED
Last Update Posted:
2022-08-15
First Post:
2022-05-06
Brief Title:
The Effect of Low Level Light Therapy on Histamine- and Mucuna Pruriens-induced Pruritus in Healthy Volunteers
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None