Ignite Creation Date:
2024-05-06 @ 9:59 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03132142
Status:
UNKNOWN
Last Update Posted:
2017-04-27
First Post:
2017-04-25
Brief Title:
Desensitization of Nociceptive Afferents by Application of Topical Capsaicin Trans-cinnamaldehyde and L-menthol
Sponsor:
Aalborg University
Organization:
Aalborg University
Study Overview
Official Title:
Temporal Profile of the Nociceptive Desensitization Induced by 8 Topical Capsaicin and the Functional Independence of Transient Receptor Potential Ankyrin 1 TPRA1- and Vanilloid 1 TRPV1-Expressing Nociceptive Afferents
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
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:
The purpose of this study is to investigate the potential desensitising effects of repeated applications of capsaicin trans-cinnamaldehyde and L-menthol on thermal mechanical and chemical sensory stimulations
Detailed Description:
Capsaicin the compound responsible for the pungency of chili peppers can induce desensitization to nociceptive 1 and pruriceptive 2 stimuli when topically applied The purpose of this study is to determine whether repeated topical applications of trans-cinnamaldehyde and L-menthol result in decreased responses to various nociceptive and non-nociceptive thermal and mechanical stimuli and to compare potential alterations with those caused by repeated topical application of capsaicin Furthermore this study investigates the temporal profile of said alterations
Capsaicin 8 patches trans-cinnamaldehyde 10 L-menthol 40 and inert vehicle patches will each be applied to 4 4x4 cm predefined areas on the skin of the volar forearms for 1 hour 4 times on 4 consecutive days Before each application and the day after the last application cold detection threshold CDT warmth detection threshold WDT cold pain threshold CPT and heat pain threshold HPT will be assessed using a Medoc Pathway Medoc Israel equipped with a 3x3 cm contact thermode On the last day mechanical detection threshold MDT is assessed using a series of von Frey filaments and mechanical pain threshold MPT and mechanical pain sensitivity MPS is assessed using a series of standardized pinprick stimulators Aalborg University
Furthermore full-field laser perfusion imaging FLPI will be used to assess the degree of neurogenic inflammation in each predefined area before and after each substance application and at the last session
1 F Henrich et al 2015 Capsaicin-sensitive C- and A-fibre nociceptors control long-term potentiation-like pain amplification in humans
2 HH Andersen et al 2017 Antipruritic effect of pretreatment with 8 topical capsaicin on histamine- and cowhage-evoked itch in healthy volunteers - a randomized placebo-blinded proof-of-concept trial
Capsaicin 8 patches trans-cinnamaldehyde 10 L-menthol 40 and inert vehicle patches will each be applied to 4 4x4 cm predefined areas on the skin of the volar forearms for 1 hour 4 times on 4 consecutive days Before each application and the day after the last application cold detection threshold CDT warmth detection threshold WDT cold pain threshold CPT and heat pain threshold HPT will be assessed using a Medoc Pathway Medoc Israel equipped with a 3x3 cm contact thermode On the last day mechanical detection threshold MDT is assessed using a series of von Frey filaments and mechanical pain threshold MPT and mechanical pain sensitivity MPS is assessed using a series of standardized pinprick stimulators Aalborg University
Furthermore full-field laser perfusion imaging FLPI will be used to assess the degree of neurogenic inflammation in each predefined area before and after each substance application and at the last session
1 F Henrich et al 2015 Capsaicin-sensitive C- and A-fibre nociceptors control long-term potentiation-like pain amplification in humans
2 HH Andersen et al 2017 Antipruritic effect of pretreatment with 8 topical capsaicin on histamine- and cowhage-evoked itch in healthy volunteers - a randomized placebo-blinded proof-of-concept trial
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?:
None
Is an FDA AA801 Violation?:
None