The Role of TRP Channels in DPN
ConditionPhysiological Responses
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
The study aims to characterize the vascular response upon topical application of cinnamaldehyde, allyl isothiocyanate and capsaicin on feet skin in healthy volunteers. The vascular response will be characterized in terms of response over time, dose-response, inter-foot and inter-period reproducibility.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject is a white male or female ≥18 and ≤45 years of age
Subject is a non-smoker for at least 6 months prior to the start of the study
Subject has a body mass index (BMI) between 18-30 kg/m²
Subject is judged to be in good general health on the basis of medical history, physical examination and vital signs
Disqualifiers
Subject has a history of any illness or disorder which, in the investigator's opinion, might confound the results of the study
Subject has a history of significant severe (drug) allergies
Subject is a female who is pregnant, breast-feeding or intends to become pregnant, or is of child-bearing potential and is not using an adequate contraceptive method
Subject uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study
Trial population
Healthy male and female volunteers aged 18 to 45 years (inclusive)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cinnamaldehyde
Other interventionA 10% and 30% cinnamaldehyde solution is topically applied on foot skin.
Allyl isothiocyanate (AITC)
Other interventionA 15% and up to 30% AITC solution is topically applied on foot skin.
Capsaicin
Other interventionA 1.5% and 5% capsaicin solution is topically applied on foot skin.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Dermal Blood Flow response (PU)
The DBF response prior to and at each point in time after topical application of cinnamaldehyde, AITC and capsaicin on the foot, assessed with LSCI, within the area of application, expressed in arbitrary perfusion units (PU).
Time frame
Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.2
Flare area (mm²)
The flare area of the DBF response prior to and at each point in time after topical application of cinnamaldehyde, AITC and capsaicin on the feet, assessed with LSCI.
Time frame
Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.Secondary outcomes
1
Numeric Rating Scale (NRS) pain score
The Numeric Rating Scale (NRS)-11 pain score at each point in time after topical application of cinnamaldehyde, AITC and capsaicin on the feet.
Time frame
Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov