The Role of TRP Channels in DPN (NCT07237022) | Clinical Trial Compass
RecruitingNot Applicable
The Role of TRP Channels in DPN
Belgium20 participantsStarted 2025-10-08
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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
✓. Subject understands the procedures and agrees to participate in the study by giving written informed consent.
Exclusion criteria
✕. 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
✕. Subject currently uses lotions, oils, depilatory preparations, makeup, or other topical treatments on the feet on a regular basis which cannot be discontinued for the duration of the study
✕. Subject has eczema, scleroderma, psoriasis, dermatitis or keloids, tumors, ulcers, burns, skin flaps or grafts on the volar surface of the forearm or the dorsum of the feet, or any other skin abnormality that, in the opinion of the investigator, may interfere with the study assessments
What they're measuring
1
Dermal Blood Flow response (PU)
Timeframe: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.
2
Flare area (mm²)
Timeframe: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.
✕. Subject has excessive hair growth on the volar surface of the forearms or the dorsum of the feet
✕. Subject has any of the following vital sign measurements at screening after at least 10 minutes of supine rest: Heart Rate \<40 or \>100 beats/min, Diastolic Blood Pressure \<50 or \>90 mmHg, Systolic Blood Pressure \<90 or \>140 mmHg