Recruiting NCT07237022
The Role of TRP Channels in DPN
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cinnamaldehyde, Allyl isothiocyanate (AITC), Capsaicin.
- Who it may be relevant to
- Registry conditions: Physiological Responses. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of Transient Receptor Potential Channels in Diabetic Peripheral Neuropathy
Overview
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.
Interventions
- Other Cinnamaldehyde
A 10% and 30% cinnamaldehyde solution is topically applied on foot skin. - Other Allyl isothiocyanate (AITC)
A 15% and up to 30% AITC solution is topically applied on foot skin. - Other Capsaicin
A 1.5% and 5% capsaicin solution is topically applied on foot skin.
Primary outcome measures
- Dermal Blood Flow response (PU) [Time frame: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.]
- Flare area (mm²) [Time frame: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.]
Secondary outcome measures (1)
- Numeric Rating Scale (NRS) pain score [Time frame: Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application.]
Eligibility criteria
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
- 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
- Subject is unable to refrain from drinking caffeinated beverages (e.g. coffee, tea, cola, …) 24 hours prior to each study visit. Subject is unable to limit their intake of caffeinated beverages to ≤4 cups a day throughout the study
- Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a regular user of illegal drugs, or has a history of substance abuse (including alcohol)
- Subject is currently participating or has been involved in testing an investigational drug in another clinical study within the last 4 weeks
- Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with safe and optimal participation in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Center for Clinical Pharmacology — Leuven
Identifiers
NCT: NCT07237022 · CCP24-3303-DPN