Small fibre neuropathy
Conditions
Interventions
- 8% Capsaicin patch (Qutenza)
- 0.075% Capsaïcine crème FNA [Formularium der Nederlandse Apothekers]
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Agree to and be capable of signing an informed consent form. - Healthy male and female subjects; - Age: 18 to 65 years at screening (inclusive); - Body mass index between 18-30 kg*m-2 (inclusive); - Able to refrain from strenuous physical exercise from 48 hours prior to admission and during each stay at the CHDR clinic; - Able to refrain from use of all (methyl)xanthenes (e.g. coffee, tea, cola, chocolate) from 12 hours prior to admission and during each stay at the CHDR clinic; - Able to refrain from alcohol use from 24 hours prior to admission and during each stay at the CHDR clinic; - Ability to communicate well with the investigator in the Dutch language; and - Ability for female subjects to attend study day 0 while in the follicular phase (3-13 days after onset of menstruation).
Exclusion criteria
Exclusion criteria: - Legal incapacity or inability to understand or comply with the requirements of the study; - Clinically significant findings as determined by medical history taking, physical examination, ECG and vital signs; - Hemodynamic status at screening: systolic <100 and >160 mmHg, diastolic <50 and >95 mmHg, heart rate <45 and >100 bpm measured on the non-dominant (non-leading/non-writing hand) arm; - Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism), pain (disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy, etc.) or capsaicin (eczema, etc); - Pregnancy; - Dark skin (Fitzpatrick skin type V or VI), wide-spread acne, tattoos or scarring on back or upper leg; - Subjects indicating nociceptive tests (including capsaicin formulation) intolerable or insensitive at screening; - Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or a positive alcohol breath test at screening; - Consume, on average, >8 units/day of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) and not able to refrain from use during each stay at the CHDR clinic; - History or clinical evidence of alcoholism or drug abuse; - Smoking of >5 cigarettes/day or equivalent and not able to abstain from smoking cigarettes during each stay at the CHDR clinic; - Use of prescription, illicit or herbal drugs within 7 days of nociceptive assessments; - Use of over-the-counter medications within 3 days of nociceptive assessments; and/or - Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline demographics & personality Immunogenicity Pharmacodynamics Leg -Intra-epidermal nerve fibre density [IENFD] -Quantitative sensory testing [QST] (Leg PD) -Videothermography [VT] (Leg PD) -Laser Doppler blood flow [LDBF] Pharmacodynamics Back -Heat-Capsaicin-Warmth Model (Back PD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics PainCart - Nociceptive Pain Tasks Potential for pain an discomfort associated with skin biopsies, pain tests and capsaicin applications. No benefit to the individual is expected. | — |
Countries
Netherlands
Outcome results
None listed