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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 August 2015 |
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Main ID: |
NCT02533076 |
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Date of registration:
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14/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Functional Consequences of the CTNS-deletion for the TRPV1-receptor in Cystinosis Patients
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Scientific title:
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The Functional Consequences of the CTNS-deletion for the TRPV1-receptor in Cystinosis Patients |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02533076 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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Phase 0
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Countries of recruitment
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Belgium
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Only healthy controls: Subject is in good health, based on medical history and
physical examination
- White (Caucasian) male or female subjects, aged > or = 8 year.
- Subject is capable and willing to give informed consent.
Exclusion Criteria:
- Any abnormality of the skin which may interfere with the study assessments.
- Excessive hair growth on the volar surface of the forearm.
- Excessive tanning (any exposure to sunlight or a tanning bed which would cause a
sunburn reaction) throughout the study and incapable to cover the forearms for 24
hours prior to the study period.
- Subject using topical treatments on the forearm.
- History of sensitivity to the fruits of capsicum plants (e.g. chilli peppers).
- Any situation that can compromise the study, including a predictable lack of
cooperation from the volunteer.
- Female subject is pregnant or breastfeeding.
Age minimum:
8 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystinosis
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Intervention(s)
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Device: Temperature sensitivity measurement with Advanced Thermal Stimulation
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Other: Challenge agent: placebo
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Other: Challenge agent: capsaicin
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Device: Mechanical stimulation with Von Frey filaments
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Primary Outcome(s)
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Change from baseline of the dermal blood flow response to topical applied capsaicin at 10, 20, 30, 40, 50 and 60 minutes, measured with Laser Doppler Imaging and expressed in % change to baseline
[Time Frame: Day 1 at baseline and 10, 20, 30, 40, 50 and 60 minutes after capsaicin application]
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Secondary Outcome(s)
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Change from baseline of the skin sensitivity response after topical applied capsaicin at 10, 20, 30, 40, 50 and 60 minutes, measured with the Numerical rating scale and skin sensitivity to mechanical stimulation, measured with Von Frey filaments.
[Time Frame: Day 1 at baseline and 10, 20, 30, 40, 50 and 60 minutes after capsaicin application]
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Temperature sensitivity (detection and pain threshold), measured with Advanced Thermal stimulation and expressed in degrees Celsius.
[Time Frame: Day 1]
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Secondary ID(s)
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CCP13-3302-CYST
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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