- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03132142
Desensitization of Nociceptive Afferents by Application of Topical Capsaicin, Trans-cinnamaldehyde and L-menthol
Temporal Profile of the Nociceptive Desensitization Induced by 8% Topical Capsaicin and the Functional Independence of Transient Receptor Potential Ankyrin 1 (TPRA1)- and Vanilloid 1 (TRPV1)-Expressing Nociceptive Afferents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Capsaicin, the compound responsible for the pungency of chili peppers, can induce desensitization to nociceptive (1) and pruriceptive (2) stimuli when topically applied. The purpose of this study is to determine whether repeated topical applications of trans-cinnamaldehyde and L-menthol result in decreased responses to various nociceptive and non-nociceptive thermal and mechanical stimuli and to compare potential alterations with those caused by repeated topical application of capsaicin. Furthermore, this study investigates the temporal profile of said alterations.
Capsaicin 8% patches, trans-cinnamaldehyde 10%, L-menthol 40% and inert vehicle patches will each be applied to 4 4x4 cm predefined areas on the skin of the volar forearms for 1 hour 4 times on 4 consecutive days. Before each application and the day after the last application, cold detection threshold (CDT), warmth detection threshold (WDT), cold pain threshold (CPT) and heat pain threshold (HPT) will be assessed using a Medoc Pathway (Medoc, Israel) equipped with a 3x3 cm contact thermode. On the last day, mechanical detection threshold (MDT) is assessed using a series of von Frey filaments and mechanical pain threshold (MPT) and mechanical pain sensitivity (MPS) is assessed using a series of standardized pinprick stimulators (Aalborg University).
Furthermore, full-field laser perfusion imaging (FLPI) will be used to assess the degree of neurogenic inflammation in each predefined area before and after each substance application and at the last session.
- F. Henrich et al. 2015 "Capsaicin-sensitive C- and A-fibre nociceptors control long-term potentiation-like pain amplification in humans"
- H.H. Andersen et al. 2017 "Antipruritic effect of pretreatment with 8% topical capsaicin on histamine- and cowhage-evoked itch in healthy volunteers - a randomized placebo-blinded proof-of-concept trial"
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lars Arendt-Nielsen, Professor
- Phone Number: 0045 99408830
- Email: lan@hst.aau.dk
Study Locations
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-
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Aalborg, Denmark, 9000
- Recruiting
- SMI
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Contact:
- Hjalte H Andersen, MSc. Med.
- Phone Number: 0045 24464515
- Email: hha@hst.aau.dk
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Sub-Investigator:
- Jens B Marker, BSc. Med.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy
- Speaks and understands English or Danish
- 18-60 years
Exclusion Criteria:
- Pregnancy or lactation
- Drug addiction
- Previous or current dermatological, neurological, musculoskeletal or mental illnesses
- Lack of ability to cooperate
- Current use of medications that may affect the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Capsaicin
Capsacin (8%) patches applied topically 4 times for 1 hour to a 4x4 cm predefined area on the skin of the volar forearms.
|
4x4 cm patch of 8% topical capsaicin applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
|
Experimental: Trans-cinnamaldehyde
Trans-cinnamaldehyde (10%, dissolved in 90% ethanol) applied topically 4 times for 1 hour to a 4x4 cm predefined area on the skin of the volar forearms on a cotton ball placed in a plastic chamber to limit evaporation.
|
1mL of 10% trans-cinnamaldehyde applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
|
Experimental: L-menthol
L-menthol (40%, dissolved in 96% ethanol) applied topically 4 times for 1 hour to a 4x4 cm predefined area on the skin of the volar forearms on a cotton ball placed in a plastic chamber to limit evaporation.
|
1mL of 40% L-menthol applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
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Placebo Comparator: Vehicle patch
Inert vehicle patches applied topically 4 times for 1 hour to a 4x4 cm predefined area on the skin of the volar forearms.
|
Inert vehicle patch applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cold Pain Threshold (CPT)
Time Frame: Assessed at 5 visits on 5 consecutive days
|
The pain threshold for cold stimulation assessed using a Medoc Pathway (Medoc, Israel) equipped with a 3x3 cm thermode.
CPT is defined as the temperature at which cold induces pain and is expressed in °C.
|
Assessed at 5 visits on 5 consecutive days
|
Heat Pain Threshold (HPT)
Time Frame: Assessed at 5 visits on 5 consecutive days
|
The pain threshold for heat stimulation
|
Assessed at 5 visits on 5 consecutive days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurogenic Inflammation Intensity
Time Frame: Assessed before and after application of substances at 5 visits on 5 consecutive days
|
The average intensity of the neurogenic inflammation as assessed by full-field laser perfusion imaging (FLPI) (expressed in arbitrary units)
|
Assessed before and after application of substances at 5 visits on 5 consecutive days
|
Neurogenic Inflammation Area
Time Frame: Assessed before and after application of substances at 5 visits on 5 consecutive days
|
The area of the neurogenic inflammation as assessed by full-field laser perfusion imaging (FLPI) (expressed in arbitrary units)
|
Assessed before and after application of substances at 5 visits on 5 consecutive days
|
Pain During Application of Capsaicin
Time Frame: Assessed every 5 minutes during the 60 minute application of capsaicin at 4 visits on 4 consecutive days
|
Pain during the 60 minute application of topical capsaicin as rated on a visual analog scale (VAS) (0-10)
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Assessed every 5 minutes during the 60 minute application of capsaicin at 4 visits on 4 consecutive days
|
Pain During Application of Trans-cinnamaldehyde
Time Frame: Assessed every 5 minutes during the 60 minute application of trans-cinnamaldehyde at 4 visits on 4 consecutive days
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Pain during the 60 minute application of trans-cinnamaldehyde as rated on a visual analog scale (VAS) (0-10)
|
Assessed every 5 minutes during the 60 minute application of trans-cinnamaldehyde at 4 visits on 4 consecutive days
|
Pain During Application of L-menthol
Time Frame: Assessed every 5 minutes during the 60 minute application of L-menthol at 4 visits on 4 consecutive days
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Pain during the 60 minute application of L-menthol as rated on a visual analog scale (VAS) (0-10)
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Assessed every 5 minutes during the 60 minute application of L-menthol at 4 visits on 4 consecutive days
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Pain During Application of Inert Patch (Control)
Time Frame: Assessed every 5 minutes during the 60 minute application of the inert patch (control) at 4 visits on 4 consecutive days
|
Pain during the 60 minute application of the inert patch (control) as rated on a visual analog scale (VAS) (0-10)
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Assessed every 5 minutes during the 60 minute application of the inert patch (control) at 4 visits on 4 consecutive days
|
Cold Detection Threshold (CDT)
Time Frame: Assessed at 5 visits on 5 consecutive days
|
The detection threshold for cold stimulation assessed using a Medoc Pathway (Medoc, Israel) equipped with a 3x3 cm thermode.
CDT is defined as the temperature at which cold can be detected and is expressed in °C.
|
Assessed at 5 visits on 5 consecutive days
|
Warmth Detection Threshold (WDT)
Time Frame: Assessed at 5 visits on 5 consecutive days
|
The detection threshold for warmth stimulation assessed using a Medoc Pathway (Medoc, Israel) equipped with a 3x3 cm thermode.
WDT is defined as the temperature at which warmth can be detected and is expressed in °C.
|
Assessed at 5 visits on 5 consecutive days
|
Mechanical Detection Threshold (MDT)
Time Frame: Assessed at day 5 (final visit)
|
The detection threshold for mechanical stimulation is defined as the smallest force that can be felt and is assessed using a series of standardized von Frey filaments and using the "method of limits" employing a series of stimulations with ascending and descending force expressed in mN.
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Assessed at day 5 (final visit)
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Mechanical Pain Threshold (MPT)
Time Frame: Assessed at day 5 (final visit)
|
The pain threshold for mechanical stimulation is defined as the smallest force that induces pain and is assessed using a series of standardized pinprick stimulators (Aalborg University) and using the "method of limits" employing a series of stimulations with ascending and descending forces expressed in mN.
|
Assessed at day 5 (final visit)
|
Mechanical Pain Sensitivity (MPS)
Time Frame: Assessed at day 5 (final visit)
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The sensitivity to mechanically induced pain induced by a series of 7 standardized pinprick stimulators (Aalborg University) as rated on a visual analog scale (VAS) ranging from 0-10 with 0 representing no pain and 10 representing the worst pain imaginable.
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Assessed at day 5 (final visit)
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Vibration Detection Threshold
Time Frame: Assessed at day 5 (final visit)
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The detection threshold for vibrational stimulation assessed using a Vibrameter (Somedic, Sweden).
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Assessed at day 5 (final visit)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Skin Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Skin Manifestations
- Neuralgia
- Pruritus
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Antineoplastic Agents
- Protective Agents
- Antineoplastic Agents, Phytogenic
- Dermatologic Agents
- Antipruritics
- Antimutagenic Agents
- Capsaicin
- Menthol
- Cinnamaldehyde
Other Study ID Numbers
- N-20170018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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