PainNCT03132142
Desensitization of Nociceptive Afferents by Application of Topical Capsaicin, Trans-cinnamaldehyde and L-menthol
A study testing Capsaicin, Trans-cinnamaldehyde and L-Menthol in people with Pain and Pruritus, run by Aalborg University at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the potential desensitising effects of repeated applications of capsaicin, trans-cinnamaldehyde and L-menthol on thermal, mechanical and chemical sensory stimulations. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Pruritus, Neuropathic Pain
- What is being tested?
- Capsaicin, Trans-cinnamaldehyde and L-Menthol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2017to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Speaks and understands English or Danish
- 18-60 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
SMI
Aalborg, 9000
Hjalte H Andersen, MSc. Med., 0045 24464515, hha@hst.aau.dk
Jens B Marker, BSc. Med.
About this study
Official title: 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
The purpose of this study is to investigate the potential desensitising effects of repeated applications of capsaicin, trans-cinnamaldehyde and L-menthol on thermal, mechanical and chemical sensory stimulations.
Read the 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"
- Conditions
- Pain, Pruritus, Neuropathic Pain, Dermatology/Skin - Other
- Being tested
- Capsaicin, Trans-cinnamaldehyde, L-Menthol, Vehicle patch
- Medical subject headings
- Pain, Pruritus, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
4x4 cm patch of 8% topical capsaicin applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
Trans-cinnamaldehydeDrug
1mL of 10% trans-cinnamaldehyde applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
L-MentholDrug
1mL of 40% L-menthol applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
Vehicle patchDrug
Inert vehicle patch applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin | Experimental | Capsacin (8%) patches applied topically 4 times for 1 hour to a 4x4 cm predefined area on the skin of the volar forearms. Receives: Drug: Capsaicin |
| Trans-cinnamaldehyde | Experimental | 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. Receives: Drug: Trans-cinnamaldehyde |
| L-menthol | Experimental | 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. Receives: Drug: L-Menthol |
| Vehicle patch | Placebo comparator | Inert vehicle patches applied topically 4 times for 1 hour to a 4x4 cm predefined area on the skin of the volar forearms. Receives: Drug: Vehicle patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold Pain Threshold (CPT)
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.
Measured: Assessed at 5 visits on 5 consecutive days
Heat Pain Threshold (HPT)
The pain threshold for heat stimulation
Measured: Assessed at 5 visits on 5 consecutive days
Secondary outcomes (12)
Neurogenic Inflammation Intensity
The average intensity of the neurogenic inflammation as assessed by full-field laser perfusion imaging (FLPI) (expressed in arbitrary units)
Measured: Assessed before and after application of substances at 5 visits on 5 consecutive days
Neurogenic Inflammation Area
The area of the neurogenic inflammation as assessed by full-field laser perfusion imaging (FLPI) (expressed in arbitrary units)
Measured: Assessed before and after application of substances at 5 visits on 5 consecutive days
Pain During Application of Capsaicin
Pain during the 60 minute application of topical capsaicin as rated on a visual analog scale (VAS) (0-10)
Measured: Assessed every 5 minutes during the 60 minute application of capsaicin at 4 visits on 4 consecutive days
Pain During Application of Trans-cinnamaldehyde
Pain during the 60 minute application of trans-cinnamaldehyde as rated on a visual analog scale (VAS) (0-10)
Measured: 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
Pain during the 60 minute application of L-menthol as rated on a visual analog scale (VAS) (0-10)
Measured: Assessed every 5 minutes during the 60 minute application of L-menthol at 4 visits on 4 consecutive days
Pain During Application of Inert Patch (Control)
Pain during the 60 minute application of the inert patch (control) as rated on a visual analog scale (VAS) (0-10)
Measured: 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)
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.
Measured: Assessed at 5 visits on 5 consecutive days
Warmth Detection Threshold (WDT)
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.
Measured: Assessed at 5 visits on 5 consecutive days
Mechanical Detection Threshold (MDT)
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.
Measured: Assessed at day 5 (final visit)
Mechanical Pain Threshold (MPT)
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.
Measured: Assessed at day 5 (final visit)
Mechanical Pain Sensitivity (MPS)
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.
Measured: Assessed at day 5 (final visit)
Vibration Detection Threshold
The detection threshold for vibrational stimulation assessed using a Vibrameter (Somedic, Sweden).
Measured: Assessed at day 5 (final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study startApr 2017 (estimated)
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hjalte Holm Andersen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132142
- Sponsor's protocol ID
- N-20170018
- Status last verified
- Apr 2017
- First submitted
- 25 Apr 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03132142
- Acronym / sponsor ID
- N-20170018
- Conditions
- Pain, Pruritus, Neuropathic Pain, Dermatology/Skin - Other
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- Apr 2017 (estimated)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the potential desensitising effects of repeated applications of capsaicin, trans-cinnamaldehyde and L-menthol on thermal, mechanical and chemical sensory stimulations.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Capsaicin | Experimental | Drug: CapsaicinCapsacin (8%) patches applied topically 4 times for 1 hour to a 4x4 cm predefined area on the skin of the volar forearms. |
| Trans-cinnamaldehyde | Experimental | Drug: Trans-cinnamaldehydeTrans-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. |
| L-menthol | Experimental | Drug: L-MentholL-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. |
| Vehicle patch | Placebo comparator | Drug: Vehicle patchInert vehicle patches applied topically 4 times for 1 hour to a 4x4 cm predefined area on the skin of the volar forearms. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Speaks and understands English or Danish
- 18-60 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin4x4 cm patch of 8% topical capsaicin applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days | Drug | Capsaicin |
| Trans-cinnamaldehyde1mL of 10% trans-cinnamaldehyde applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days | Drug | Trans-cinnamaldehyde |
| L-Menthol1mL of 40% L-menthol applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days | Drug | L-menthol |
| Vehicle patchInert vehicle patch applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days | Drug | Vehicle patch |
Primary outcome
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.
Heat Pain Threshold (HPT)
Time frame: Assessed at 5 visits on 5 consecutive days
The pain threshold for heat stimulation
12 secondary outcomes
Neurogenic Inflammation Intensity
Time frame: 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
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 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
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
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
Cold Detection Threshold (CDT)
Time frame: Assessed at 5 visits on 5 consecutive days
Warmth Detection Threshold (WDT)
Time frame: Assessed at 5 visits on 5 consecutive days
Mechanical Detection Threshold (MDT)
Time frame: Assessed at day 5 (final visit)
Mechanical Pain Threshold (MPT)
Time frame: Assessed at day 5 (final visit)
Mechanical Pain Sensitivity (MPS)
Time frame: Assessed at day 5 (final visit)
Vibration Detection Threshold
Time frame: Assessed at day 5 (final visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsaicin, Trans-cinnamaldehyde and L-Menthol in people with Pain and Pruritus, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Arendt-Nielsen, Professor (0045 99408830, lan@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cold Pain Threshold (CPT) (time frame: Assessed at 5 visits on 5 consecutive days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.