CapsaicinNCT03587220
A Mechanistic Evaluation of the Nociceptive Desensitizing Properties of Topical Capsaicin
A study testing Capsaicin Topical, Ultraviolet-B (UVB) irradiation and Histamine 1% in people with Capsaicin and Ultaviolet B Light Burn, run by Aalborg University at 1 site in Denmark.
Trial summary
The aim of this project is to study the role of transient receptor potential (TRP-) channel V1 (TRPV1+) fibers in the development of cutaneous inflammation induced by epidermal Ultraviolet-B damage. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Capsaicin, Ultaviolet B Light Burn, Neuropathic Pain
- What is being tested?
- Capsaicin Topical, Ultraviolet-B (UVB) irradiation and Histamine 1%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2018to 31 Dec 2019
- 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 men and women
- 18-60 years
- Caucasian descent (only in sub-study 1)
- Speak and understand English
Who cannot join
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids or other drugs
- Previous or current neurologic, musculoskeletal or mental illnesses
- Lack of ability to cooperate
- Current use of medications that may affect the trial
- Skin diseases
Show all 12Show fewer
- Consumption of alcohol or painkillers 24 hours before the study days and between these
- Moles or tattoos in the area to be treated or tested.
- Exposure of the irradiated area to UV radiation (e.g., sun) 48 hours before the study days and between these
- Acute or chronic pain
- Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
- Known history of anaphylactic shock, or local allergy (contact dermatitis) to lidocaine, prilocaine or other local anaesthetics of the amide type.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: En undersøgelse af Mekanismerne Bag Nociceptiv Desensibilisering forårsaget af Topikal Capsaicin
The aim of this project is to study the role of transient receptor potential (TRP-) channel V1 (TRPV1+) fibers in the development of cutaneous inflammation induced by epidermal Ultraviolet-B damage. Moreover, in this project the investigators want to evaluate if the capsaicin-desensitization action can still be induced in a skin area pretreated with topical, local anesthetic lidocaine.
Read the detailed description
In this project the Ultraviolet- B pain model, a model using type B ultraviolet rays to induce a first-degree sunburn, will be used to induce a non-specific inflammation in the skin. This model is well-known to produce both peripheral and central hyperalgesia through sensitization of peripheral and central nociceptors. Capsaicin, the active substance in chili peppers, is currently used to treat peripheral neuropathic pain, and prolonged application of 8% capsaicin patch causes profound desensitization to painful heat stimuli and itch provocations. Therefore, the investigators would like to monitor the development of unspecific UVB-cutaneous inflammation and consequent neurogenic flare in a capsaicin pre-treated area. Moreover the investigators want to test if pre-treating the skin with lidocaine can reduce the pain associated with the capsaicin application without affecting its desensitization action.
- Conditions
- Capsaicin, Ultaviolet B Light Burn, Neuropathic Pain, Lidocaine
- Being tested
- Capsaicin Topical, Ultraviolet-B (UVB) irradiation, Histamine 1%, Lidocaine
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin TopicalDrug
Capsaicin patches (dosage form: patch 8% Qutenza) will be applied on 4x4 cm squared areas on the volar forearm. The patches will be left in place for 24h and 3 hours after which they will be removed.
Ultraviolet-B (UVB) irradiationRadiation
Two circular areas (Ø 2 cm) on the forearm are irradiated with 2 x MED (Minimal Erythema Dose) dose of UVB using a calibrated UVB machine (290-320nm wavelength), Saal Mann Multi Tester (Mann Saal, LT SBC 400 Herford, Germany).
Histamine 1%Other
To deliver histamine, standard allergy skin prick test (SPT) lancets are applied. The lancets have a 1 mm shouldered tip adapt to introduce a small amount of test substance extremely locally and approximately at the dermo-epidermal junction.
LidocaineDrug
Cutaneous anaesthesia will be topically induced by using EMLA cream 5%, a local anaesthetic cream consisting of equal parts of lidocaine and prilocaine (1g contains 25 mg of lidocaine and 25 mg of prilocaine)
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin+UVB group | Experimental | All subjects will be treated with capsaicin, placebo + UVB, or Capsaicin+UVB. Receives: Drug: Capsaicin Topical; Radiation: Ultraviolet-B (UVB) irradiation |
| Capsaicin + EMLA group | Experimental | All subjects will be pre-treated with lidocain cream before capsaicin application Receives: Drug: Capsaicin Topical; Other: Histamine 1%; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superficial blood perfusion measured by a Speckle contrast imager (FLPI, Moor Instruments, England).
Measured: Changes from baseline to 7 days after intervention
Measurement of Warm Detection Thresholds and Heat thresholds by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Measured: Changes from baseline to 7 days after intervention
Measurement of Pain to Supra-threshold Heat Stimuli by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Measured: Changes from baseline to 7 days after intervention
Measurement of Mechanical Pain Thresholds and Sensitivity using a pin-prick set consisting of 8 needles each having a diameter of 0.6 mm and different force applications: 0.8, 1.6, 3.2, 6.4, 12.8, 25.6, 50.1 and 60.0 g.
Measured: Changes from baseline to 7 days after intervention
Trans-epidermal Water Loss (TEWL) using a 2x2 cm probe to measure the humidity gradient of the skin.
Measured: Changes from baseline to 7 days after intervention
Secondary outcomes (2)
assessment of pain rating by using a visual analog scales (VAS)
The subject will report the peak and average of the perceived pain sensation during the last 24 hours (on a VAs scale from 0 indicating 'no pain' to100 indicating 'worst imaginable pain').
Measured: Change from baseline to 24 h
Itch rating by using a visual analog scales (VAS)
Itch is monitored for 9 minutes using a visual analog scale from 0 indicating 'no itch' to100 indicating 'worst imaginable itch.
Measured: Changes from baseline to 7 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start1 Aug 2018
- Primary completion31 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CapsaicinStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Lo Vecchio, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587220
- Sponsor's protocol ID
- N-20180034
- Status last verified
- Apr 2020
- First submitted
- 21 Jun 2018
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- En undersøgelse af Mekanismerne Bag Nociceptiv Desensibilisering forårsaget af Topikal Capsaicin
- ClinicalTrials.gov ID
- NCT03587220
- Acronym / sponsor ID
- N-20180034
- Conditions
- Capsaicin, Ultaviolet B Light Burn, Neuropathic Pain, Lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Jul 2018 (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 aim of this project is to study the role of transient receptor potential (TRP-) channel V1 (TRPV1+) fibers in the development of cutaneous inflammation induced by epidermal Ultraviolet-B damage. Moreover, in this project the investigators want to evaluate if the capsaicin-desensitization action can still be induced in a skin area pretreated with topical, local anesthetic lidocaine.
Detailed description
In this project the Ultraviolet- B pain model, a model using type B ultraviolet rays to induce a first-degree sunburn, will be used to induce a non-specific inflammation in the skin. This model is well-known to produce both peripheral and central hyperalgesia through sensitization of peripheral and central nociceptors. Capsaicin, the active substance in chili peppers, is currently used to treat peripheral neuropathic pain, and prolonged application of 8% capsaicin patch causes profound desensitization to painful heat stimuli and itch provocations. Therefore, the investigators would like to monitor the development of unspecific UVB-cutaneous inflammation and consequent neurogenic flare in a capsaicin pre-treated area. Moreover the investigators want to test if pre-treating the skin with lidocaine can reduce the pain associated with the capsaicin application without affecting its desensitization action.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin+UVB group | Experimental | Drug: Capsaicin Topical, Radiation: Ultraviolet-B (UVB) irradiationAll subjects will be treated with capsaicin, placebo + UVB, or Capsaicin+UVB. |
| Capsaicin + EMLA group | Experimental | Drug: Capsaicin Topical, Other: Histamine 1%, Drug: LidocaineAll subjects will be pre-treated with lidocain cream before capsaicin application |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women
- 18-60 years
- Caucasian descent (only in sub-study 1)
- Speak and understand English
Key exclusion criteria (12 listed)
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids or other drugs
- Previous or current neurologic, 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 |
|---|---|---|
| Capsaicin TopicalCapsaicin patches (dosage form: patch 8% Qutenza) will be applied on 4x4 cm squared areas on the volar forearm. The patches will be left in place for 24h and 3 hours after which they will be removed. | Drug | Capsaicin + EMLA group, Capsaicin+UVB group |
| Ultraviolet-B (UVB) irradiationTwo circular areas (Ø 2 cm) on the forearm are irradiated with 2 x MED (Minimal Erythema Dose) dose of UVB using a calibrated UVB machine (290-320nm wavelength), Saal Mann Multi Tester (Mann Saal, LT SBC 400 Herford, Germany). | Radiation | Capsaicin+UVB group |
| Histamine 1%To deliver histamine, standard allergy skin prick test (SPT) lancets are applied. The lancets have a 1 mm shouldered tip adapt to introduce a small amount of test substance extremely locally and approximately at the dermo-epidermal junction. | Other | Capsaicin + EMLA group |
| LidocaineCutaneous anaesthesia will be topically induced by using EMLA cream 5%, a local anaesthetic cream consisting of equal parts of lidocaine and prilocaine (1g contains 25 mg of lidocaine and 25 mg of prilocaine) | Drug | Capsaicin + EMLA group |
Primary outcome
Superficial blood perfusion measured by a Speckle contrast imager (FLPI, Moor Instruments, England).
Time frame: Changes from baseline to 7 days after intervention
Measurement of Warm Detection Thresholds and Heat thresholds by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Time frame: Changes from baseline to 7 days after intervention
Measurement of Pain to Supra-threshold Heat Stimuli by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Time frame: Changes from baseline to 7 days after intervention
Measurement of Mechanical Pain Thresholds and Sensitivity using a pin-prick set consisting of 8 needles each having a diameter of 0.6 mm and different force applications: 0.8, 1.6, 3.2, 6.4, 12.8, 25.6, 50.1 and 60.0 g.
Time frame: Changes from baseline to 7 days after intervention
Trans-epidermal Water Loss (TEWL) using a 2x2 cm probe to measure the humidity gradient of the skin.
Time frame: Changes from baseline to 7 days after intervention
2 secondary outcomes
assessment of pain rating by using a visual analog scales (VAS)
Time frame: Change from baseline to 24 h
Itch rating by using a visual analog scales (VAS)
Time frame: Changes from baseline to 7 days after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Topical, Ultraviolet-B (UVB) irradiation and Histamine 1% in people with Capsaicin and Ultaviolet B Light Burn, 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 20 Apr 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superficial blood perfusion measured by a Speckle contrast imager (FLPI, Moor Instruments, England). (time frame: Changes from baseline to 7 days after intervention). The study lists 5 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 20 Apr 2020.