L-menthol as a Topical Counter-irritant to TRPA1-induced Neurogenic Inflammation and Pain

NCT ID: NCT02653703

Last Updated: 2016-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-12-31

Brief Summary

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The aim of this study is to quantitatively characterize the effects of L-menthol as a topical counter-irritant on cutaneous pain and hyperalgesia provoked by topical application of the TRPA1-agonist trans-cinnamaldehyde (CA) in healthy human volunteers.

Detailed Description

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This study is designed as an experimental model in healthy humans.

Conditions

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Inflammation Pruritus Hyperalgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vehicle, topical ethanol 96%

Exposure: 10 % topical trans-cinnamaldehyde \[CAS Number: 14371-10-9\] Vehicle: 96% ethanol

Group Type PLACEBO_COMPARATOR

Vehicle, topical ethanol 96%

Intervention Type OTHER

Organic solvent CAS Number: 64-17-5

Topical L-menthol 40%

Exposure: 10 % trans-cinnamaldehyde \[CAS Number: 14371-10-9\] Intervention: 40% l-menthol \[CAS Number: 2216-51-5\] Vehicle: 96% ethanol

Group Type EXPERIMENTAL

Topical L-menthol 40%

Intervention Type OTHER

Naturally occurring local anaesthetic, counterirritant and TPRM8-agonist. CAS Number: 2216-51-5

Interventions

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Topical L-menthol 40%

Naturally occurring local anaesthetic, counterirritant and TPRM8-agonist. CAS Number: 2216-51-5

Intervention Type OTHER

Vehicle, topical ethanol 96%

Organic solvent CAS Number: 64-17-5

Intervention Type OTHER

Other Intervention Names

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Menthol

Eligibility Criteria

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Inclusion Criteria

* 18 healthy men and women aged 18-50 years willing to abstain from alcohol, nicotine, caffeine and pain medication 24 hours before experimental sessions

Exclusion Criteria

* Pregnancy
* Skin disorders (e.g. contact eczema)
* Chronic pain conditions
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Parisa Gazerani

Professor, PharmD, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Olsen RV, Andersen HH, Moller HG, Eskelund PW, Arendt-Nielsen L. Somatosensory and vasomotor manifestations of individual and combined stimulation of TRPM8 and TRPA1 using topical L-menthol and trans-cinnamaldehyde in healthy volunteers. Eur J Pain. 2014 Oct;18(9):1333-42. doi: 10.1002/j.1532-2149.2014.494.x. Epub 2014 Mar 25.

Reference Type BACKGROUND
PMID: 24664788 (View on PubMed)

Hojland CR, Andersen HH, Poulsen JN, Arendt-Nielsen L, Gazerani P. A human surrogate model of itch utilizing the TRPA1 agonist trans-cinnamaldehyde. Acta Derm Venereol. 2015 Sep;95(7):798-803. doi: 10.2340/00015555-2103.

Reference Type BACKGROUND
PMID: 25792226 (View on PubMed)

Namer B, Seifert F, Handwerker HO, Maihofner C. TRPA1 and TRPM8 activation in humans: effects of cinnamaldehyde and menthol. Neuroreport. 2005 Jun 21;16(9):955-9. doi: 10.1097/00001756-200506210-00015.

Reference Type BACKGROUND
PMID: 15931068 (View on PubMed)

Namer B, Kleggetveit IP, Handwerker H, Schmelz M, Jorum E. Role of TRPM8 and TRPA1 for cold allodynia in patients with cold injury. Pain. 2008 Sep 30;139(1):63-72. doi: 10.1016/j.pain.2008.03.007. Epub 2008 Apr 25.

Reference Type BACKGROUND
PMID: 18440147 (View on PubMed)

Andersen HH, Olsen RV, Moller HG, Eskelund PW, Gazerani P, Arendt-Nielsen L. A review of topical high-concentration L-menthol as a translational model of cold allodynia and hyperalgesia. Eur J Pain. 2014 Mar;18(3):315-25. doi: 10.1002/j.1532-2149.2013.00380.x. Epub 2013 Aug 20.

Reference Type BACKGROUND
PMID: 23963768 (View on PubMed)

Leslie TA, Greaves MW, Yosipovitch G. Current topical and systemic therapies for itch. Handb Exp Pharmacol. 2015;226:337-56. doi: 10.1007/978-3-662-44605-8_18.

Reference Type BACKGROUND
PMID: 25861788 (View on PubMed)

Heyneman CA. Topical nonsteroidal antiinflammatory drugs for acute soft tissue injuries. Ann Pharmacother. 1995 Jul-Aug;29(7-8):780-2. doi: 10.1177/106002809502907-822.

Reference Type BACKGROUND
PMID: 8520097 (View on PubMed)

Andersen HH, Gazerani P, Arendt-Nielsen L. High-Concentration L-Menthol Exhibits Counter-Irritancy to Neurogenic Inflammation, Thermal and Mechanical Hyperalgesia Caused by Trans-cinnamaldehyde. J Pain. 2016 Aug;17(8):919-29. doi: 10.1016/j.jpain.2016.05.004. Epub 2016 May 31.

Reference Type DERIVED
PMID: 27260636 (View on PubMed)

Other Identifiers

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N-20130005

Identifier Type: -

Identifier Source: org_study_id

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