Desensitization of Nociceptive Afferents by Application of Topical Capsaicin, Trans-cinnamaldehyde and L-menthol

NCT ID: NCT03132142

Last Updated: 2017-04-27

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-30

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

1. F. Henrich et al. 2015 "Capsaicin-sensitive C- and A-fibre nociceptors control long-term potentiation-like pain amplification in humans"
2. 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

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Pain Pruritus Neuropathic Pain Dermatology/Skin - Other

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Capsaicin

Capsacin (8%) patches applied topically 4 times for 1 hour to a 4x4 cm predefined area on the skin of the volar forearms.

Group Type EXPERIMENTAL

Capsaicin

Intervention Type DRUG

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-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.

Group Type EXPERIMENTAL

Trans-cinnamaldehyde

Intervention Type DRUG

1mL of 10% trans-cinnamaldehyde applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days

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.

Group Type EXPERIMENTAL

L-Menthol

Intervention Type DRUG

1mL of 40% L-menthol applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days

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.

Group Type PLACEBO_COMPARATOR

Vehicle patch

Intervention Type DRUG

Inert vehicle patch applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days

Interventions

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Capsaicin

4x4 cm patch of 8% topical capsaicin applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days

Intervention Type DRUG

Trans-cinnamaldehyde

1mL of 10% trans-cinnamaldehyde applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days

Intervention Type DRUG

L-Menthol

1mL of 40% L-menthol applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days

Intervention Type DRUG

Vehicle patch

Inert vehicle patch applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Hjalte Holm Andersen

MSc. Med., Phd. Stud.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SMI

Aalborg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lars Arendt-Nielsen, Professor

Role: CONTACT

0045 99408830

Facility Contacts

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Hjalte H Andersen, MSc. Med.

Role: primary

0045 24464515

Other Identifiers

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N-20170018

Identifier Type: -

Identifier Source: org_study_id

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