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

NCT03132142 | Unknown

• 1 other identifier: N-20170018
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Pruritus; Neuropathic Pain; Dermatology/Skin - Other

Outcome Measures

Primary Outcomes (2)

• 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.

  Assessed at 5 visits on 5 consecutive days

• Heat Pain Threshold (HPT)

  The pain threshold for heat stimulation

  Assessed at 5 visits on 5 consecutive days

Secondary Outcomes (12)

• Neurogenic Inflammation Intensity

  Assessed before and after application of substances at 5 visits on 5 consecutive days

• Neurogenic Inflammation Area

  Assessed before and after application of substances at 5 visits on 5 consecutive days

• Pain During Application of Capsaicin

  Assessed every 5 minutes during the 60 minute application of capsaicin at 4 visits on 4 consecutive days

• Pain During Application of Trans-cinnamaldehyde

  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

  Assessed every 5 minutes during the 60 minute application of L-menthol at 4 visits on 4 consecutive days

Study Arms (4)

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.

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.

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.

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.

Drug: Vehicle patch

Interventions

Capsaicin 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

Capsaicin

Trans-cinnamaldehyde DRUG

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

Trans-cinnamaldehyde

L-Menthol DRUG

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

L-menthol

Vehicle patch DRUG

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

Vehicle patch

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Speaks and understands English or Danish
• years

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

SMI

Aalborg, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Pain; Pruritus; Neuralgia

Interventions

Capsaicin; cinnamaldehyde; Menthol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Monoterpenes; Terpenes

Central Study Contacts

Lars Arendt-Nielsen, Professor

CONTACT

0045 99408830; lan@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc. Med., Phd. Stud.

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: April 27, 2017
• Study Start: April 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)