A Mechanistic Evaluation of the Nociceptive Desensitizing Properties of Topical Capsaicin

Aalborg University

Status: Completed

Conditions: Neuropathic Pain; Lidocaine; Ultaviolet B Light Burn; Capsaicin

Treatments: Other: Histamine 1%; Drug: Capsaicin Topical; Radiation: Ultraviolet-B (UVB) irradiation; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03587220

N-20180034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women
• 18-60 years
• Caucasian descent (only in sub-study 1)
• Speak and understand English

Exclusion criteria

• 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
• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Capsaicin+UVB group

Experimental group

Description:

All subjects will be treated with capsaicin, placebo + UVB, or Capsaicin+UVB.

Treatment:

Drug: Capsaicin Topical

Radiation: Ultraviolet-B (UVB) irradiation

Capsaicin + EMLA group

Experimental group

Description:

All subjects will be pre-treated with lidocain cream before capsaicin application

Treatment:

Drug: Lidocaine

Drug: Capsaicin Topical

Other: Histamine 1%