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Completed

NCT Number: NCT03587220

A Mechanistic Evaluation of the Nociceptive Desensitizing Properties of Topical 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Silvia Lo Vecchio

Aalborg, North Denmark, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capsaicin Topical

Drug

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) irradiation

Radiation

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.

Lidocaine

Drug

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)

Primary outcomes

  1. Superficial blood perfusion measured by a Speckle contrast imager (FLPI, Moor Instruments, England).

    Time frame: Changes from baseline to 7 days after intervention

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. assessment of pain rating by using a visual analog scales (VAS)

    Time frame: Change from baseline to 24 h

    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').

  2. Itch rating by using a visual analog scales (VAS)

    Time frame: Changes from baseline to 7 days after intervention

    Itch is monitored for 9 minutes using a visual analog scale from 0 indicating 'no itch' to100 indicating 'worst imaginable itch.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

En undersøgelse af Mekanismerne Bag Nociceptiv Desensibilisering forårsaget af Topikal Capsaicin

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2018
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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