NCT04635254

Brief Summary

In this study the investigators wish to investigate whether halophyte-based cream applied to the skin can reduce itch applied by means of small needles from the plant mucuna pruriens (also called cowhage) or by histamine (an itch-evoking substance formed in the human body). Further, the investigators wishes to investigate whether long-term application of halophyte-based cream has a pain-relieving effect on heat/cold and pinprick stimulations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

November 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

October 28, 2020

Last Update Submit

January 17, 2022

Conditions

Pain, AcuteItch

Outcome Measures

Primary Outcomes (15)

  • Superficial blood perfusion

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

    Day 0

  • Superficial blood perfusion

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

    24 hours after cream application

  • Superficial blood perfusion

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

    48 hours after cream application

  • Itch intensity

    The subject will rate the itch sensation on a 100 millimeter Visual Analog Scale from 0 to 100., where 0"indicates no itch and "100" worst itch imaginable

    Day 0

  • Itch intensity

    The subject will rate the itch sensation on a 100 millimeter Visual Analog Scale from 0 to 100., where 0"indicates no itch and "100" worst itch imaginable

    24 hours after cream application

  • Itch intensity

    The subject will rate the itch sensation on a 100 millimeter Visual Analog Scale from 0 to 100., where 0"indicates no itch and "100" worst itch imaginable

    48 hours after cream application

  • Pain intensity

    The subject will rate the pain sensation on a 100 millimeter Visual Analog Scale from 0 to 100., where 0"indicates no pain and "100" worst pain imaginable

    Day 0

  • Pain intensity

    The subject will rate the pain sensation on a 100 millimeter Visual Analog Scale from 0 to 100., where 0"indicates no pain and "100" worst pain imaginable

    24 hours after cream application

  • Pain intensity

    The subject will rate the pain sensation on a 100 millimeter Visual Analog Scale from 0 to 100., where 0"indicates no pain and "100" worst pain imaginable

    48 hours after cream application

  • Measuring Alloknesis

    Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).

    Day 0

  • Measuring Alloknesis

    Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).

    24 hours after cream application

  • Measuring Alloknesis

    Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).

    48 hours after cream application

  • Trans-epidermal Water Loss (TEWL)

    TEWL is a non-invasive and pain free measuring technique in which a 2x2 cm hollow probe with two small humidity gauges and two thermometers is placed lightly on the skin for 10-25 seconds. These collectively establish a precise humidity gradient in a 2 cm vicinity of the skin, representative for the point-loss of water though the epidermis.

    Day 0

  • Trans-epidermal Water Loss (TEWL)

    TEWL is a non-invasive and pain free measuring technique in which a 2x2 cm hollow probe with two small humidity gauges and two thermometers is placed lightly on the skin for 10-25 seconds. These collectively establish a precise humidity gradient in a 2 cm vicinity of the skin, representative for the point-loss of water though the epidermis.

    24 hours after cream application

  • Trans-epidermal Water Loss (TEWL)

    TEWL is a non-invasive and pain free measuring technique in which a 2x2 cm hollow probe with two small humidity gauges and two thermometers is placed lightly on the skin for 10-25 seconds. These collectively establish a precise humidity gradient in a 2 cm vicinity of the skin, representative for the point-loss of water though the epidermis.

    48 hours after cream application

Secondary Outcomes (21)

  • Measurement of Warm Detection Thresholds (WDT)

    Day 0

  • Measurement of Warm Detection Thresholds (WDT)

    24 hours after cream application

  • Measurement of Warm Detection Thresholds (WDT)

    48 hours after cream application

  • Measurement of Cold Detection Thresholds (CDT)

    Day 0

  • Measurement of Cold Detection Thresholds (CDT)

    24 hours after cream application

  • +16 more secondary outcomes

Study Arms (2)

Halophites-based cream 24 hours

ACTIVE COMPARATOR

A 2 gram amount of Halophites-based cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.

Other: Halophites-based cream 24 hoursOther: Vehicle cream 24 hoursOther: Histamine 1%Other: Cowhage

Halophites-based cream 48 hours

ACTIVE COMPARATOR

A 2 gram amount of Halophites-based cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.

Other: Halophites-based cream 48 hoursOther: Vehicle cream 48 hoursOther: Histamine 1%Other: Cowhage

Interventions

Halophites-based cream 24 hoursOTHER

The concentration of active aqueous extract will be in the range of 2% to 30% (v/v) by cold emulsification. A 2 gram amount of Halophytes-based cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.

Halophites-based cream 24 hours
Halophites-based cream 48 hoursOTHER

The concentration of active aqueous extract will be in the range of 2% to 30% (v/v) by cold emulsification. A 2 gram amount of Halophytes-based cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.

Halophites-based cream 48 hours
Vehicle cream 24 hoursOTHER

A 2 gram amount of vehicle cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.

Halophites-based cream 24 hours
Vehicle cream 48 hoursOTHER

A 2 gram amount of vehicle cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.

Halophites-based cream 48 hours
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.

Halophites-based cream 24 hoursHalophites-based cream 48 hours
CowhageOTHER

The insertion of cowhage spicule(s) rapidly and consistently produces itch with no or very little flare reaction. This insertion is conducted by forceps using a stereo-microscope, and 30-35 spicules are gently rubbed into a 1 cm diameter skin area.

Halophites-based cream 24 hoursHalophites-based cream 48 hours

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • years
  • Speak and understand English

You may not qualify if:

  • Pregnancy or lactation
  • Drug addiction defined as any use of cannabis, opioids or other drugs
  • Previous or current neurologic, musculoskeletal or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
  • Lack of ability to cooperate
  • Current use of medications that may affect the trial such as antihistamine medications or pain killers
  • Skin diseases
  • Consumption of alcohol or painkillers 24 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Acute PainPruritus

Interventions

Tumor Protein, Translationally-Controlled 1

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin Manifestations

Intervention Hierarchy (Ancestors)

Intracellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsNeoplasm Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 19, 2020

Study Start

November 12, 2020

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

January 19, 2022

Record last verified: 2022-01

Locations

DK(1)