The Effect of Halophyte-based Cream on Pain and Itch

Aalborg University

Status: Completed

Conditions: Itch; Pain, Acute

Treatments: Other: Halophites-based cream 48 hours; Other: Halophites-based cream 24 hours; Other: Vehicle cream 48 hours; Other: Cowhage; Other: Histamine 1%; Other: Vehicle cream 24 hours

Study type: Interventional

Funder types: Other

Identifiers

NCT04635254

N-20200072

Details and patient eligibility

About

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.

Full description

Salt-tolerant plants (also called halophytes) can grow in saline soil or directly in salt water (e.g. along coasts). For centuries, these plants have been used in folk medicine, and among other things they are believed to have pain-relieving and anti-inflammatory effect.

Even though experiments have already investigated halophytes as a pain relieving substance, the mechanisms in relation to pain and/or itch are still unknown. Therefore, 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women
• 18-60 years
• 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 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Halophites-based cream 24 hours

Active Comparator group

Description:

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

Treatment:

Other: Histamine 1%

Other: Cowhage

Other: Halophites-based cream 24 hours

Other: Vehicle cream 24 hours

Halophites-based cream 48 hours

Active Comparator group

Description:

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

Treatment:

Other: Histamine 1%

Other: Cowhage

Other: Vehicle cream 48 hours

Other: Halophites-based cream 48 hours