NCT04635254

The Effect of Halophyte-based Cream on Pain and Itch

Effects of Halophyte-based Cream Skin Application in a Human Experimental Model of Pain and Itch

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Aalborg University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pain, Acute
• Itch

Interventions

Type	Name	Description
OTHER	Halophites-based cream 24 hours	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.
OTHER	Halophites-based cream 48 hours	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.
OTHER	Vehicle cream 24 hours	A 2 gram amount of vehicle cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.
OTHER	Vehicle cream 48 hours	A 2 gram amount of vehicle cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.
OTHER	Histamine 1%	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.
OTHER	Cowhage	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.

Timeline

• Start date: 2020-11-12
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2020-11-19
• Last updated: 2022-01-19

Locations

1 site across 1 country: Denmark