Effects of a Berry Oil Cream on Atopic Eczema and Skin

Aromtech

Status: Terminated

Conditions: Atopic Dermatitis Eczema

Treatments: Other: Reference Cream; Device: Berry Oil Cream

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04085549

BOAE

Details and patient eligibility

About

Atopic eczema is a chronic inflammatory skin disease associated with itch and inflammatory lesions in typical skin areas. The objective of this study is to investigate the effects of a cream containing berry and plant oils and humectants on atopic eczema and dry skin.

Enrollment: 83 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Atopic Eczema (mild or medium severity)

Exclusion criteria

• Other serious skin conditions (for example psoriasis)
• Known hypersensitivity to ingredients of the study creams
• Medication seriously affecting immune function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 3 patient groups

Berry Oil Cream

Experimental group

Description:

Study part 1: Administered to a chosen eczema lesion on randomized body half 1-2 times/d or more frequently (use reported to study logbook) for two weeks. Also administered to forearm (randomized body half) twice/d for two weeks. Study part 2: Administered to randomized body half 1-2 times/d for five weeks.

Treatment:

Device: Berry Oil Cream

Control

No Intervention group

Description:

Study part 1: A chosen eczema lesion on randomized body half is an untreated control for two weeks. Also one forearm (on randomized body half) is a control with no treatment for two weeks.

Reference cream

Active Comparator group

Description:

A commercial reference cream, not containing berry and plant oils. Study part 2: Administered to randomized body half 1-2 times/d for five weeks.

Treatment:

Other: Reference Cream