Effects of a Berry Oil Cream on Atopic Eczema and Skin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-09

Study Completion Date

2020-04-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study has two parts. In part 1 the participants, care provider and outcome assessor know which treatment is given to each skin area. In part 2 participant, care provider, investigator and outcome assessor do not know which treatment is given to each skin area. Masking is done by identical cream tubes.

Study Groups

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Berry Oil Cream

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.

Group Type EXPERIMENTAL

Berry Oil Cream

Intervention Type DEVICE

Cream containing berry and plant oils and humectants; a medical device product in development

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Reference cream

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.

Group Type ACTIVE_COMPARATOR

Reference Cream

Intervention Type OTHER

Commercial refence cream not containing berry and plant oils.

Interventions

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Berry Oil Cream

Cream containing berry and plant oils and humectants; a medical device product in development

Intervention Type DEVICE

Reference Cream

Commercial refence cream not containing berry and plant oils.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No