Effects of a Berry Oil Cream on Atopic Eczema and Skin

Petra Larmo83 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis Eczema

Interventions

Berry Oil CreamDEVICE

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

Reference CreamOTHER

Commercial refence cream not containing berry and plant oils.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Mehiläinen (Private Clinic)

Turku, Finland

Outcomes

Primary Outcomes

Change in severity of atopic eczema

Objective local Scoring Atopic Dermatitis (SCORAD) index. Scale range for objective local scorad in study part 1 (chosen eczema lesion) 0-63, in study part 2 (body half) 0-73. Decrease indicates better outcome/ milder symptoms.

Time frame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 5 weeks

Change in severity of symptoms

Modified Patient Oriented Eczema Measure (POEM) questionnaire. Scale range: 0-24. Decrease indicates better outcome/ milder symptoms.