Effects of a Berry Oil Cream on Atopic Eczema and Skin

Study Overview
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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.

Official Title
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Effects of a Berry Oil Cream on Atopic Eczema and Skin

Conditions
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Atopic Dermatitis Eczema

Intervention / Treatment
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* Device: Berry Oil Cream
* Other: Reference Cream


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Berry Oil Cream<br>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. | Device: Berry Oil Cream<br>* Cream containing berry and plant oils and humectants; a medical device product in development<br>|
| No Intervention: Control<br>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. | |
| Active Comparator: Reference cream<br>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. | Other: Reference Cream<br>* Commercial refence cream not containing berry and plant oils.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks | 
| Change in sensation of itch | Visual Analog Scale (VAS) evaluation. Scale range 0-10. Decrease indicates better outcome/ milder symptoms. | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks | 
| Change in transepidermal water loss (TEWL) | Measurement of TEWL (g/m2h) | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks | 
| Change in skin hydration | Measurement of moisture (capacitance, proportional to water content of skin) | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks | 
| Change in skin pH | Measurement of skin pH | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptoms of itching, dryness, flaking of skin | Symptom logbooks: daily scoring from 0 (no symptoms) to 3 (severe symptoms) | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks |