Effects of a Berry Oil Cream on Atopic Eczema and Skin

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 Overview

• Status: Terminated
• Conditions: Atopic Dermatitis Eczema
• Intervention / Treatment: Device: Berry Oil Cream; Other: Reference Cream

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland
    • Mehiläinen (Private Clinic)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Petra Larmo
• Collaborators: Cliniscan Ltd
• Investigators: Principal Investigator: Risto Oksman, MD, Cliniscan Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Actual): April 15, 2020
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: BOAE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No