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Effects of a Berry Oil Cream on Atopic Eczema and Skin

Primary Purpose

Atopic Dermatitis Eczema

Status

Terminated

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Berry Oil Cream

Reference Cream

About this trial

This is an interventional treatment trial for Atopic Dermatitis Eczema

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Mehiläinen (Private Clinic)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Active Comparator

Arm Label

Berry Oil Cream

Control

Reference cream

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Change in severity of symptoms

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

Change in sensation of itch

Visual Analog Scale (VAS) evaluation. Scale range 0-10. Decrease indicates better outcome/ milder symptoms.

Change in transepidermal water loss (TEWL)

Measurement of TEWL (g/m2h)

Change in skin hydration

Measurement of moisture (capacitance, proportional to water content of skin)

Change in skin pH

Measurement of skin pH

Secondary Outcome Measures

Change in symptoms of itching, dryness, flaking of skin

Symptom logbooks: daily scoring from 0 (no symptoms) to 3 (severe symptoms)

Full Information

NCT ID

NCT04085549

First Posted

September 9, 2019

Last Updated

January 11, 2021

Sponsor

Petra Larmo

Collaborators

Cliniscan Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04085549

Brief Title

Effects of a Berry Oil Cream on Atopic Eczema and Skin

Official Title

Effects of a Berry Oil Cream on Atopic Eczema and Skin

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

Study was ceased due to Covid-19 epidemia.

Study Start Date

October 9, 2019 (Actual)

Primary Completion Date

April 15, 2020 (Actual)

Study Completion Date

April 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Petra Larmo

Collaborators

Cliniscan Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis Eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Berry Oil Cream

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm 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.

Arm Title

Reference cream

Arm Type

Active Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

Berry Oil Cream

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Reference Cream

Intervention Description

Commercial refence cream not containing berry and plant oils.

Primary Outcome Measure Information:

Title

Change in severity of atopic eczema

Description

Time Frame

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

Title

Change in severity of symptoms

Description

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

Time Frame

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

Title

Change in sensation of itch

Description

Visual Analog Scale (VAS) evaluation. Scale range 0-10. Decrease indicates better outcome/ milder symptoms.

Time Frame

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

Title

Change in transepidermal water loss (TEWL)

Description

Measurement of TEWL (g/m2h)

Time Frame

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

Title

Change in skin hydration

Description

Measurement of moisture (capacitance, proportional to water content of skin)

Time Frame

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

Title

Change in skin pH

Description

Measurement of skin pH

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in symptoms of itching, dryness, flaking of skin

Description

Symptom logbooks: daily scoring from 0 (no symptoms) to 3 (severe symptoms)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Risto Oksman, MD

Organizational Affiliation

Cliniscan Ltd

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mehiläinen (Private Clinic)

City

Turku

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of a Berry Oil Cream on Atopic Eczema and Skin

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