Atopic Dermatitis EczemaNCT04085549
Effects of a Berry Oil Cream on Atopic Eczema and Skin
A study testing Berry Oil Cream and Reference Cream in people with Atopic Dermatitis Eczema, run by Petra Larmo at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Atopic Dermatitis Eczema
- What is being tested?
- Berry Oil Cream and Reference Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFinland
- Study dates
- 9 Oct 2019to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Atopic Eczema (mild or medium severity)
Who cannot join
- Other serious skin conditions (for example psoriasis)
- Known hypersensitivity to ingredients of the study creams
- Medication seriously affecting immune function
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Atopic Dermatitis Eczema
- Being tested
- Berry Oil Cream, Reference Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Berry Oil Cream | Experimental | 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. Receives: Device: Berry Oil Cream |
| Control | No intervention | 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. |
| Reference cream | Active comparator | 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. Receives: Other: Reference Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Change in transepidermal water loss (TEWL)
Measurement of TEWL (g/m2h)
Measured: 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)
Measured: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Change in skin pH
Measurement of skin pH
Measured: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Secondary outcomes (1)
Change in symptoms of itching, dryness, flaking of skin
Symptom logbooks: daily scoring from 0 (no symptoms) to 3 (severe symptoms)
Measured: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start9 Oct 2019
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Why it stopped: Study was ceased due to Covid-19 epidemia.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petra Larmo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cliniscan Ltd
- Responsible party
- Sponsor-investigator, Petra Larmo, Aromtech Ltd.
- Investigators
- Risto Oksman, MD, Principal investigator, Cliniscan Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085549
- Sponsor's protocol ID
- BOAE
- Status last verified
- Jan 2021
- First submitted
- 9 Sep 2019
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Berry Oil Cream on Atopic Eczema and Skin
- ClinicalTrials.gov ID
- NCT04085549
- Acronym / sponsor ID
- BOAE
- Conditions
- Atopic Dermatitis Eczema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was ceased due to Covid-19 epidemia.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Petra LarmoIndustry (pharma, biotech, devices)
- Collaborators
- Cliniscan Ltd
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Berry Oil Cream | Experimental | Device: Berry Oil CreamStudy 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. |
| Control | No intervention | –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. |
| Reference cream | Active comparator | Other: Reference CreamA commercial reference cream, not containing berry and plant oils. Study part 2: Administered to randomized body half 1-2 times/d for five weeks. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Atopic Eczema (mild or medium severity)
Key exclusion criteria (3 listed)
- Other serious skin conditions (for example psoriasis)
- Known hypersensitivity to ingredients of the study creams
- Medication seriously affecting immune function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berry Oil CreamCream containing berry and plant oils and humectants; a medical device product in development | Device | Berry Oil Cream |
| Reference CreamCommercial refence cream not containing berry and plant oils. | Other | Reference cream |
Primary outcome
Change in severity of atopic eczema
Time frame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 5 weeks
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
Time frame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Modified Patient Oriented Eczema Measure (POEM) questionnaire. Scale range: 0-24. Decrease indicates better outcome/ milder symptoms.
Change in sensation of itch
Time frame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Visual Analog Scale (VAS) evaluation. Scale range 0-10. Decrease indicates better outcome/ milder symptoms.
Change in transepidermal water loss (TEWL)
Time frame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Measurement of TEWL (g/m2h)
Change in skin hydration
Time frame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Measurement of moisture (capacitance, proportional to water content of skin)
Change in skin pH
Time frame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Measurement of skin pH
1 secondary outcome
Change in symptoms of itching, dryness, flaking of skin
Time frame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Results and safety
The study was stopped early (reason given: Study was ceased due to Covid-19 epidemia.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Risto Oksman, MD principal investigator
Cliniscan Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berry Oil Cream and Reference Cream in people with Atopic Dermatitis Eczema, run by Petra Larmo at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was ceased due to Covid-19 epidemia.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of atopic eczema (time frame: Part 1: Baseline, 2 weeks. Part 2: Baseline, 5 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.