Dermatitis, AtopicPhase 2NCT03901144
A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier
A Phase 2 study testing 2% urea/20% glycerol cream, Miniderm® 20% cream and Diprobase® cream in people with Dermatitis, Atopic, run by ACO Hud Nordic AB at 1 site in United Kingdom.
Trial summary
Atopic dermatitis (AD) is among the most common chronic types of inflammatory skin disease and it is characterised by exacerbations or relapses over years. The patients have a genetically impaired skin barrier that can be evaluated by measuring the transepidermal water loss (TEWL), which is increased in both dry skin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- 2% urea/20% glycerol cream, Miniderm® 20% cream and Diprobase® cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2019to 10 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants have to meet all of the following criteria to be eligible to enter the study:
- Willing and able to provide informed consent
- Male or female and aged 18 years or above
- Volunteers able to read and understand English
- A personal history of atopic dermatitis
Who cannot join
- Participants meeting any of the following criteria will not be permitted to enter the study:
- Eczema on the volar forearms requiring anti-inflammatory treatment
- Possible allergy to ingredients in the study medications.
- Any serious current medical condition which, in the opinion of the Investigator, may interfere with the evaluation of the results or may be contraindicated by the use of the test medications
- Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy, as judged by the Investigator
- Use of any topical product, including cosmetic leave-on products on the volar forearms, within 1 week prior to, and throughout the study
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- Female participant who, according to the participant, is pregnant or breast-feeding, or plans to become pregnant during the course of the study
- Any participant-related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse), as judged by the Investigator
- Enrolment in any interventional study or use of an investigational drug within 3 months prior to the screening visit
- Volunteers judged by the PI to be inappropriate for the trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Sheffield Medical School
Sheffield, S10 2RX
About this study
Official title: A Phase 2 Randomised Controlled Trial of a NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier in Adults With a Predisposition to a Skin Barrier Defect
Atopic dermatitis (AD) is among the most common chronic types of inflammatory skin disease and it is characterised by exacerbations or relapses over years. The patients have a genetically impaired skin barrier that can be evaluated by measuring the transepidermal water loss (TEWL), which is increased in both dry skin and clinically normal skin in AD patients. Moisturisers are first line treatment for AD patients and moisturisers are the most prescribed products in dermatology. The use of moisturisers have been found to reduce the need for steroids.
The newly developed moisturizing cream 1107.57 is intended for people with dry skin symptoms, such as dryness, itching, and flaking. As most people with dry skin of different origin have an impaired skin barrier function, it is important to investigate the possible influence on the skin barrier after long-term (several weeks') treatment. It is of utmost importance to evaluate different moisturisers head-to-head in order to facilitate an evidence-based choice of moisturiser.
Read more
The primary objective of the trial is to determine whether applying the test cream 1107.57 for 4 weeks is superior in terms of skin barrier strengthening, when compared with (1) no treatment and (2) two reference creams in adults with a predisposition to a skin barrier defect. Secondary objectives are to determine whether there is a difference between 1107.57 and (1) no treatment and (2) the two reference creams in skin moisturization, tolerability, cream consumption and safety.
Participants will treat their lower volar forearms for 28 days with three different creams (test cream and two reference creams) and leave one area untreated as a control. Each forearm will have two different treatment areas and treatment allocation will be randomized. One Finger Tip Unit (FTU) of each cream will be applied twice daily on the designated study area for 28 days. On day 1 and 29 the transepidermal water loss (TEWL) and skin capacitance is measured on their forearms to evaluate the effect on skin barrier function and skin hydration. Furthermore, on day 31, after challenge with 1 % sodium lauryl sulphate (SLS) on day 29, the susceptibility to irritation caused by SLS will be evaluated visually and by measuring TEWL on their forearms. Study participants will attend visits at the start of randomised therapy and on day 5, 15, 29 and 31. During the study period the participants will also grade and evaluate the tolerability of the different creams.
- Conditions
- Dermatitis, Atopic
- Being tested
- 2% urea/20% glycerol cream, Miniderm® 20% cream, Diprobase® cream
- Keywords
- atopic dermatitis, skin barrier, moisturiser, emollient
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% urea/20% glycerol creamDrug
Also called Miniderm Duo 20 mg/g + 200 mg/g cream, Canomini 20 mg/g + 200 mg/g cream
Moisturizing cream for topical application
Miniderm® 20% creamDrug
Moisturizing cream for topical application
Diprobase® creamDrug
Emollient cream for topical application
| Study group | Role | What they receive |
|---|---|---|
| Test cream (2% urea/20% glycerol) | Experimental | Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Receives: Drug: 2% urea/20% glycerol cream |
| Reference cream 1: Miniderm® 20% cream (20% glycerol) | Active comparator | Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Receives: Drug: Miniderm® 20% cream |
| Reference cream 2: Diprobase® cream (cream without humectants) | Active comparator | Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Receives: Drug: Diprobase® cream |
| Untreated | No intervention | Untreated skin area on the volar forearm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Barrier Strengthening Effect by Measurement of Trans Epidermal Water Loss (TEWL) Before and After Induction of Skin Irritation
The change in TEWL from treated and untreated skin before and after induction of skin irritation with SLS. SLS increases TEWL. An effective treatment protects skin from irritation and less TEWL increase is anticipated compared to untreated skin
Measured: day 29 prior to irritant application and day 31 following application
Skin Barrier Strengthening Effect by Measurement of Skin Redness Before and After Induction of Skin Irritation as Assessed by the Erythema Index (Change From Day 29 to Day 31)
Skin redness measurement by Objective Erythema (2D Skin Imaging) on treated and untreated skin before (day 29) and after (day 31) induction of skin irritation with SLS. Captured 2D images are analysed to determine the skin erythema index (degree of redness, arbitrary numerical value), where a higher value denotes a stronger reaction/more redness. An effective treatment is anticipated to protect the skin from irritation, i.e. a weaker reaction from SLS/less redness compared to the untreated skin. Data is presented as change from day 29 to day 31
Measured: The 2D Skin Imaging was performed on day 15, day 29 and on day 31. Only day 29 and 31 was included in the statistical analysis
Skin Barrier Strengthening Effect by Measurement of Skin Redness Before and After Induction of Skin Irritation as Assessed by Mexameter (Change From Day 29 to Day 31)
Objective skin redness measurement by Mexameter on treated and untreated skin before (day 29) and after (day 31) induction of skin irritation with SLS. Skin redness is measured using a C\&K Mexameter probe to quantify SLS-induced skin irritation (arbitrary numerical scale). An effective treatment is anticipated to protect the skin from irritation, i.e. a weaker reaction from SLS/less redness compared to the untreated skin. Data is presented as change from day 29 to day 31
Measured: Measured on day 29 and 31
Skin Barrier Strengthening Effect by Measurement of Skin Redness Before Induction of Skin Irritation as Assessed by Visual Scoring
Skin redness by visual scoring on treated and untreated skin before induction of skin irritation with SLS. Skin redness was evaluated on a 4-point visual scale from 0 to 3, where 0 indicates no redness/reaction and 3 indicates strong erythema.
Measured: Skin redness was scored on day 29
Skin Barrier Strengthening Effect by Measurement of Skin Redness After Induction of Skin Irritation as Assessed by Visual Scoring
Skin redness by visual scoring on treated and untreated skin after induction of skin irritation with SLS. Skin redness was evaluated on a 4-point visual scale from 0 to 3, where 0 indicates no redness/reaction and 3 indicates strong erythema.
Measured: Skin redness was scored on day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start21 Feb 2019
- Primary completion29 Nov 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, AtopicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Every patient use three different creams (1 test cream, 2 reference creams) and one untreated area. They are their own controls
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACO Hud Nordic AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901144
- Sponsor's protocol ID
- Novum ACO-CT-2018-01
- Other IDs
- 2018-002945-12, 2018
- Status last verified
- Dec 2021
- First submitted
- 1 Apr 2019
- Last updated
- 20 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomised Controlled Trial of a NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier in Adults With a Predisposition to a Skin Barrier Defect
- ClinicalTrials.gov ID
- NCT03901144
- Acronym / sponsor ID
- Novum ACO-CT-2018-01
- Conditions
- Dermatitis, Atopic
- Keywords
- atopic dermatitis, skin barrier, moisturiser, emollient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ACO Hud Nordic ABIndustry (pharma, biotech, devices)
- Collaborators
- University of Sheffield
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Posted 20 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atopic dermatitis (AD) is among the most common chronic types of inflammatory skin disease and it is characterised by exacerbations or relapses over years. The patients have a genetically impaired skin barrier that can be evaluated by measuring the transepidermal water loss (TEWL), which is increased in both dry skin and clinically normal skin in AD patients. Moisturisers are first line treatment for AD patients and moisturisers are the most prescribed products in dermatology. The use of moisturisers have been found to reduce the need for steroids.
The newly developed moisturizing cream 1107.57 is intended for people with dry skin symptoms, such as dryness, itching, and flaking. As most people with dry skin of different origin have an impaired skin barrier function, it is important to investigate the possible influence on the skin barrier after long-term (several weeks') treatment. It is of utmost importance to evaluate different moisturisers head-to-head in order to facilitate an evidence-based choice of moisturiser.
The primary objective of the trial is to determine whether applying the test cream 1107.57 for 4 weeks is superior in terms of skin barrier strengthening, when compared with (1) no treatment and (2) two reference creams in adults with a predisposition to a skin barrier defect. Secondary objectives are to determine whether there is a difference between 1107.57 and (1) no treatment and (2) the two reference creams in skin moisturization, tolerability, cream consumption and safety.
Participants will treat their lower volar forearms for 28 days with three different creams (test cream and two reference creams) and leave one area untreated as a control. Each forearm will have two different treatment areas and treatment allocation will be randomized. One Finger Tip Unit (FTU) of each cream will be applied twice daily on the designated study area for 28 days. On day 1 and 29 the transepidermal water loss (TEWL) and skin capacitance is measured on their forearms to evaluate the effect on skin barrier function and skin hydration. Furthermore, on day 31, after challenge with 1 % sodium lauryl sulphate (SLS) on day 29, the susceptibility to irritation caused by SLS will be evaluated visually and by measuring TEWL on their forearms. Study participants will attend visits at the start of randomised therapy and on day 5, 15, 29 and 31. During the study period the participants will also grade and evaluate the tolerability of the different creams.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Every patient use three different creams (1 test cream, 2 reference creams) and one untreated area. They are their own controls
| Arm | Type | Receives |
|---|---|---|
| Test cream (2% urea/20% glycerol) | Experimental | Drug: 2% urea/20% glycerol creamTopical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days |
| Reference cream 1: Miniderm® 20% cream (20% glycerol) | Active comparator | Drug: Miniderm® 20% creamTopical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days |
| Reference cream 2: Diprobase® cream (cream without humectants) | Active comparator | Drug: Diprobase® creamTopical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days |
| Untreated | No intervention | –Untreated skin area on the volar forearm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The participants have to meet all of the following criteria to be eligible to enter the study:
- Willing and able to provide informed consent
- Male or female and aged 18 years or above
- Volunteers able to read and understand English
- A personal history of atopic dermatitis
Key exclusion criteria (10 listed)
- Participants meeting any of the following criteria will not be permitted to enter the study:
- Eczema on the volar forearms requiring anti-inflammatory treatment
- Possible allergy to ingredients in the study medications.
- Any serious current medical condition which, in the opinion of the Investigator, may interfere with the evaluation of the results or may be contraindicated by the use of the test medications
- Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy, as judged by the Investigator
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 |
|---|---|---|
| 2% urea/20% glycerol creamAlso: Miniderm Duo 20 mg/g + 200 mg/g cream, Canomini 20 mg/g + 200 mg/g creamMoisturizing cream for topical application | Drug | Test cream (2% urea/20% glycerol) |
| Miniderm® 20% creamMoisturizing cream for topical application | Drug | Reference cream 1: Miniderm® 20% cream (20% glycerol) |
| Diprobase® creamEmollient cream for topical application | Drug | Reference cream 2: Diprobase® cream (cream without humectants) |
Primary outcome
Skin Barrier Strengthening Effect by Measurement of Trans Epidermal Water Loss (TEWL) Before and After Induction of Skin Irritation
Time frame: day 29 prior to irritant application and day 31 following application
The change in TEWL from treated and untreated skin before and after induction of skin irritation with SLS. SLS increases TEWL. An effective treatment protects skin from irritation and less TEWL increase is anticipated compared to untreated skin
Skin Barrier Strengthening Effect by Measurement of Skin Redness Before and After Induction of Skin Irritation as Assessed by the Erythema Index (Change From Day 29 to Day 31)
Time frame: The 2D Skin Imaging was performed on day 15, day 29 and on day 31. Only day 29 and 31 was included in the statistical analysis
Skin redness measurement by Objective Erythema (2D Skin Imaging) on treated and untreated skin before (day 29) and after (day 31) induction of skin irritation with SLS. Captured 2D images are analysed to determine the skin erythema index (degree of redness, arbitrary numerical value), where a higher value denotes a stronger reaction/more redness. An effective treatment is anticipated to protect the skin from irritation, i.e. a weaker reaction from SLS/less redness compared to the untreated skin. Data is presented as change from day 29 to day 31
Skin Barrier Strengthening Effect by Measurement of Skin Redness Before and After Induction of Skin Irritation as Assessed by Mexameter (Change From Day 29 to Day 31)
Time frame: Measured on day 29 and 31
Objective skin redness measurement by Mexameter on treated and untreated skin before (day 29) and after (day 31) induction of skin irritation with SLS. Skin redness is measured using a C\&K Mexameter probe to quantify SLS-induced skin irritation (arbitrary numerical scale). An effective treatment is anticipated to protect the skin from irritation, i.e. a weaker reaction from SLS/less redness compared to the untreated skin. Data is presented as change from day 29 to day 31
Skin Barrier Strengthening Effect by Measurement of Skin Redness Before Induction of Skin Irritation as Assessed by Visual Scoring
Time frame: Skin redness was scored on day 29
Skin redness by visual scoring on treated and untreated skin before induction of skin irritation with SLS. Skin redness was evaluated on a 4-point visual scale from 0 to 3, where 0 indicates no redness/reaction and 3 indicates strong erythema.
Skin Barrier Strengthening Effect by Measurement of Skin Redness After Induction of Skin Irritation as Assessed by Visual Scoring
Time frame: Skin redness was scored on day 31
Skin redness by visual scoring on treated and untreated skin after induction of skin irritation with SLS. Skin redness was evaluated on a 4-point visual scale from 0 to 3, where 0 indicates no redness/reaction and 3 indicates strong erythema.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2% urea/20% glycerol cream, Miniderm® 20% cream and Diprobase® cream in people with Dermatitis, Atopic, run by ACO Hud Nordic AB at 1 site in United Kingdom.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 20 Dec 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 United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Skin Barrier Strengthening Effect by Measurement of Trans Epidermal Water Loss (TEWL) Before and After Induction of Skin Irritation (time frame: day 29 prior to irritant application and day 31 following application). The study lists 5 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 20 Dec 2021.