Atopic Dermatitis / EczemaNCT02857062
To Evaluate the in Use Tolerance of E45 Eczema Repair Emollient in Babies and Children With (Very(Dry/Atopic Skin
A study testing E45 Eczema Repair Emollient in people with Atopic Dermatitis / Eczema, run by Reckitt Benckiser Healthcare (UK) Limited.
Trial summary
The investigation will evaluate, under dermatological control, the cutaneous in-use tolerance of E45 Eczema Repair Emollient with two or three times daily application, over a period of two weeks on children and babies with dry/atopic and very dry/atopic skin. Read more about this study
- Who is it for?
- Ages 3 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis / Eczema
- What is being tested?
- E45 Eczema Repair Emollient
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 23 Nov 2016to 2 Feb 2017
- 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 3 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- be female or male
- be a child aged from ≥3 years to < 12 years or a baby aged from ≥3 months to < 36 months at screening
- be phototype I - IV (Fitzpatrick Phototyping Scale)
- have skin that is dry/atopic or very dry/atopic (confirmed by the Dermatologist in consultation with the parent/legal guardian)
- have mild atopic eczema (as confirmed by the Dermatologist in consultation with the parent/legal guardian) but not undergoing steroid treatment for the condition
- have only few or no pigmentation on the selected test site
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- be in general good health and mental condition
- In addition the parent/legal guardian must:
- Both parents in case of shared custody/legal guardian will provide written informed consent for their child/baby to participate in the investigation (children aged 6 years and above, capable of understanding the investigation after it has been explained to them, will be asked to provide assent. Pre-schoolers (2-5 years) will be allowed to express a level of assent verbally relating to their ability to do so)
- agree to attend the investigation centre, with the child/baby, on the predefined days
- be willing and capable to follow the investigation requirements
Who cannot join
- have chronic or acute skin diseases, except atopic eczema on any part of the body
- have an active flare up of atopic eczema on any sites of the body at screening
- known allergy or sensitivity to cosmetic products and/or any ingredients of the investigational product.
- any systemic illness that would impact on the subjects safety or wellbeing and/or affect the response of the skin or the interpretation of the test results at screening (Day -14 to -7)
- receiving the following topical or systemic treatments at baseline (Day 0);
- anti-inflammatory and/or anti-histamines during the previous week
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- cough suppressants and/or topical or inhaled corticosteroids during the previous 2 weeks
- retinoids and/or immunosuppressants during the previous 6 months
- have diabetes, acute cardiac and circulatory diseases, HIV, hepatitis
- participation in other studies/investigations on any part of the body during the last 4 weeks
- use of dermatological therapeutics on the body within 7 days prior to baseline (Day 0) (use of such products on the face, trunk, hands and nappy area is permitted)
- swimming within 48 hours prior to baseline (Day 0)
- intensive/prolonged exposure to the sun within 30 days prior to screening
- planned changes to subject's diet during the investigation (e.g. weaning)
- subjects whose parent/legal guardian are employees or who work for a manufacturer of personal care products or for the testing facility
- subjects in protective care
- subjects whose parent/legal guardian (who will be applying the investigation product) is allergic to the investigation device ingredients
- Any clinically significant and relevant abnormalities of medical history and/or any condition or medication that would impact on the subject safety or well-being and/or affect the response of the skin or the interpretation of the test results in the opinion of the Principal Investigator or designee
About this study
Official title: An Open Label, In-use Tolerance Study in Babies and Children With Dry/Atopic and Very Dry/Atopic Skin, to Evaluate the Acceptability and Skin Tolerability of E45 Eczema Repair Emollient for the Treatment of Atopic or Eczema Prone Skin
The investigation will evaluate, under dermatological control, the cutaneous in-use tolerance of E45 Eczema Repair Emollient with two or three times daily application, over a period of two weeks on children and babies with dry/atopic and very dry/atopic skin.
Read the detailed description
The investigation is an open label, in-use cutaneous tolerance investigation in children and babies with dry/atopic and very dry/atopic skin, to evaluate the acceptability and skin tolerability of E45 Eczema Repair Emollient.
The investigation will be an 'at home' user investigation where the test product will be applied by the parent/legal guardian to a pre-defined test site (arm or leg) between 2 to 3 times daily, consecutively for 14 days.
- Conditions
- Atopic Dermatitis / Eczema
- Being tested
- E45 Eczema Repair Emollient
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E45 Eczema Repair EmollientDevice
E45 Eczema Repair Emollient
| Study group | Role | What they receive |
|---|---|---|
| E45 Eczema Repair Emollient | Experimental | Open label, single arm study to evaluate the skin tolerance of E45 Eczema Repair Emollient in babies and children Receives: Device: E45 Eczema Repair Emollient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous Tolerance
The total irritancy score (Erythema score + Oedema score + Papules score + Vesicles score) for each subject from baseline to end of study as observed by the investigation Dermatologist.
Measured: 14 Days
Parental Assessment of Cutaneous Tolerance
The dermatologist will ask the parent/legal guardian to provide their assessment of tolerance by asking the parent/legal guardian if they considered the product to be well tolerated by their child/baby's skin
Measured: 14 Days
Global Assessment of Cutaneous Tolerance
The dermatologist will make a 'global assessment' of tolerance for each subject based on reported product use/compliance
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start23 Nov 2016
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, in use tolerance study in babies and children.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Intertek
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857062
- Sponsor's protocol ID
- 09224-02
- Status last verified
- Jan 2017
- First submitted
- 28 Jul 2016
- Last updated
- 8 Feb 2017
- 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 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, In-use Tolerance Study in Babies and Children With Dry/Atopic and Very Dry/Atopic Skin, to Evaluate the Acceptability and Skin Tolerability of E45 Eczema Repair Emollient for the Treatment of Atopic or Eczema Prone Skin
- ClinicalTrials.gov ID
- NCT02857062
- Acronym / sponsor ID
- 09224-02
- Conditions
- Atopic Dermatitis / Eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Intertek
- Study start
- 23 Nov 2016 (actual)
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 5 Aug 2016 (estimated)
- 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.
The investigation will evaluate, under dermatological control, the cutaneous in-use tolerance of E45 Eczema Repair Emollient with two or three times daily application, over a period of two weeks on children and babies with dry/atopic and very dry/atopic skin.
Detailed description
The investigation is an open label, in-use cutaneous tolerance investigation in children and babies with dry/atopic and very dry/atopic skin, to evaluate the acceptability and skin tolerability of E45 Eczema Repair Emollient.
The investigation will be an 'at home' user investigation where the test product will be applied by the parent/legal guardian to a pre-defined test site (arm or leg) between 2 to 3 times daily, consecutively for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, in use tolerance study in babies and children.
| Arm | Type | Receives |
|---|---|---|
| E45 Eczema Repair Emollient | Experimental | Device: E45 Eczema Repair EmollientOpen label, single arm study to evaluate the skin tolerance of E45 Eczema Repair Emollient in babies and children |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- be female or male
- be a child aged from ≥3 years to < 12 years or a baby aged from ≥3 months to < 36 months at screening
- be phototype I - IV (Fitzpatrick Phototyping Scale)
- have skin that is dry/atopic or very dry/atopic (confirmed by the Dermatologist in consultation with the parent/legal guardian)
- have mild atopic eczema (as confirmed by the Dermatologist in consultation with the parent/legal guardian) but not undergoing steroid treatment for the condition
Key exclusion criteria (18 listed)
- have chronic or acute skin diseases, except atopic eczema on any part of the body
- have an active flare up of atopic eczema on any sites of the body at screening
- known allergy or sensitivity to cosmetic products and/or any ingredients of the investigational product.
- any systemic illness that would impact on the subjects safety or wellbeing and/or affect the response of the skin or the interpretation of the test results at screening (Day -14 to -7)
- receiving the following topical or systemic treatments at baseline (Day 0);
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 |
|---|---|---|
| E45 Eczema Repair EmollientE45 Eczema Repair Emollient | Device | E45 Eczema Repair Emollient |
Primary outcome
Cutaneous Tolerance
Time frame: 14 Days
The total irritancy score (Erythema score + Oedema score + Papules score + Vesicles score) for each subject from baseline to end of study as observed by the investigation Dermatologist.
Parental Assessment of Cutaneous Tolerance
Time frame: 14 Days
The dermatologist will ask the parent/legal guardian to provide their assessment of tolerance by asking the parent/legal guardian if they considered the product to be well tolerated by their child/baby's skin
Global Assessment of Cutaneous Tolerance
Time frame: 14 Days
The dermatologist will make a 'global assessment' of tolerance for each subject based on reported product use/compliance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing E45 Eczema Repair Emollient in people with Atopic Dermatitis / Eczema, run by Reckitt Benckiser Healthcare (UK) Limited.
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 11 inclusion and 18 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cutaneous Tolerance (time frame: 14 Days). The study lists 3 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 8 Feb 2017.