Atopic DermatitisNCT05318300
Evaluation of an Adapted Formula on Atopic Dermatitis.
A study testing tested formula with fiber in people with Atopic Dermatitis, run by United Pharmaceuticals at 3 sites in 2 countries.
Trial summary
The aim of this study is to show the efficiency of a new infant formula containing fiber on the management of moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 1 month to 18 months
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- tested formula with fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 May 2022to Apr 2024
- 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 1 month to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged below 18 month
- Having an atopic dermatitis diagnosed according to the United Kingdom Working Party - Having an Eczema Area Severity Index (EASI) between 7.1 and 50.0
- Whose parents gave their informed consent
Who cannot join
- systemic corticotherapy
- antihistamine
- use of dermocorticoide and/or antibiotics within 15 days
- symptoms of cutaneous infection
- Past anaphylactic shock
- cow's milk, soya or fish allergy
Show all 9Show fewer
- Exclusive or predominant breast feediing (more than one feeding/day)
- Consumption of less than 500 ml per day
- Participation to another trial.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Assessment of the Effect of Cow's Milk Protein-based Formulas for Infants in the Management of Moderate to Severe aTOPic Dermatitis in Infants Aged Less Than 18 Months
The aim of this study is to show the efficiency of a new infant formula containing fiber on the management of moderate to severe atopic dermatitis.
Read the detailed description
The study is double blind randomized where the new formula is compared to a placebo during 3 months followed by a period of 3 months optional. During this period of time, all infant include in the study will be fed with the study formula.
- Conditions
- Atopic Dermatitis
- Being tested
- tested formula with fiber, Control
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tested formula with fiberDietary supplement
formula containing fibers
ControlDietary supplement
formula without fiber
| Study group | Role | What they receive |
|---|---|---|
| Tested formula LP-2018 | Experimental | infant formula containing fibers Receives: Dietary Supplement: tested formula with fiber |
| Placebo formula CT-2018 | Placebo comparator | infant formula without fibers Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
EASI (Eczema Area Severity Index) score after 90 days.
evolution of the EASI score between day 0 to day 90. The score range is between 0 (no eczema) and 72 (highest score of eczema)
Measured: 90 days
Secondary outcomes (64)
EASI (Eczema Area Severity Index) score after 30 days.
evolution of the EASI score between day 0 to day 30. The score range is between 0 (no eczema) and 72 (highest score of eczema)
Measured: 30 days
EASI (Eczema Area Severity Index) score after 60 days.
evolution of the EASI score between day 0 to day 60. The score range is between 0 (no eczema) and 72 (highest score of eczema)
Measured: 60 days
EASI (Eczema Area Severity Index) score after 180 days.
evolution of the EASI score between day 0 to day 180. The score range is between 0 (no eczema) and 72 (highest score of eczema)
Measured: 180 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Area under the curve of PO SCORAD
Measured: 30 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Area under the curve of PO SCORAD
Measured: 60 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Area under the curve of PO SCORAD
Measured: 90 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Area under the curve of PO SCORAD
Measured: 180 days
Skin dryness
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Measured: 30 days
Skin dryness
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Measured: 60 days
Skin dryness
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Measured: 90 days
Skin dryness
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Measured: 180 days
Itching
Evolution of itching evaluated by the investigator using an analogic visual scale
Measured: 30 days
Itching
Evolution of itching evaluated by the investigator using an analogic visual scale
Measured: 60 days
Itching
Evolution of itching evaluated by the investigator using an analogic visual scale
Measured: 90 days
Itching
Evolution of itching evaluated by the investigator using an analogic visual scale
Measured: 180 days
Quality of sleep (assessed by VAS)
Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles)
Measured: 30 days
Quality of sleep (assessed by VAS)
Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles)
Measured: 60 days
Quality of sleep (assessed by VAS)
Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles)
Measured: 90 days
Quality of sleep (assessed by VAS)
Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles)
Measured: 180 days
Sleep time
Evaluation of the duration of sleep by parents
Measured: 30 days
Sleep time
Evaluation of the duration of sleep by parents
Measured: 60 days
Sleep time
Evaluation of the duration of sleep by parents
Measured: 90 days
Sleep time
Evaluation of the duration of sleep by parents
Measured: 180 days
IDQoL (Infant's Dermatitis Quality of Life)
Evaluation of the infant's quality of life through the IDQoL (Infant's Dermatitis Quality of Life)
Measured: 90 days
Use of topical dermocorticoids
The quantity and class of dermocorticoids used will be evaluated
Measured: 30 days
Use of topical dermocorticoids
The quantity and class of dermocorticoids used will be evaluated
Measured: 60 days
Use of topical dermocorticoids
The quantity and class of dermocorticoids used will be evaluated
Measured: 90 days
Use of topical dermocorticoids
The quantity and class of dermocorticoids used will be evaluated
Measured: 180 days
Atopic dermatitis flare
The number of flare will be evaluated
Measured: 30 days
Atopic dermatitis flare
The number of flare will be evaluated
Measured: 60 days
Atopic dermatitis flare
The number of flare will be evaluated
Measured: 90 days
Atopic dermatitis flare
The number of flare will be evaluated
Measured: 180 days
Weight
Weight evolution
Measured: 30 days
Weight
Weight evolution
Measured: 60 days
Weight
Weight evolution
Measured: 90 days
Weight
Weight evolution
Measured: 180 days
Length/Height
Length/Height evolution
Measured: 30 days
Length/Height
Length/Height evolution
Measured: 60 days
Length/Height
Length/Height evolution
Measured: 90 days
Length/Height
Length/Height evolution
Measured: 180 days
Regurgitations
Evolution of the daily number of regurgitations
Measured: Day 30
Regurgitations
Evolution of the daily number of regurgitations
Measured: Day 60
Regurgitations
Evolution of the daily number of regurgitations
Measured: Day 90
Regurgitations
Evolution of the daily number of regurgitations
Measured: Day 180
Stool's frequency
Evolution of the number of stools per day through a qualitative scale
Measured: Day 30
Stool's frequency
Evolution of the number of stools per day through a qualitative scale
Measured: Day 60
Stool's frequency
Evolution of the number of stools per day through a qualitative scale
Measured: Day 90
Stool's frequency
Evolution of the number of stools per day through a qualitative scale
Measured: Day 180
Stool's consistency
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Measured: Day 30
Stool's consistency
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Measured: Day 60
Stool's consistency
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Measured: Day 90
Stool's consistency
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Measured: Day 180
Gas, bloating
Evolution of presence/absence of gas, bloating
Measured: Day 30
Gas, bloating
Evolution of presence/absence of gas, bloating
Measured: Day 60
Gas, bloating
Evolution of presence/absence of gas, bloating
Measured: Day 90
Gas, bloating
Evolution of presence/absence of gas, bloating
Measured: Day 180
Satisfaction of the parents
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Measured: Day 30
Satisfaction of the parents
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Measured: Day 60
Satisfaction of the parents
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Measured: Day 90
Satisfaction of the parents
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Measured: Day 180
Satisfaction of the investigator
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Measured: Day 30
Satisfaction of the investigator
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Measured: Day 60
Satisfaction of the investigator
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Measured: Day 90
Satisfaction of the investigator
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start24 May 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabienne Cahn-Sellem, Principal investigator, Private PracticeSebastien Barbarot, Study chair, Hotel Dieu Hospital, Nantes, FranceElena Bradatan, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318300
- Sponsor's protocol ID
- UP2018-EFITOP
- Status last verified
- Dec 2023
- First submitted
- 18 Mar 2022
- Last updated
- 8 Dec 2023
- 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 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Cow's Milk Protein-based Formulas for Infants in the Management of Moderate to Severe aTOPic Dermatitis in Infants Aged Less Than 18 Months
- ClinicalTrials.gov ID
- NCT05318300
- Acronym / sponsor ID
- UP2018-EFITOP
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- United PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 May 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 8 Apr 2022 (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.
The aim of this study is to show the efficiency of a new infant formula containing fiber on the management of moderate to severe atopic dermatitis.
Detailed description
The study is double blind randomized where the new formula is compared to a placebo during 3 months followed by a period of 3 months optional. During this period of time, all infant include in the study will be fed with the study formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tested formula LP-2018 | Experimental | Dietary Supplement: tested formula with fiberinfant formula containing fibers |
| Placebo formula CT-2018 | Placebo comparator | Dietary Supplement: Controlinfant formula without fibers |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged below 18 month
- Having an atopic dermatitis diagnosed according to the United Kingdom Working Party - Having an Eczema Area Severity Index (EASI) between 7.1 and 50.0
- Whose parents gave their informed consent
Key exclusion criteria (9 listed)
- systemic corticotherapy
- antihistamine
- use of dermocorticoide and/or antibiotics within 15 days
- symptoms of cutaneous infection
- Past anaphylactic shock
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 |
|---|---|---|
| tested formula with fiberformula containing fibers | Dietary supplement | Tested formula LP-2018 |
| Controlformula without fiber | Dietary supplement | Placebo formula CT-2018 |
Primary outcome
EASI (Eczema Area Severity Index) score after 90 days.
Time frame: 90 days
evolution of the EASI score between day 0 to day 90. The score range is between 0 (no eczema) and 72 (highest score of eczema)
64 secondary outcomes
EASI (Eczema Area Severity Index) score after 30 days.
Time frame: 30 days
EASI (Eczema Area Severity Index) score after 60 days.
Time frame: 60 days
EASI (Eczema Area Severity Index) score after 180 days.
Time frame: 180 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Time frame: 30 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Time frame: 60 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Time frame: 90 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Time frame: 180 days
Skin dryness
Time frame: 30 days
Skin dryness
Time frame: 60 days
Skin dryness
Time frame: 90 days
Skin dryness
Time frame: 180 days
Itching
Time frame: 30 days
Itching
Time frame: 60 days
Itching
Time frame: 90 days
Itching
Time frame: 180 days
Quality of sleep (assessed by VAS)
Time frame: 30 days
Quality of sleep (assessed by VAS)
Time frame: 60 days
Quality of sleep (assessed by VAS)
Time frame: 90 days
Quality of sleep (assessed by VAS)
Time frame: 180 days
Sleep time
Time frame: 30 days
Sleep time
Time frame: 60 days
Sleep time
Time frame: 90 days
Sleep time
Time frame: 180 days
IDQoL (Infant's Dermatitis Quality of Life)
Time frame: 90 days
Use of topical dermocorticoids
Time frame: 30 days
Use of topical dermocorticoids
Time frame: 60 days
Use of topical dermocorticoids
Time frame: 90 days
Use of topical dermocorticoids
Time frame: 180 days
Atopic dermatitis flare
Time frame: 30 days
Atopic dermatitis flare
Time frame: 60 days
Atopic dermatitis flare
Time frame: 90 days
Atopic dermatitis flare
Time frame: 180 days
Weight
Time frame: 30 days
Weight
Time frame: 60 days
Weight
Time frame: 90 days
Weight
Time frame: 180 days
Length/Height
Time frame: 30 days
Length/Height
Time frame: 60 days
Length/Height
Time frame: 90 days
Length/Height
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- 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.
Fabienne Cahn-Sellem principal investigator
Private Practice
Sebastien Barbarot study chair
Hotel Dieu Hospital, Nantes, France
Elena Bradatan principal investigator
Private Practice
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tested formula with fiber in people with Atopic Dermatitis, run by United Pharmaceuticals at 3 sites in 2 countries.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, France. 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. Some participants in this study may receive a placebo. 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?
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?
EASI (Eczema Area Severity Index) score after 90 days. (time frame: 90 days). 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 Dec 2023.