Clinical trial NCT05318300: Evaluation of an Adapted Formula on Atopic Dermatitis.
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-04-08
Enrollment: 126
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Exclusive or predominant breast feediing (more than one feeding/day)
* Consumption of less than 500 ml per day
* Participation to another trial.

Primary outcomes:
measure: EASI (Eczema Area Severity Index) score after 90 days.
timeFrame: 90 days
Secondary outcomes:
measure: EASI (Eczema Area Severity Index) score after 30 days.
timeFrame: 30 days
measure: EASI (Eczema Area Severity Index) score after 60 days.
timeFrame: 60 days
measure: EASI (Eczema Area Severity Index) score after 180 days.
timeFrame: 180 days
measure: PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
timeFrame: 30 days
measure: PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
timeFrame: 60 days
measure: PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
timeFrame: 90 days
measure: PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
timeFrame: 180 days
measure: Skin dryness
timeFrame: 30 days
measure: Skin dryness
timeFrame: 60 days
measure: Skin dryness
timeFrame: 90 days
measure: Skin dryness
timeFrame: 180 days
measure: Itching
timeFrame: 30 days
measure: Itching
timeFrame: 60 days
measure: Itching
timeFrame: 90 days
measure: Itching
timeFrame: 180 days
measure: Quality of sleep (assessed by VAS)
timeFrame: 30 days
measure: Quality of sleep (assessed by VAS)
timeFrame: 60 days
measure: Quality of sleep (assessed by VAS)
timeFrame: 90 days
measure: Quality of sleep (assessed by VAS)
timeFrame: 180 days
measure: Sleep time
timeFrame: 30 days
measure: Sleep time
timeFrame: 60 days
measure: Sleep time
timeFrame: 90 days
measure: Sleep time
timeFrame: 180 days
measure: IDQoL (Infant's Dermatitis Quality of Life)
timeFrame: 90 days
measure: Use of topical dermocorticoids
timeFrame: 30 days
measure: Use of topical dermocorticoids
timeFrame: 60 days
measure: Use of topical dermocorticoids
timeFrame: 90 days
measure: Use of topical dermocorticoids
timeFrame: 180 days
measure: Atopic dermatitis flare
timeFrame: 30 days
measure: Atopic dermatitis flare
timeFrame: 60 days
measure: Atopic dermatitis flare
timeFrame: 90 days
measure: Atopic dermatitis flare
timeFrame: 180 days
measure: Weight
timeFrame: 30 days
measure: Weight
timeFrame: 60 days
measure: Weight
timeFrame: 90 days
measure: Weight
timeFrame: 180 days
measure: Length/Height
timeFrame: 30 days
measure: Length/Height
timeFrame: 60 days
measure: Length/Height
timeFrame: 90 days
measure: Length/Height
timeFrame: 180 days
measure: Regurgitations
timeFrame: Day 30
measure: Regurgitations
timeFrame: Day 60
measure: Regurgitations
timeFrame: Day 90
measure: Regurgitations
timeFrame: Day 180
measure: Stool's frequency
timeFrame: Day 30
measure: Stool's frequency
timeFrame: Day 60
measure: Stool's frequency
timeFrame: Day 90
measure: Stool's frequency
timeFrame: Day 180
measure: Stool's consistency
timeFrame: Day 30
measure: Stool's consistency
timeFrame: Day 60
measure: Stool's consistency
timeFrame: Day 90
measure: Stool's consistency
timeFrame: Day 180
measure: Gas, bloating
timeFrame: Day 30
measure: Gas, bloating
timeFrame: Day 60
measure: Gas, bloating
timeFrame: Day 90
measure: Gas, bloating
timeFrame: Day 180
measure: Satisfaction of the parents
timeFrame: Day 30
measure: Satisfaction of the parents
timeFrame: Day 60
measure: Satisfaction of the parents
timeFrame: Day 90
measure: Satisfaction of the parents
timeFrame: Day 180
measure: Satisfaction of the investigator
timeFrame: Day 30
measure: Satisfaction of the investigator
timeFrame: Day 60
measure: Satisfaction of the investigator
timeFrame: Day 90
measure: Satisfaction of the investigator
timeFrame: Day 180
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Center_13
city: Thuin
country: Belgium
facility: Center_14
city: Nice
country: France
facility: Center_05
Study officials:
affiliation: Private Practice
name: Fabienne Cahn-Sellem
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu Hospital, Nantes, France
name: Sebastien Barbarot
role: STUDY_CHAIR
affiliation: Private Practice
name: Elena Bradatan
role: PRINCIPAL_INVESTIGATOR
References: