Evaluation of an Adapted Formula on Atopic Dermatitis.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Dietary supplement: tested formula with fiber; Dietary supplement: Control

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 Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Sophie GARREAU; Phone Number: 003315572222; Email: as.garreau@novalac.com

Study Locations

• Belgium
  • Namur, Belgium
    • Center_13
  • Thuin, Belgium
    • Center_14
• France
  • Nice, France
    • Center_05

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tested formula LP-2018; infant formula containing fibers	Dietary supplement: tested formula with fiber; formula containing fibers
Placebo Comparator: Placebo formula CT-2018; infant formula without fibers	Dietary supplement: Control; formula without fiber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	180 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution	Area under the curve of PO SCORAD	30 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution	Area under the curve of PO SCORAD	60 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution	Area under the curve of PO SCORAD	90 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution	Area under the curve of PO SCORAD	180 days
Skin dryness	Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD	30 days
Skin dryness	Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD	60 days
Skin dryness	Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD	90 days
Skin dryness	Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD	180 days
Itching	Evolution of itching evaluated by the investigator using an analogic visual scale	30 days
Itching	Evolution of itching evaluated by the investigator using an analogic visual scale	60 days
Itching	Evolution of itching evaluated by the investigator using an analogic visual scale	90 days
Itching	Evolution of itching evaluated by the investigator using an analogic visual scale	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)	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)	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)	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)	180 days
Sleep time	Evaluation of the duration of sleep by parents	30 days
Sleep time	Evaluation of the duration of sleep by parents	60 days
Sleep time	Evaluation of the duration of sleep by parents	90 days
Sleep time	Evaluation of the duration of sleep by parents	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)	90 days
Use of topical dermocorticoids	The quantity and class of dermocorticoids used will be evaluated	30 days
Use of topical dermocorticoids	The quantity and class of dermocorticoids used will be evaluated	60 days
Use of topical dermocorticoids	The quantity and class of dermocorticoids used will be evaluated	90 days
Use of topical dermocorticoids	The quantity and class of dermocorticoids used will be evaluated	180 days
Atopic dermatitis flare	The number of flare will be evaluated	30 days
Atopic dermatitis flare	The number of flare will be evaluated	60 days
Atopic dermatitis flare	The number of flare will be evaluated	90 days
Atopic dermatitis flare	The number of flare will be evaluated	180 days
Weight	Weight evolution	30 days
Weight	Weight evolution	60 days
Weight	Weight evolution	90 days
Weight	Weight evolution	180 days
Length/Height	Length/Height evolution	30 days
Length/Height	Length/Height evolution	60 days
Length/Height	Length/Height evolution	90 days
Length/Height	Length/Height evolution	180 days
Regurgitations	Evolution of the daily number of regurgitations	Day 30
Regurgitations	Evolution of the daily number of regurgitations	Day 60
Regurgitations	Evolution of the daily number of regurgitations	Day 90
Regurgitations	Evolution of the daily number of regurgitations	Day 180
Stool's frequency	Evolution of the number of stools per day through a qualitative scale	Day 30
Stool's frequency	Evolution of the number of stools per day through a qualitative scale	Day 60
Stool's frequency	Evolution of the number of stools per day through a qualitative scale	Day 90
Stool's frequency	Evolution of the number of stools per day through a qualitative scale	Day 180
Stool's consistency	Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale	Day 30
Stool's consistency	Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale	Day 60
Stool's consistency	Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale	Day 90
Stool's consistency	Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale	Day 180
Gas, bloating	Evolution of presence/absence of gas, bloating	Day 30
Gas, bloating	Evolution of presence/absence of gas, bloating	Day 60
Gas, bloating	Evolution of presence/absence of gas, bloating	Day 90
Gas, bloating	Evolution of presence/absence of gas, bloating	Day 180
Satisfaction of the parents	Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas	Day 30
Satisfaction of the parents	Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas	Day 60
Satisfaction of the parents	Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas	Day 90
Satisfaction of the parents	Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas	Day 180
Satisfaction of the investigator	Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas	Day 30
Satisfaction of the investigator	Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas	Day 60
Satisfaction of the investigator	Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas	Day 90
Satisfaction of the investigator	Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas	Day 180

Collaborators and Investigators

• Sponsor: United Pharmaceuticals
• Investigators: Principal Investigator: Fabienne Cahn-Sellem, Private Practice; Study Chair: Sebastien Barbarot, Hotel Dieu Hospital, Nantes, France; Principal Investigator: Elena Bradatan, Private Practice

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: UP2018-EFITOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No