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Evaluation of an Adapted Formula on Atopic Dermatitis.

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tested formula with fiber
Control
Sponsored by
United Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

1 Month - 18 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center_05Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tested formula LP-2018

Placebo formula CT-2018

Arm Description

infant formula containing fibers

infant formula without fibers

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2022
Last Updated
July 18, 2022
Sponsor
United Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05318300
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tested formula LP-2018
Arm Type
Experimental
Arm Description
infant formula containing fibers
Arm Title
Placebo formula CT-2018
Arm Type
Placebo Comparator
Arm Description
infant formula without fibers
Intervention Type
Dietary Supplement
Intervention Name(s)
tested formula with fiber
Intervention Description
formula containing fibers
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
formula without fiber
Primary Outcome Measure Information:
Title
EASI (Eczema Area Severity Index) score after 90 days.
Description
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)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
EASI (Eczema Area Severity Index) score after 30 days.
Description
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)
Time Frame
30 days
Title
EASI (Eczema Area Severity Index) score after 60 days.
Description
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)
Time Frame
60 days
Title
EASI (Eczema Area Severity Index) score after 180 days.
Description
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)
Time Frame
180 days
Title
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Description
Area under the curve of PO SCORAD
Time Frame
30 days
Title
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Description
Area under the curve of PO SCORAD
Time Frame
60 days
Title
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Description
Area under the curve of PO SCORAD
Time Frame
90 days
Title
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Description
Area under the curve of PO SCORAD
Time Frame
180 days
Title
Skin dryness
Description
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Time Frame
30 days
Title
Skin dryness
Description
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Time Frame
60 days
Title
Skin dryness
Description
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Time Frame
90 days
Title
Skin dryness
Description
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Time Frame
180 days
Title
Itching
Description
Evolution of itching evaluated by the investigator using an analogic visual scale
Time Frame
30 days
Title
Itching
Description
Evolution of itching evaluated by the investigator using an analogic visual scale
Time Frame
60 days
Title
Itching
Description
Evolution of itching evaluated by the investigator using an analogic visual scale
Time Frame
90 days
Title
Itching
Description
Evolution of itching evaluated by the investigator using an analogic visual scale
Time Frame
180 days
Title
Quality of sleep (assessed by VAS)
Description
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)
Time Frame
30 days
Title
Quality of sleep (assessed by VAS)
Description
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)
Time Frame
60 days
Title
Quality of sleep (assessed by VAS)
Description
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)
Time Frame
90 days
Title
Quality of sleep (assessed by VAS)
Description
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)
Time Frame
180 days
Title
Sleep time
Description
Evaluation of the duration of sleep by parents
Time Frame
30 days
Title
Sleep time
Description
Evaluation of the duration of sleep by parents
Time Frame
60 days
Title
Sleep time
Description
Evaluation of the duration of sleep by parents
Time Frame
90 days
Title
Sleep time
Description
Evaluation of the duration of sleep by parents
Time Frame
180 days
Title
IDQoL (Infant's Dermatitis Quality of Life)
Description
Evaluation of the infant's quality of life through the IDQoL (Infant's Dermatitis Quality of Life)
Time Frame
90 days
Title
Use of topical dermocorticoids
Description
The quantity and class of dermocorticoids used will be evaluated
Time Frame
30 days
Title
Use of topical dermocorticoids
Description
The quantity and class of dermocorticoids used will be evaluated
Time Frame
60 days
Title
Use of topical dermocorticoids
Description
The quantity and class of dermocorticoids used will be evaluated
Time Frame
90 days
Title
Use of topical dermocorticoids
Description
The quantity and class of dermocorticoids used will be evaluated
Time Frame
180 days
Title
Atopic dermatitis flare
Description
The number of flare will be evaluated
Time Frame
30 days
Title
Atopic dermatitis flare
Description
The number of flare will be evaluated
Time Frame
60 days
Title
Atopic dermatitis flare
Description
The number of flare will be evaluated
Time Frame
90 days
Title
Atopic dermatitis flare
Description
The number of flare will be evaluated
Time Frame
180 days
Title
Weight
Description
Weight evolution
Time Frame
30 days
Title
Weight
Description
Weight evolution
Time Frame
60 days
Title
Weight
Description
Weight evolution
Time Frame
90 days
Title
Weight
Description
Weight evolution
Time Frame
180 days
Title
Length/Height
Description
Length/Height evolution
Time Frame
30 days
Title
Length/Height
Description
Length/Height evolution
Time Frame
60 days
Title
Length/Height
Description
Length/Height evolution
Time Frame
90 days
Title
Length/Height
Description
Length/Height evolution
Time Frame
180 days
Title
Regurgitations
Description
Evolution of the daily number of regurgitations
Time Frame
Day 30
Title
Regurgitations
Description
Evolution of the daily number of regurgitations
Time Frame
Day 60
Title
Regurgitations
Description
Evolution of the daily number of regurgitations
Time Frame
Day 90
Title
Regurgitations
Description
Evolution of the daily number of regurgitations
Time Frame
Day 180
Title
Stool's frequency
Description
Evolution of the number of stools per day through a qualitative scale
Time Frame
Day 30
Title
Stool's frequency
Description
Evolution of the number of stools per day through a qualitative scale
Time Frame
Day 60
Title
Stool's frequency
Description
Evolution of the number of stools per day through a qualitative scale
Time Frame
Day 90
Title
Stool's frequency
Description
Evolution of the number of stools per day through a qualitative scale
Time Frame
Day 180
Title
Stool's consistency
Description
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Time Frame
Day 30
Title
Stool's consistency
Description
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Time Frame
Day 60
Title
Stool's consistency
Description
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Time Frame
Day 90
Title
Stool's consistency
Description
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Time Frame
Day 180
Title
Gas, bloating
Description
Evolution of presence/absence of gas, bloating
Time Frame
Day 30
Title
Gas, bloating
Description
Evolution of presence/absence of gas, bloating
Time Frame
Day 60
Title
Gas, bloating
Description
Evolution of presence/absence of gas, bloating
Time Frame
Day 90
Title
Gas, bloating
Description
Evolution of presence/absence of gas, bloating
Time Frame
Day 180
Title
Satisfaction of the parents
Description
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time Frame
Day 30
Title
Satisfaction of the parents
Description
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time Frame
Day 60
Title
Satisfaction of the parents
Description
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time Frame
Day 90
Title
Satisfaction of the parents
Description
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time Frame
Day 180
Title
Satisfaction of the investigator
Description
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time Frame
Day 30
Title
Satisfaction of the investigator
Description
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time Frame
Day 60
Title
Satisfaction of the investigator
Description
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time Frame
Day 90
Title
Satisfaction of the investigator
Description
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time Frame
Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Sophie GARREAU
Phone
003315572222
Email
as.garreau@novalac.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabienne Cahn-Sellem
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sebastien Barbarot
Organizational Affiliation
Hotel Dieu Hospital, Nantes, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elena Bradatan
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center_05
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of an Adapted Formula on Atopic Dermatitis.

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