Evaluation of an Adapted Formula on Atopic Dermatitis.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- EASI (Eczema Area Severity Index) score after 90 days. [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. [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. [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. [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 [30 days]
Area under the curve of PO SCORAD
- PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution [60 days]
Area under the curve of PO SCORAD
- PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution [90 days]
Area under the curve of PO SCORAD
- PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution [180 days]
Area under the curve of PO SCORAD
- Skin dryness [30 days]
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
- Skin dryness [60 days]
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
- Skin dryness [90 days]
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
- Skin dryness [180 days]
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
- Itching [30 days]
Evolution of itching evaluated by the investigator using an analogic visual scale
- Itching [60 days]
Evolution of itching evaluated by the investigator using an analogic visual scale
- Itching [90 days]
Evolution of itching evaluated by the investigator using an analogic visual scale
- Itching [180 days]
Evolution of itching evaluated by the investigator using an analogic visual scale
- Quality of sleep (assessed by VAS) [30 days]
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) [60 days]
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) [90 days]
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) [180 days]
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 [30 days]
Evaluation of the duration of sleep by parents
- Sleep time [60 days]
Evaluation of the duration of sleep by parents
- Sleep time [90 days]
Evaluation of the duration of sleep by parents
- Sleep time [180 days]
Evaluation of the duration of sleep by parents
- IDQoL (Infant's Dermatitis Quality of Life) [90 days]
Evaluation of the infant's quality of life through the IDQoL (Infant's Dermatitis Quality of Life)
- Use of topical dermocorticoids [30 days]
The quantity and class of dermocorticoids used will be evaluated
- Use of topical dermocorticoids [60 days]
The quantity and class of dermocorticoids used will be evaluated
- Use of topical dermocorticoids [90 days]
The quantity and class of dermocorticoids used will be evaluated
- Use of topical dermocorticoids [180 days]
The quantity and class of dermocorticoids used will be evaluated
- Atopic dermatitis flare [30 days]
The number of flare will be evaluated
- Atopic dermatitis flare [60 days]
The number of flare will be evaluated
- Atopic dermatitis flare [90 days]
The number of flare will be evaluated
- Atopic dermatitis flare [180 days]
The number of flare will be evaluated
- Weight [30 days]
Weight evolution
- Weight [60 days]
Weight evolution
- Weight [90 days]
Weight evolution
- Weight [180 days]
Weight evolution
- Length/Height [30 days]
Length/Height evolution
- Length/Height [60 days]
Length/Height evolution
- Length/Height [90 days]
Length/Height evolution
- Length/Height [180 days]
Length/Height evolution
- Regurgitations [Day 30]
Evolution of the daily number of regurgitations
- Regurgitations [Day 60]
Evolution of the daily number of regurgitations
- Regurgitations [Day 90]
Evolution of the daily number of regurgitations
- Regurgitations [Day 180]
Evolution of the daily number of regurgitations
- Stool's frequency [Day 30]
Evolution of the number of stools per day through a qualitative scale
- Stool's frequency [Day 60]
Evolution of the number of stools per day through a qualitative scale
- Stool's frequency [Day 90]
Evolution of the number of stools per day through a qualitative scale
- Stool's frequency [Day 180]
Evolution of the number of stools per day through a qualitative scale
- Stool's consistency [Day 30]
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
- Stool's consistency [Day 60]
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
- Stool's consistency [Day 90]
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
- Stool's consistency [Day 180]
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
- Gas, bloating [Day 30]
Evolution of presence/absence of gas, bloating
- Gas, bloating [Day 60]
Evolution of presence/absence of gas, bloating
- Gas, bloating [Day 90]
Evolution of presence/absence of gas, bloating
- Gas, bloating [Day 180]
Evolution of presence/absence of gas, bloating
- Satisfaction of the parents [Day 30]
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
- Satisfaction of the parents [Day 60]
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
- Satisfaction of the parents [Day 90]
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
- Satisfaction of the parents [Day 180]
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
- Satisfaction of the investigator [Day 30]
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
- Satisfaction of the investigator [Day 60]
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
- Satisfaction of the investigator [Day 90]
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
- Satisfaction of the investigator [Day 180]
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center_05 | Nice | France |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- UP2018-EFITOP