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NCT05318300 Clinical Trial

Evaluation of an Adapted Formula on Atopic Dermatitis.

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05318300
Other study ID # UP2018-EFITOP
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 24, 2022
Est. completion date April 2024

Study information
Verified date December 2023
Source United Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 126
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• tested formula with fiber
formula containing fibers
• Control
formula without fiber

Locations
Country Name City State
Belgium Center_13 Namur
Belgium Center_14 Thuin
France Center_05 Nice

Sponsors (1)
Lead Sponsor Collaborator
United Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution Area under the curve of PO SCORAD 30 days
Secondary PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution Area under the curve of PO SCORAD 60 days
Secondary PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution Area under the curve of PO SCORAD 90 days
Secondary PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution Area under the curve of PO SCORAD 180 days
Secondary Skin dryness Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD 30 days
Secondary Skin dryness Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD 60 days
Secondary Skin dryness Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD 90 days
Secondary Skin dryness Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD 180 days
Secondary Itching Evolution of itching evaluated by the investigator using an analogic visual scale 30 days
Secondary Itching Evolution of itching evaluated by the investigator using an analogic visual scale 60 days
Secondary Itching Evolution of itching evaluated by the investigator using an analogic visual scale 90 days
Secondary Itching Evolution of itching evaluated by the investigator using an analogic visual scale 180 days
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Sleep time Evaluation of the duration of sleep by parents 30 days
Secondary Sleep time Evaluation of the duration of sleep by parents 60 days
Secondary Sleep time Evaluation of the duration of sleep by parents 90 days
Secondary Sleep time Evaluation of the duration of sleep by parents 180 days
Secondary 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
Secondary Use of topical dermocorticoids The quantity and class of dermocorticoids used will be evaluated 30 days
Secondary Use of topical dermocorticoids The quantity and class of dermocorticoids used will be evaluated 60 days
Secondary Use of topical dermocorticoids The quantity and class of dermocorticoids used will be evaluated 90 days
Secondary Use of topical dermocorticoids The quantity and class of dermocorticoids used will be evaluated 180 days
Secondary Atopic dermatitis flare The number of flare will be evaluated 30 days
Secondary Atopic dermatitis flare The number of flare will be evaluated 60 days
Secondary Atopic dermatitis flare The number of flare will be evaluated 90 days
Secondary Atopic dermatitis flare The number of flare will be evaluated 180 days
Secondary Weight Weight evolution 30 days
Secondary Weight Weight evolution 60 days
Secondary Weight Weight evolution 90 days
Secondary Weight Weight evolution 180 days
Secondary Length/Height Length/Height evolution 30 days
Secondary Length/Height Length/Height evolution 60 days
Secondary Length/Height Length/Height evolution 90 days
Secondary Length/Height Length/Height evolution 180 days
Secondary Regurgitations Evolution of the daily number of regurgitations Day 30
Secondary Regurgitations Evolution of the daily number of regurgitations Day 60
Secondary Regurgitations Evolution of the daily number of regurgitations Day 90
Secondary Regurgitations Evolution of the daily number of regurgitations Day 180
Secondary Stool's frequency Evolution of the number of stools per day through a qualitative scale Day 30
Secondary Stool's frequency Evolution of the number of stools per day through a qualitative scale Day 60
Secondary Stool's frequency Evolution of the number of stools per day through a qualitative scale Day 90
Secondary Stool's frequency Evolution of the number of stools per day through a qualitative scale Day 180
Secondary Stool's consistency Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale Day 30
Secondary Stool's consistency Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale Day 60
Secondary Stool's consistency Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale Day 90
Secondary Stool's consistency Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale Day 180
Secondary Gas, bloating Evolution of presence/absence of gas, bloating Day 30
Secondary Gas, bloating Evolution of presence/absence of gas, bloating Day 60
Secondary Gas, bloating Evolution of presence/absence of gas, bloating Day 90
Secondary Gas, bloating Evolution of presence/absence of gas, bloating Day 180
Secondary Satisfaction of the parents Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas Day 30
Secondary Satisfaction of the parents Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas Day 60
Secondary Satisfaction of the parents Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas Day 90
Secondary Satisfaction of the parents Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas Day 180
Secondary Satisfaction of the investigator Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas Day 30
Secondary Satisfaction of the investigator Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas Day 60
Secondary Satisfaction of the investigator Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas Day 90
Secondary Satisfaction of the investigator Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas Day 180
See also
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Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
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Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
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Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2