Status:
UNKNOWN
Evaluation of an Adapted Formula on Atopic Dermatitis.
Lead Sponsor:
United Pharmaceuticals
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
1-18 years
Phase:
NA
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05318300
Start Date
May 24 2022
End Date
April 1 2024
Last Update
December 8 2023
Active Locations (3)
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1
Center_13
Namur, Belgium
2
Center_14
Thuin, Belgium
3
Center_05
Nice, France