Status:
COMPLETED
Evaluation of the Efficacy of TOPIALYSE Baume Protect+ on Atopic Dermatis
Lead Sponsor:
SVR Group
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy and tolerability of a SVR care product. As we know, atopic dermatitis is a vicious circle that must be broken, but certain aggravating factors ar...
Detailed Description
1\. RATIONALE : The purpose of this study is to evaluate the efficacy and tolerability of a SVR care product. As we know, atopic dermatitis is a vicious circle that must be broken, but certain aggrav...
Eligibility Criteria
Inclusion
- Volunteer aged between 3 months and 18 years
- Female or male volunteer
- Volunteer with an atopic background and localized and symmetrical right/left signs of mild atopic dermatitis on the face and/or body: On the whole body: 0.1 \< EASI \< 7 \[2\] or
- Localized - mEASI (cf. Appendix n°1):
- On the arms: 0.02 \< mEASI \< 1.4
- On the legs: 0.04 \< mEASI \< 2.8 (0.03 \< mEASI \< 2.1 for children under 8 years old)
- On the trunk: 0.03 \< mEASI \< 2.1
- On the head/neck: 0.01 \< mEASI \< 0.7 (0.02 \< mEASI \< 1.4 for children under 8 years old)
- Volunteer agreeing not to use any other skincare product on the face or body for the duration of the study, except for study products,
- Volunteer agreeing not to perform any corticosteroid or immunosuppressive treatment, per os or topical for the duration of the study,
- Volunteer whose parent(s) or legal guardian(s) have given written consent to participate in the study,
- Volunteer related to the social security of a parent or legal guardian in accordance with the French law on interventional research
Exclusion
- Volunteer with a history of allergy or hypersensitivity reaction to a cosmetic or any of the constituents of the test products.
- Volunteer who received topical corticosteroid or immunosuppressive treatments during the week prior to study entry and during the study.
- Volunteer who received oral corticosteroids during the month prior to study entry.
- Presence of dermatosis, skin pathology or systemic disease that, in the opinion of the investigator, may interfere with the evaluation of the study parameters.
- Existence of a systemic or local treatment which, in the opinion of the investigator, may interfere with the evaluation of the parameters studied.
- Volunteer participating in another study or being in an exclusion period from a previous study.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06108570
Start Date
December 15 2023
End Date
August 22 2024
Last Update
December 5 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Cliniques Universitaires Saint-Luc
Brussels, Belgium
2
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium
3
Grand Hopital de Charleroi
Charleroi, Belgium