NCT06108570Completed
Evaluation of the Efficacy of TOPIALYSE Baume Protect+ on Atopic Dermatis
Evaluation of the Efficacy and Tolerance of TOPIALYSE Baume Protect+ Vs Neutral Product on Patients Suffering from Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 5 Dec 2024
Brief summary (registry, in English)
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 are added to this circle. There is a lot of talk about pollution but, more recently, studies have been carried out on the worsening role of dust mites on atopic skin. TOPIALYSE Baume Protect+ is a care product that is lipid-replenishing, repairing and protective: a triple reinforced action for 48 hours: anti-scratching, anti-irritation, and external anti-aggression. It is also intended for the whole family from birth for dry skin with an atopic tendency (with atopic eczema). The main objective of this study is to evaluate the efficacy of the cosmetic product SVR TOPIALYSE Baume Protect+ versus Neutral Product on patients with mild atopic dermatitis, after 4 weeks of use with evaluation of the evolution mEASI (modified Eczema Area and Severity Index)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 25 Oct 2023
- Start date
- 15 Dec 2023
- Primary completion date
- 19 Jul 2024
- Lead sponsor
- SVR Group
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06108570
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 15 Dec 2023 to the primary completion date, 19 Jul 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Volunteer participating in another study or being in an exclusion period from a previous study.
Other illness
- Volunteer with a history of allergy or hypersensitivity reaction to a cosmetic or any of the constituents of the test products.
- Presence of dermatosis, skin pathology or systemic disease that, in the opinion of the investigator, may interfere with the evaluation of the study parameters.
Other
- Existence of a systemic or local treatment which, in the opinion of the investigator, may interfere with the evaluation of the parameters studied.
Who the study is looking for
- 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
Age in the registry: 3 months to 18 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Hòpital Universitaire des Enfants Reine Fabiola Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.