Evaluation of the Efficacy of TOPIALYSE Baume Protect+ on Atopic Dermatis

NCT06108570 | Completed

• 2 other identifiers: TOPIAbis-2022B4032023000074
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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 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)

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Evaluation of the evolution of the symptoms associated with mild atopic dermatitis by the mEASI score

  At D0 and D28±3, the dermatologist calculates the mEASI (modified Eczema Area and Severity Index) over the entire body, for that he have to select the affected area ( head and neck, upper extremities, trunk, lower extremities). For each zone, the investigator assesses the severity of the 4 signs of atopic dermatitis (erythema, oedema/papulation, excoriation, lichenification) from 0 ( none) to 3 (severe) on the selected area, he assesse the extent of atopic dermatitis in that area from 0 (none) to 6 (100% area of the body).

  DAY 0 and DAY 28±3

Secondary Outcomes (5)

• Evaluation of the tolerance of TOPIALYSE Baume Protect+ versus Neutral Product.

  DAY 28±3

• Evaluation of children's quality of life by IDQOL

  DAY 0 and DAY 28±3

• Evaluation of pruritus by VAS

  DAY 0 and DAY 28±3

• Analysis of the subject's answers to a subjective product evaluation questionnaire

  DAY 0 and DAY 28±3

• General safety: General Adverse Events will be reported descriptively on an on-going basis

  DAY 0 and DAY 28±3

Study Arms (1)

Study methodology

OTHER

This is an intra-individual comparison study.

Other: Cosmetic Product TOPIALYSE Baume Protect+

Interventions

Cosmetic Product TOPIALYSE Baume Protect+ OTHER

One or two application.s of TOPIALYSE Baume Protect+ daily on one side for 28±3 days and the Neutral Product daily on the other side for 28±3 days. The side will be decided before by randomisation.

Also known as: Cosmetic product Neutral Product

Study methodology

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SVR Group: lead

Study Sites (3)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Hopital Universitaire Des Enfants Reine Fabiola

Brussels, Belgium

Location

Grand Hopital de Charleroi

Charleroi, Belgium

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The randomisation will be done on the side of the treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-individual comparison

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: December 15, 2023
• Primary Completion: July 19, 2024
• Study Completion: August 22, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)