NCT05530707

Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer

Avaliação de Aceitabilidade dérmica, eficácia Hidratante, restauração da Barreira e equilíbrio da Microbiota da Pele atópica de um Produto Hidratante - Estudo Clínico, Instrumental e Subjetivo.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Farmoquimica S.A. · Industry
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Accepted

Summary

A unicentric, blind, non-comparative clinical study to evaluate the efficacy of a moisturizer in reducing clinical symptons of atopic dermatites in children through clinical, subjective and instrumental evaluations.

Detailed description

A unicentric, blind, non-comparative clinical study to evaluate the efficacy of a moisturizer in reducing clinical symptons of atopic skin dermatites in children through clinical, subjective and instrumental evaluations. Participants will be divided into 2 groups - (Group 1) Microbiome analysis; and (Group 2) Acceptabily and efficacy Group 1: It will be necessary 13 participants aged between 05 and 12 years old with historical of atopia The participant will remain in the study for 30 days using the product. Visits will be scheduled in D0 and D30. On both visits, samples will be collect to quantify Staphylococcus aureus using qPCR Group 2: It will be necessary 36 participants aged between 05 and 12 years old with historical of atopia The participant will remain in the study for 60 days using the product. Visits will be scheduled in D0, D7, D30 and D60. Instrumental evaluations: It will be evaluate on each visit: Skin hidration using Corneometer - D0, D7, D30, D60 Transepidermic water loss using TEWL - D0, D7, D30, D60 Skin barrier restoration using Confocal Microscopy - D0, D30, D60 Participants will respond to a subjective assessment using a questionnaire to capture possible feelings of discomfort during the study e subjective efficiency. A dermatologist will be available to monitor the participants throughout the study and respond a assessment of clinical efficiency.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
OTHER	Moisturizer containing saccharide isomerate and niacinamide	Moisturizer containing saccharide isomerate and niacinamide

Timeline

• Start date: 2022-09-05
• Primary completion: 2023-01-19
• Completion: 2023-01-19
• First posted: 2022-09-07
• Last updated: 2023-01-20

Locations

1 site across 1 country: Brazil