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

NCT05530707 | Completed

• 1 other identifier: EN21-0556-01_EN22-2004-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis

Keywords

cosmetics

Outcome Measures

Primary Outcomes (2)

• Acceptability in real conditions of use by questionnaire

  Confirm in real conditions of use, the absence of risk and irritation and capture feelings of discomfort in the population studied (0 meaning no risk).

  Day 60

• Change of qPCR quantification of Staphylococcus aureus

  Evaluate the change in the skin microbiota by quantification of qPCR of Staphylococcus aureus in the skin before (D0) and after 30 (D30) days of continuous use of the product.

  Change from Baseline (Day 0) and day 30

Secondary Outcomes (6)

• Clinical Evaluation through dermatological questionnaire

  Day 60

• Increase of skin hidration using instrumental evaluation - Corneometer

  Day 0, 7, 30 and 60

• Evaluation of recovery of skin barrier through instrumental method - TEWL

  Day 7, 30 and 60

• Strengthening of the skin barrier

  Day 0, 30 and 60

• Subjective efficacy from the participants

  Day 0, 7, 30 and 60

Study Arms (2)

Microbiome

EXPERIMENTAL

13 participants using the product for 30 days. Aims to evaluate the quantification of S. Aureus in the skin before and after usage.

Other: Moisturizer containing saccharide isomerate and niacinamide

Clinical Trial

EXPERIMENTAL

36 participants using the product for 60 days. Aims to evaluate the clinical, subjective and instrumental usage.

Other: Moisturizer containing saccharide isomerate and niacinamide

Interventions

Moisturizer containing saccharide isomerate and niacinamide OTHER

Moisturizer containing saccharide isomerate and niacinamide

Clinical Trial; Microbiome

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Understand and consent to participation in this clinical trial, manifested through the signatures of the Informed Consent (TCLE) by at least one of the minor's legal guardians, and signature of the Free and Informed Consent Term (TALE) by the minor, when applicable (≥07 years);
• Agreement to participate the procedures and requirements of the study and attend the Institute on the day(s) and time(s) determined for the assessments accompanied by the responsible
• Participants with a history of atopy
• Participants with presence of dry skin with dryness, flaking and mild itching in the pretibial region
• Presence of active lesions of atopic dermatitis in the cubital cavus region for group 1 of participants who did not need other topical treatments besides the moisturizer

You may not qualify if:

• Pregnancy/lactation or intention to become pregnant during the study period;
• Presence of active lesions of atopic dermatitis for group 2 of participants - Clinical study;
• Use of the following topical or systemic medications: immunosuppressants, antihistamines, anti-inflammatory drugs corticosteroids up to 30 days prior to selection. For immunosuppressants, the interval should be 3 months prior to selection;
• Presenting or having a history of other concomitant skin conditions (e.g., psoriasis or lupus erythemasus) that interferes with the evaluations of the effect of the investigational product of the study on AD;
• Participants currently presenting a skin infection requiring treatment or are currently in need of treatment with topical or systemic antibiotics;
• Any serious concomitant disease in which the need for the use of systemic corticosteroids is expected or which, otherwise interfere with study participation or require frequent active monitoring (e.g., asthma chronicunstable);
• Unable or unwilling to be available throughout the study and/or not be willing to follow the study restrictions/procedures;
• Stomach diseases such as gastritis and ulcers;
• Chronic use of corticosteroids (systemic or topical);
• Chronic kidney diseases, chronic liver diseases;
• Clinical evidence of immunosuppression;
• Allergic history of category products;
• Participants with known congenital or acquired immunodeficiency;
• Relevant clinical history or current evidence of alcohol or other drug abuse;
• known history or suspected intolerance of products of the same category;

Sponsors & Collaborators

• Farmoquimica S.A.: lead
• Medcin Instituto da Pele: collaborator

Study Sites (1)

Medcin Instituto da Pele

Osasco, São Paulo, 06023-000, Brazil

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Niacinamide

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

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: September 7, 2022
• Study Start: September 5, 2022
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: D60

Locations

BR (1)