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.

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Moisturizer containing saccharide isomerate and niacinamide

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Osasco, São Paulo, Brazil, 06023-000
      • Medcin Instituto Da Pele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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);
2. 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
3. Participants with a history of atopy
4. Participants with presence of dry skin with dryness, flaking and mild itching in the pretibial region
5. 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

Exclusion Criteria:

1. Pregnancy/lactation or intention to become pregnant during the study period;
2. Presence of active lesions of atopic dermatitis for group 2 of participants - Clinical study;
3. 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;
4. 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;
5. Participants currently presenting a skin infection requiring treatment or are currently in need of treatment with topical or systemic antibiotics;
6. 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);
7. Unable or unwilling to be available throughout the study and/or not be willing to follow the study restrictions/procedures;
8. Stomach diseases such as gastritis and ulcers;
9. Chronic use of corticosteroids (systemic or topical);
10. Chronic kidney diseases, chronic liver diseases;
11. Clinical evidence of immunosuppression;
12. Allergic history of category products;
13. Participants with known congenital or acquired immunodeficiency;
14. Relevant clinical history or current evidence of alcohol or other drug abuse;
15. known history or suspected intolerance of products of the same category;
16. Intense sun exposure up to 30 days before evaluation;
17. Professionals directly involved in the present study;
18. Other conditions considered by the evaluating physician as reasonable for disqualification from the participation of the study. If yes, it should be described under observation in the clinical file.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microbiome; 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; Moisturizer containing saccharide isomerate and niacinamide
Experimental: Clinical Trial; 36 participants using the product for 60 days. Aims to evaluate the clinical, subjective and instrumental usage.	Other: Moisturizer containing saccharide isomerate and niacinamide; Moisturizer containing saccharide isomerate and niacinamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Evaluation through dermatological questionnaire	Evaluate the efficacy in reducing the signs of atopic dermatitis through dermatological clinical evaluation after 60 days of continuous use of the product	Day 60
Increase of skin hidration using instrumental evaluation - Corneometer	Evaluate the moisturizing efficacy immediately (D0) after application of the investigational product and after 7 (D7), 30 (D30) and 60 (D60) days of continuous use, through the Corneometer equipment®	Day 0, 7, 30 and 60
Evaluation of recovery of skin barrier through instrumental method - TEWL	Evaluate the efficacy in the recovery of the skin barrier after 7 (D7), 30 (D30) and 60 (D60) days of continuous use of the product through the Tewameter equipment®	Day 7, 30 and 60
Strengthening of the skin barrier	Evaluate the strengthening of the skin barrier in D0 and after 30 (D30) and 60 (D60) days of continuous use of the product by confocal reflectance microscopy	Day 0, 30 and 60
Subjective efficacy from the participants	Evaluate the perceived efficacy of the product from the participant's point of view through a subjective questionnaire immediately after the first application (Timed) and after 7 (D7), 30 (D30) and 60 (D60) days of continuous use of the product	Day 0, 7, 30 and 60
Improvement of Quality of Life	Evaluate the improvement of the quality of life of the atopic dermatitis carrier through a questionnaire on quality of life in D0 and after 30 and 60 days of continuous use of the product	Day 0, 7, 30 and 60

Collaborators and Investigators

• Sponsor: Farmoquimica S.A.
• Collaborators: Medcin Instituto da Pele

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): January 19, 2023

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: cosmetics
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: EN21-0556-01_EN22-2004-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: D60
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No