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

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ClinicalTrials.gov Identifier: NCT05530707

Recruitment Status : Completed

First Posted : September 7, 2022

Last Update Posted : January 20, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Medcin Instituto da Pele

Information provided by (Responsible Party):

Farmoquimica S.A.

Tracking Information

First Submitted Date ^ICMJE

August 11, 2022

First Posted Date ^ICMJE

September 7, 2022

Last Update Posted Date

January 20, 2023

Actual Study Start Date ^ICMJE

September 5, 2022

Actual Primary Completion Date

January 19, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Acceptability in real conditions of use by questionnaire [ Time Frame: Day 60 ]
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).
Change of qPCR quantification of Staphylococcus aureus [ Time Frame: Change from Baseline (Day 0) and day 30 ]
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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Clinical Evaluation through dermatological questionnaire [ Time Frame: Day 60 ]
Evaluate the efficacy in reducing the signs of atopic dermatitis through dermatological clinical evaluation after 60 days of continuous use of the product
Increase of skin hidration using instrumental evaluation - Corneometer [ Time Frame: Day 0, 7, 30 and 60 ]
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®
Evaluation of recovery of skin barrier through instrumental method - TEWL [ Time Frame: Day 7, 30 and 60 ]
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®
Strengthening of the skin barrier [ Time Frame: Day 0, 30 and 60 ]
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
Subjective efficacy from the participants [ Time Frame: Day 0, 7, 30 and 60 ]
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
Improvement of Quality of Life [ Time Frame: Day 0, 7, 30 and 60 ]
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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

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 ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Other: Moisturizer containing saccharide isomerate and niacinamide

Moisturizer containing saccharide isomerate and niacinamide

Study Arms ^ICMJE

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.

Intervention: Other: 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.

Intervention: Other: Moisturizer containing saccharide isomerate and niacinamide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

January 19, 2023

Actual Primary Completion Date

January 19, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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;
Intense sun exposure up to 30 days before evaluation;
Professionals directly involved in the present study;
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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

5 Years to 12 Years (Child)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Brazil

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05530707

Other Study ID Numbers ^ICMJE

EN21-0556-01_EN22-2004-01

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	Clinical Study Report (CSR)
Time Frame:	D60