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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Moisturizer containing saccharide isomerate and niacinamide
Sponsored by
Farmoquimica S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atopic Dermatitis focused on measuring cosmetics

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Medcin Instituto da Pele

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Microbiome

Clinical Trial

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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
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®
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®
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
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
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

Full Information

First Posted
August 11, 2022
Last Updated
January 19, 2023
Sponsor
Farmoquimica S.A.
Collaborators
Medcin Instituto da Pele
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1. Study Identification

Unique Protocol Identification Number
NCT05530707
Brief Title
Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
January 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Farmoquimica S.A.
Collaborators
Medcin Instituto da Pele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
cosmetics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microbiome
Arm Type
Experimental
Arm Description
13 participants using the product for 30 days. Aims to evaluate the quantification of S. Aureus in the skin before and after usage.
Arm Title
Clinical Trial
Arm Type
Experimental
Arm Description
36 participants using the product for 60 days. Aims to evaluate the clinical, subjective and instrumental usage.
Intervention Type
Other
Intervention Name(s)
Moisturizer containing saccharide isomerate and niacinamide
Intervention Description
Moisturizer containing saccharide isomerate and niacinamide
Primary Outcome Measure Information:
Title
Acceptability in real conditions of use by questionnaire
Description
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).
Time Frame
Day 60
Title
Change of qPCR quantification of Staphylococcus aureus
Description
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.
Time Frame
Change from Baseline (Day 0) and day 30
Secondary Outcome Measure Information:
Title
Clinical Evaluation through dermatological questionnaire
Description
Evaluate the efficacy in reducing the signs of atopic dermatitis through dermatological clinical evaluation after 60 days of continuous use of the product
Time Frame
Day 60
Title
Increase of skin hidration using instrumental evaluation - Corneometer
Description
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®
Time Frame
Day 0, 7, 30 and 60
Title
Evaluation of recovery of skin barrier through instrumental method - TEWL
Description
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®
Time Frame
Day 7, 30 and 60
Title
Strengthening of the skin barrier
Description
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
Time Frame
Day 0, 30 and 60
Title
Subjective efficacy from the participants
Description
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
Time Frame
Day 0, 7, 30 and 60
Title
Improvement of Quality of Life
Description
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
Time Frame
Day 0, 7, 30 and 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Medcin Instituto da Pele
City
Osasco
State/Province
São Paulo
ZIP/Postal Code
06023-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
D60

Learn more about this trial

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

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