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| Name | Class |
|---|---|
| Medcin Instituto da Pele | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Clinical Trial | Experimental | 36 participants using the product for 60 days. Aims to evaluate the clinical, subjective and instrumental usage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moisturizer containing saccharide isomerate and niacinamide | Other | Moisturizer containing saccharide isomerate and niacinamide |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medcin Instituto da Pele | Osasco | São Paulo | 06023-000 | Brazil |
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D60
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |