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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Farmoquimica S.A.
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- Acceptability in real conditions of use by questionnaire
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Improvement of Quality of Life(Day 0, 7, 30 and 60)
- Clinical Evaluation through dermatological questionnaire(Day 60)
- Increase of skin hidration using instrumental evaluation - Corneometer(Day 0, 7, 30 and 60)
- Subjective efficacy from the participants(Day 0, 7, 30 and 60)