Atopic DermatitisNCT05530707
Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer
A study testing Moisturizer containing saccharide isomerate and niacinamide in people with Atopic Dermatitis, run by Farmoquimica S.A. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Moisturizer containing saccharide isomerate and niacinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Sep 2022to 19 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Moisturizer containing saccharide isomerate and niacinamide
- Keywords
- cosmetics
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisturizer containing saccharide isomerate and niacinamideOther
Moisturizer containing saccharide isomerate and niacinamide
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Moisturizer containing saccharide isomerate and niacinamide |
| Clinical Trial | Experimental | 36 participants using the product for 60 days. Aims to evaluate the clinical, subjective and instrumental usage. Receives: Other: Moisturizer containing saccharide isomerate and niacinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Change from Baseline (Day 0) and day 30
Secondary outcomes (6)
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
Measured: 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®
Measured: 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®
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0, 7, 30 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start5 Sep 2022
- Primary completion19 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farmoquimica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medcin Instituto da Pele
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530707
- Sponsor's protocol ID
- EN21-0556-01_EN22-2004-01
- Status last verified
- Jan 2023
- First submitted
- 11 Aug 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05530707
- Acronym / sponsor ID
- EN21-0556-01_EN22-2004-01
- Conditions
- Atopic Dermatitis
- Keywords
- cosmetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Farmoquimica S.A.Industry (pharma, biotech, devices)
- Collaborators
- Medcin Instituto da Pele
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microbiome | Experimental | Other: Moisturizer containing saccharide isomerate and niacinamide13 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 | Other: Moisturizer containing saccharide isomerate and niacinamide36 participants using the product for 60 days. Aims to evaluate the clinical, subjective and instrumental usage. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moisturizer containing saccharide isomerate and niacinamideMoisturizer containing saccharide isomerate and niacinamide | Other | Clinical Trial, Microbiome |
Primary outcome
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.
6 secondary outcomes
Clinical Evaluation through dermatological questionnaire
Time frame: Day 60
Increase of skin hidration using instrumental evaluation - Corneometer
Time frame: Day 0, 7, 30 and 60
Evaluation of recovery of skin barrier through instrumental method - TEWL
Time frame: Day 7, 30 and 60
Strengthening of the skin barrier
Time frame: Day 0, 30 and 60
Subjective efficacy from the participants
Time frame: Day 0, 7, 30 and 60
Improvement of Quality of Life
Time frame: Day 0, 7, 30 and 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moisturizer containing saccharide isomerate and niacinamide in people with Atopic Dermatitis, run by Farmoquimica S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability in real conditions of use by questionnaire (time frame: Day 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.