Atopic DermatitisNCT05575882
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.
A study testing Skin hydration, Barrier function measurement and Potential of hydrogen measurement (pH) in people with Atopic Dermatitis and Eczema, Atopic, run by NAOS Argentina S.A. at 3 sites in 3 countries.
Trial summary
Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group. 5 visits: inclusion visit [day (D) 0] and 4 follow-up visits (D30, D60, D90, and D120). Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Atopic Dermatitis, Eczema, Atopic
- What is being tested?
- Skin hydration, Barrier function measurement and Potential of hydrogen measurement (pH)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 3 Nov 2022to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- General criteria:
- Healthy subject (except AD and other atopic diseases - allergic rhinitis, conjunctivitis, and asthma). The subject can keep its usual treatment (antihistamines, inhaled corticosteroids, and antileukotriene treatment) during the study if applicable. Written informed consent from the subject's parent(s)/legal representative(s) and children over 8 years old (specific Argentina) and over 12 years old (specific Singapore). Subject accepting to continue the normal conditions of hygiene and sunscreen (if applicable). Subject, parents/legal representative(s) willing to adhere to the study protocol and procedures.
- Specific criteria:
- Sex: male or female. Age: from 6 months to 15 years. Subject having on average one flare-up per month during the four months preceding the study, including the one observed on the inclusion visit D0. Subject having EASI value from 7.1 - 21 on D0 (moderate AD). Subject having one atopic eruption on the inclusion visit which the dermatologist will prescribe topical corticosteroids or calcineurin's inhibitors (pimecrolimus and/or tacrolimus).
Who cannot join
- Subject presenting cutaneous pathology in the studied zone other than AD (according to the investigator's appreciation, i.e., acne, psoriasis). Subject using systemic treatment, including oral steroids and oral immunosuppressants e.g., ciclosporin during the previous weeks liable to interfere with the assessment of the cutaneous tolerance of the study product or placebo (according to the investigator's appreciation). Subject using skin-moisturizing products from inclusion (D0) other than the study product or placebo. Subject who had systemic therapy with immune-suppressive drugs and antibiotics within the last 14 days before the beginning of the study Subject having serious illness that might require regular systemic medication (e.g., insulin-dependent diabetes, cancer) or conditions that exclude a participation or might influence the study evaluation. Subject with documented allergies to the study product or placebo ingredients. Subject enrolled in another clinical study during the study period. Parent(s)/legal representative(s) considered by the investigator to be likely not compliant to the protocol.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Argentina1 site, 1 recruiting
- Not yet recruiting
Cirec Latam
Ciudad Autónoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, 1426
Shantal Valdés, PhD, 005491123465946, Shantal.Valdes@ar.naos.com
Alejandra Piegari, MD, 005491164964851, alepiegari@gmail.com
India1 site, 1 recruiting
- Recruiting
CIDP
New Delhi, 110005
Kaur Sumit, MD, 00911140793385, info@cidp-cro.com
Pranami Kashyap, MD
Singapore1 site
- Suspended
KK Women's & Children's Hospital
Singapore, Singapore, 179939
About this study
Official title: Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin
Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group. 5 visits: inclusion visit [day (D) 0] and 4 follow-up visits (D30, D60, D90, and D120).
Read the detailed description
This is a prospective, double blind, multicentric and comparative study including 5 visits (on D0 which corresponds to inclusion visit, D30, D60, D90, and D120). It will take place from June 2024 to June 2025 in Argentina (CIREC LATAM, Buenos Aires) and India (CIDP, New Dheli). This study will include 100 patients (50 in India and 50 in Argentina) who will be followed up for 120 days (± 3 days).
- Conditions
- Atopic Dermatitis, Eczema, Atopic
- Being tested
- Skin hydration, Barrier function measurement, Potential of hydrogen measurement (pH), Clinical evaluation of atopic dermatitis, Quality of life assessment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin hydrationOther
Also called Corneometer
Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Barrier function measurementOther
Also called Transepidermal Water Loss (TEWL)
TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Potential of hydrogen measurement (pH)Other
pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Clinical evaluation of atopic dermatitisOther
Also called Eczema Area and Severity Index (EASI)
EASI score on each visit. Non invasive technique.
Quality of life assessmentOther
Cardiff questionnaires to assess quality of life of subjects and their family members.
Assessment of the effect on itching and sleep disturbancesOther
Visual analogue scale from 0 to 10
Assessment of the tolerance of the study product or placeboOther
By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).
| Study group | Role | What they receive |
|---|---|---|
| Investigational product (BI 479 V1) | Active comparator | The study product or placebo will be applied twice daily on a clean and dry skin for 120 days. Follow "3-6-9 method" as follows: for babies (6 months to 24 months) use 3 pumps for the whole body (1 pump for face, 1 pump for trunk and arms and 1 pump for lower limbs), for children from 25 months: use 6 pumps for the whole body (1 pump for face, 3 pumps for trunk and arms and 2 pumps for lower limbs) and for children with height greater than 1.5 meters: use 9 pumps for the whole body (1 pump for face, 1 pump for chest, 1 pump for back, 1 pump per arm (x2) and 2 pumps per leg (x2). It will be applied from inclusion visit simultaneously with topical treatment in the following order: first the study product or placebo on the whole body followed by the topical treatment on the flare-up areas. Receives: Other: Skin hydration; Other: Barrier function measurement; Other: Potential of hydrogen measurement (pH); Other: Clinical evaluation of atopic dermatitis; Other: Quality of life assessment; Other: Assessment of the effect on itching and sleep disturbances; Other: Assessment of the tolerance of the study product or placebo |
| Placebo (BI 006) | Placebo comparator | Same instructions of use as active comparator. Receives: Other: Skin hydration; Other: Barrier function measurement; Other: Potential of hydrogen measurement (pH); Other: Clinical evaluation of atopic dermatitis; Other: Quality of life assessment; Other: Assessment of the effect on itching and sleep disturbances; Other: Assessment of the tolerance of the study product or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)
Clinical evaluation by dermatologist on each visit and daily log statements by the parents.
Measured: 4 months
Secondary outcomes (10)
Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI)
Clinical evaluation by dermatologist on each visit. Minimum value: 0; maximum value:72. Higher scores mean worse outcome.
Measured: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA)
Clinical evaluation by dermatologist on each visit. Minimum value: 0; maximum value:4. Higher scores mean worse outcome.
Measured: 0-30, 31-60, 61-90 and 91-120 days of treatment
Tolerance of the study product or placebo
Collection of treatment-related adverse events during the study
Measured: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change of stratum corneum (SC) hydration.
Measurement performed with -Corneometer® CM825 (Courage + Khazaka) and MPACT + software (Monaderm). Subjects must not have applied anything to the forearms on the morning of the measurements. Subject acclimatize for at least 15 minutes in the lab under standardised conditions, with bare test area: - room temperature: 20-22°C;
- relative humidity: 40-60%. Dry skin area (the same in all visits): the most recommended area are the forearms (avoid flare-up areas). Minimum value: 0; maximum value:60. Higher scores mean better outcome.
Measured: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change on the trans-epidermal water loss (TEWL).
Measurement performs with - Tewameter® TM Hex (Courage \& Khazaka) and MPACT + software (Monaderm). Subjects must not have applied anything to the forearms on the morning of the measurements. Subject acclimatize for at least 15 minutes in the lab under standardised conditions, with bare test area: - room temperature: 20-22°C;
- relative humidity: 40-60%. Dry skin area (the same in all visits): the most recommended area are the forearms (avoid flare-up areas). Minimum value: 0; maximum value:20. Higher scores mean worse outcome.
Measured: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change on the pH.
Measurement perform with LAQUA pHmeter PHD72G. Subject must not have applied anything to the forearms on the morning of the measurements. Subject acclimatize for at least 15 minutes in the lab under standardised conditions, with bare test area: - room temperature: 20-22°C;
- relative humidity: 40-60%. Dry skin area (the same in all visits): the most recommended area are the forearms (avoid flare-up areas). Minimum value: 0; maximum value:14. pH higher than 5,9 or lower than 4,5 scores mean worse outcome.
Measured: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change on itching
Interview by dermatologist on each visit. Minimum value: 0; maximum value:10. Higher scores mean worse outcome.
Measured: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change on sleep disturbances.
Interview by dermatologist on each visit. Minimum value: 0; maximum value:10. Higher scores mean worse outcome.
Measured: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change on quality of life.
Cardiff quality of life questionnaires fill in by subjects or parents according to age range. The total score is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The questionnaires can also be expressed as a percentage of the maximum possible score of 30.
Measured: 0-30, 31-60, 61-90 and 91-120 days of treatment
Subjective appreciation of efficacy and acceptability by the parent(s)/legal representative(s) and/or their child.
Questionnaire fill in by representative(s) and/or their child. Score from "totally agree" to "totally disagree". "Totally agree" and "agree" are considered positive answers (in percentage). Somewhat agree and and totally disagree are considered negative answers (in percentage). The questionnaires are expressed as a percentage.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start3 Nov 2022
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NAOS Argentina S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575882
- Sponsor's protocol ID
- RC2022/PSagc/SG-AR
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2022
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gayraud F, Sayag M, Jourdan E. Efficacy and tolerance assessment of a new type of dermocosmetic in infants and children with moderate atopic dermatitis. J Cosmet Dermatol. 2015 Jun;14(2):107-12. doi: 10.1111/jocd.12145. Epub 2015 Mar 23.
PubMed 25807867
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin
- ClinicalTrials.gov ID
- NCT05575882
- Acronym / sponsor ID
- RC2022/PSagc/SG-AR
- Conditions
- Atopic Dermatitis, Eczema, Atopic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NAOS Argentina S.A.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 12 Oct 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.
Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group. 5 visits: inclusion visit [day (D) 0] and 4 follow-up visits (D30, D60, D90, and D120).
Detailed description
This is a prospective, double blind, multicentric and comparative study including 5 visits (on D0 which corresponds to inclusion visit, D30, D60, D90, and D120). It will take place from June 2024 to June 2025 in Argentina (CIREC LATAM, Buenos Aires) and India (CIDP, New Dheli). This study will include 100 patients (50 in India and 50 in Argentina) who will be followed up for 120 days (± 3 days).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group.
| Arm | Type | Receives |
|---|---|---|
| Investigational product (BI 479 V1) | Active comparator | Other: Skin hydration, Other: Barrier function measurement, Other: Potential of hydrogen measurement (pH), Other: Clinical evaluation of atopic dermatitis, Other: Quality of life assessment, Other: Assessment of the effect on itching and sleep disturbances, Other: Assessment of the tolerance of the study product or placeboThe study product or placebo will be applied twice daily on a clean and dry skin for 120 days. Follow "3-6-9 method" as follows: for babies (6 months to 24 months) use 3 pumps for the whole body (1 pump for face, 1 pump for trunk and arms and 1 pump for lower limbs), for children from 25 months: use 6 pumps for the whole body (1 pump for face, 3 pumps for trunk and arms and 2 pumps for lower limbs) and for children with height greater than 1.5 meters: use 9 pumps for the whole body (1 pump for face, 1 pump for chest, 1 pump for back, 1 pump per arm (x2) and 2 pumps per leg (x2). It will be applied from inclusion visit simultaneously with topical treatment in the following order: first the study product or placebo on the whole body followed by the topical treatment on the flare-up areas. |
| Placebo (BI 006) | Placebo comparator | Other: Skin hydration, Other: Barrier function measurement, Other: Potential of hydrogen measurement (pH), Other: Clinical evaluation of atopic dermatitis, Other: Quality of life assessment, Other: Assessment of the effect on itching and sleep disturbances, Other: Assessment of the tolerance of the study product or placeboSame instructions of use as active comparator. |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- General criteria:
- Healthy subject (except AD and other atopic diseases - allergic rhinitis, conjunctivitis, and asthma). The subject can keep its usual treatment (antihistamines, inhaled corticosteroids, and antileukotriene treatment) during the study if applicable. Written informed consent from the subject's parent(s)/legal representative(s) and children over 8 years old (specific Argentina) and over 12 years old (specific Singapore). Subject accepting to continue the normal conditions of hygiene and sunscreen (if applicable). Subject, parents/legal representative(s) willing to adhere to the study protocol and procedures.
- Sex: male or female. Age: from 6 months to 15 years. Subject having on average one flare-up per month during the four months preceding the study, including the one observed on the inclusion visit D0. Subject having EASI value from 7.1 - 21 on D0 (moderate AD). Subject having one atopic eruption on the inclusion visit which the dermatologist will prescribe topical corticosteroids or calcineurin's inhibitors (pimecrolimus and/or tacrolimus).
Key exclusion criteria (1 listed)
- Subject presenting cutaneous pathology in the studied zone other than AD (according to the investigator's appreciation, i.e., acne, psoriasis). Subject using systemic treatment, including oral steroids and oral immunosuppressants e.g., ciclosporin during the previous weeks liable to interfere with the assessment of the cutaneous tolerance of the study product or placebo (according to the investigator's appreciation). Subject using skin-moisturizing products from inclusion (D0) other than the study product or placebo. Subject who had systemic therapy with immune-suppressive drugs and antibiotics within the last 14 days before the beginning of the study Subject having serious illness that might require regular systemic medication (e.g., insulin-dependent diabetes, cancer) or conditions that exclude a participation or might influence the study evaluation. Subject with documented allergies to the study product or placebo ingredients. Subject enrolled in another clinical study during the study period. Parent(s)/legal representative(s) considered by the investigator to be likely not compliant to the protocol.
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 |
|---|---|---|
| Skin hydrationAlso: CorneometerSkin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique. | Other | Investigational product (BI 479 V1), Placebo (BI 006) |
| Barrier function measurementAlso: Transepidermal Water Loss (TEWL)TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique. | Other | Investigational product (BI 479 V1), Placebo (BI 006) |
| Potential of hydrogen measurement (pH)pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique. | Other | Investigational product (BI 479 V1), Placebo (BI 006) |
| Clinical evaluation of atopic dermatitisAlso: Eczema Area and Severity Index (EASI)EASI score on each visit. Non invasive technique. | Other | Investigational product (BI 479 V1), Placebo (BI 006) |
| Quality of life assessmentCardiff questionnaires to assess quality of life of subjects and their family members. | Other | Investigational product (BI 479 V1), Placebo (BI 006) |
| Assessment of the effect on itching and sleep disturbancesVisual analogue scale from 0 to 10 | Other | Investigational product (BI 479 V1), Placebo (BI 006) |
| Assessment of the tolerance of the study product or placeboBy collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF). | Other | Investigational product (BI 479 V1), Placebo (BI 006) |
Primary outcome
Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)
Time frame: 4 months
Clinical evaluation by dermatologist on each visit and daily log statements by the parents.
10 secondary outcomes
Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI)
Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA)
Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
Tolerance of the study product or placebo
Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change of stratum corneum (SC) hydration.
Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change on the trans-epidermal water loss (TEWL).
Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change on the pH.
Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change on itching
Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change on sleep disturbances.
Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change on quality of life.
Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
Subjective appreciation of efficacy and acceptability by the parent(s)/legal representative(s) and/or their child.
Time frame: 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Results publication: PubMed 25807867Gayraud F, Sayag M, Jourdan E. Efficacy and tolerance assessment of a new type of dermocosmetic in infants and children with moderate atopic dermatitis. J Cosmet Dermatol. 2015 Jun;14(2):107-12. doi: 10.1111/jocd.12145. Epub 2015 Mar 23.
- Individual participant dataSharing planned: No
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin hydration, Barrier function measurement and Potential of hydrogen measurement (pH) in people with Atopic Dermatitis and Eczema, Atopic, run by NAOS Argentina S.A. at 3 sites in 3 countries.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina, India, Singapore. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of acute flares of eczema in patients with chronic atopic dermatitis (AD) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05575882, which also lists 1 linked publication.
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 25 Mar 2025.