An interventional study of Skin hydration and Barrier function measurement in Atopic Dermatitis and Eczema, Atopic, sponsored by NAOS Argentina S.A.. Recruiting at 3 sites in 3 countries. Open to participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by NAOS Argentina S.A. · Not applicable, Interventional, and Prevention
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).
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).
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 100 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →NAOS Argentina S.A. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy subject (except AD and other atopic diseases - allergic rhinitis, conjunctivitis, and asthma). The subject can keep its usual treatment (antihistamines, inhaled , and antileukotriene treatment) during the study if applicable. Written 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).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Same instructions of use as 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 placebo
Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Also known as: Corneometer
TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Also known as: Transepidermal Water Loss (TEWL)
pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
EASI score on each visit. Non invasive technique.
Also known as: Eczema Area and Severity Index (EASI)
Cardiff questionnaires to assess quality of life of subjects and their family members.
Visual analogue scale from 0 to 10
By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).
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.
Time frame: 4 months
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.
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)
Clinical evaluation by dermatologist on each visit. Minimum value: 0; maximum value:4. Higher scores mean worse outcome.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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.
Time frame: 120 days
Not enrolling at this site.
Plan to share: No
Started Nov 2022 (actual). Primary completion is estimated for Oct 2025, 35 months after the start.
Of 69 industry-sponsored interventional studies with no phase under Dermatitis, Atopic, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 24. This study's planned 35 months is above that.
Counting every sponsor, half of 182 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NAOS Argentina S.A.