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Tests a cosmetic cream for atopic dermatitis that is very dry or irritated skin

Tests a moisturizing cosmetic cream against a placebo in children with atopic dermatitis.

Key facts

Who runs it
NAOS Argentina S.A.
Where
Ciudad Autónoma de Buenos Aire, ArgentinaSee the siteAlso in 2 other countries, 2 sites
Trial code
Registry title
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.
Status
Recruiting
People taking part
100 people, planned
Started
3 Nov 2022
Planned end
Nov 2025
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Skin hydration
  • Barrier function measurement
  • Potential of hydrogen measurement (pH)
  • Clinical evaluation of atopic dermatitis
  • Quality of life assessment
  • Assessment of the effect on itching and sleep disturbances
  • Assessment of the tolerance of the study product or placebo
Record updated
25 March 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with moderate atopic dermatitis (eczema) who have about one flare-up a month. It tests a cosmetic cream against a placebo.

Age
From 6 months to 15 years.
Sex
Boys and girls can both join.
Disease stage
Moderate atopic dermatitis, with an EASI value from 7.1 to 21 on day 0. A flare-up on day 0 that the dermatologist would treat with topical corticosteroids or calcineurin inhibitors.
Earlier treatment
About one flare-up per month in the four months before the study. No oral steroids or oral immunosuppressants in the previous weeks. No immune-suppressing drugs or antibiotics in the last 14 days.

Main reasons for not taking part

  • Another skin disease in the studied area, such as acne or psoriasis
  • Serious illness needing regular systemic medication, such as insulin-dependent diabetes or cancer
  • Known allergy to an ingredient of the study product or placebo
  • Using other skin-moisturizing products from day 0
  • Taking part in another clinical study

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • 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 take part

  • 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

Where in Argentina

Also in 2 other countries, 2 sites

  • Cirec LatamCiudad Autónoma de Buenos Aire, ArgentinaContact: Shantal Valdés, PhDNot yet recruiting

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Investigational product (BI 479 V1)Existing treatment, for comparison

    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.

    Treatment: Skin hydration, Barrier function measurement, Potential of hydrogen measurement (pH), Clinical evaluation of atopic dermatitis, Quality of life assessment, Assessment of the effect on itching and sleep disturbances, and Assessment of the tolerance of the study product or placebo

  • Placebo (BI 006)Placebo, for comparison

    Same instructions of use as active comparator.

    Treatment: Skin hydration, Barrier function measurement, Potential of hydrogen measurement (pH), Clinical evaluation of atopic dermatitis, Quality of life assessment, Assessment of the effect on itching and sleep disturbances, and Assessment of the tolerance of the study product or placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin
Plain-language title
Tests a cosmetic cream for atopic dermatitis that is very dry or irritated skinGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
25 March 2025