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.
Plain-language title generated from the registry record
Registry title: Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.
Key facts
- Where
- New Delhi, IndiaSee the site
AI summary: who the study is looking for
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
Read by machine on 9 November 2026.
Where in India
- CIDPNew Delhi, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NAOS Argentina S.A.
- Trial code
- NCT05575882
- Record updated
- 25 March 2025
- Original description
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 full original descriptionShow less
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).
Inclusion: 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).
Exclusion: 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.