Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.

Last updated: March 21, 2025
Sponsor: NAOS Argentina S.A.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atopic Dermatitis

Allergy

Eczema (Atopic Dermatitis)

Treatment

Assessment of the tolerance of the study product or placebo

Quality of life assessment

Skin hydration

Clinical Study ID

NCT05575882
RC2022/PSagc/SG-AR
  • Ages 6-15
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subject presenting cutaneous pathology in the studied zone other than AD (accordingto the investigator's appreciation, i.e., acne, psoriasis). Subject using systemictreatment, including oral steroids and oral immunosuppressants e.g., ciclosporinduring the previous weeks liable to interfere with the assessment of the cutaneoustolerance of the study product or placebo (according to the investigator'sappreciation). Subject using skin-moisturizing products from inclusion (D0) otherthan the study product or placebo. Subject who had systemic therapy withimmune-suppressive drugs and antibiotics within the last 14 days before thebeginning of the study Subject having serious illness that might require regularsystemic medication (e.g., insulin-dependent diabetes, cancer) or conditions thatexclude a participation or might influence the study evaluation. Subject withdocumented allergies to the study product or placebo ingredients. Subject enrolledin another clinical study during the study period. Parent(s)/legal representative(s)considered by the investigator to be likely not compliant to the protocol.

Study Design

Total Participants: 100
Treatment Group(s): 7
Primary Treatment: Assessment of the tolerance of the study product or placebo
Phase:
Study Start date:
November 03, 2022
Estimated Completion Date:
November 30, 2025

Study 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).

Connect with a study center

  • Cirec Latam

    Ciudad Autónoma de Buenos Aire, 1426
    Argentina

    Site Not Available

  • CIDP

    New Delhi, 110005
    India

    Active - Recruiting

  • KK Women's & Children's Hospital

    Singapore, 179939
    Singapore

    Suspended

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