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

Overview

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

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 Criteria:
          -  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.