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.