Anti-relapse efficacy and toleranceassessment of a cosmetic cream intended forvery dry, irritated to atopic sensitive skin - NI

AOS LES LABORATOIRES0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

研究概览

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•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 and informed consent from the subject’s parent(s)or legal representatives and children over 8
•years old specific Argentine and over 12 years old specific India.
•Subject accepting to continue the normal conditions of hygiene and sunscreen if applicable.
•Subject, parents/legal representatives 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 on which the dermatologist will prescribe
•topical corticosteroids or calcineurin’s inhibitors pimecrolimus and/or tacrolimus.

•Subject presenting cutaneous pathology in the studied zone other than AD according to the
•investigators 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 viral lesions, fungal and bacterial skin infections, parasitic infections,
•ulcers and wounds 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.
•Parents/legal representatives considered by the investigator to be likely not compliant to the

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