Phase
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
Ages 6-15 All Genders
Study Summary
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
Study Description
Connect with a study center
Cirec Latam
Ciudad Autónoma de Buenos Aire, 1426
ArgentinaSite Not Available
CIDP
New Delhi, 110005
IndiaActive - Recruiting
KK Women's & Children's Hospital
Singapore, 179939
SingaporeSuspended
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