Assessment of moisturizing and recurring effect of the cosmetic cream on the whole body of age 6 months to 15 years of children using instruments and dermatologist evaluation.
- Registration Number
- CTRI/2024/05/068058
- Lead Sponsor
- AOS LES LABORATOIRES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method