None listed
Conditions
Interventions
Intervention1: Cosmetic cream: Product 1-Atoderm Intensive gel-creme (BI 479 V1)
Timepoints of Intervention-D0, D30, D60, D90, and D120
Zone of application: On whole body
Frequency of use: Twice daily
Sponsors
NAOS LES LABORATOIRES
Eligibility
Inclusion criteria
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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if the study product, when used twice daily for 120 days, can prevent recurring acute flare-ups of eczema in patients with chronic atopic dermatitis (AD) when compared to a placebo. Timepoint: D0, D30, D60, D90, and D120 | — |
Secondary
| Measure | Time frame |
|---|---|
| The following are the secondary goals To evaluate the severity & frequency of relapses Using the Investigators Global Assessment (IGA) & the Eczema Area & Severity Index (EASI), evaluate the overall improvement of AD. to gather Adverse Events (AEs) in order to gauge the study products or placebos tolerance In order to evaluate how well the stratum corneum (SC) is hydrated In order to evaluate the impact on transepidermal water loss (TEWL) In order to evaluate the impact on pH In order to evaluate the impact on itchiness & insomnia In order to evaluate the effect on life quality to evaluate the parent(s), legal representative(s), and/or childs subjective assessment of the programs effectiveness & acceptability Timepoint: D0, D30, D60, D90, & D120 | — |
Countries
Argentina, India
Contacts
Public ContactHirak Jyoti Nath
CIDP Biotech India Pvt. Ltd.
Outcome results
None listed