Resumen

Estudio multicéntrico, doble ciego, aleatorizado, comparativo con dos grupos paralelos: grupo de estudio frente a grupo placebo. 5 visitas: visita de inclusión [día (D) 0] y 4 visitas de seguimiento (D30, D60, D90 y D120).

Descripción detallada

Este es un estudio prospectivo, doble ciego, multicéntrico y comparativo que incluye 5 visitas (en D0, que corresponde a la visita de inclusión, D30, D60, D90 y D120). Se llevará a cabo desde junio de 2024 hasta junio de 2025 en Argentina (CIREC LATAM, Buenos Aires) e India (CIDP, Nueva Delhi). El estudio incluirá a 100 pacientes (50 en India y 50 en Argentina) con un seguimiento de 120 días (± 3 días).

Elegibilidad

Edad mínima: 6 MonthsEdad máxima: 15 YearsSexo: ALL

Criterios de inclusión

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).

Criterios de exclusión

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.

Intervenciones

other

Skin hydration

Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

other

Barrier function measurement

TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

other

Potential of hydrogen measurement (pH)

pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

other

Clinical evaluation of atopic dermatitis

EASI score on each visit. Non invasive technique.

other

Quality of life assessment

Cardiff questionnaires to assess quality of life of subjects and their family members.

other

Assessment of the effect on itching and sleep disturbances

Visual analogue scale from 0 to 10

other

Assessment of the tolerance of the study product or placebo

By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).

Evaluación de la eficacia antirrecaída y tolerancia de una crema cosmética destinada a pieles muy secas, irritadas o sensibles atópicas

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Skin hydration

Barrier function measurement

Potential of hydrogen measurement (pH)

Clinical evaluation of atopic dermatitis

Quality of life assessment

Assessment of the effect on itching and sleep disturbances

Assessment of the tolerance of the study product or placebo

Ubicaciones

Cirec Latam

Patrocinadores