Resumen

Estudio clínico comparativo, multicéntrico, doble ciego y aleatorizado en Argentina y Brasil. Bajo control dermatológico y oftalmológico. 4 visitas: inclusión [Día (D)0], D28, D56, D84. Se requiere aprobación del comité de ética.

Descripción detallada

Objetivo primario: Evaluar la eficacia de dos productos cosméticos (SCARCr tester 1 y SCARCr tester 2) en asociación con el tratamiento médico tópico (ivermectina o metronidazol) para favorecer la mejoría del enrojecimiento persistente debido a la rosácea y aliviar las sensaciones de malestar, bajo control dermatológico y oftalmológico. Objetivos secundarios: Evaluar la tolerancia cutánea y ocular de dos productos cosméticos en sujetos con rosácea bajo tratamiento con ivermectina o metronidazol tópico durante 56 días, y 28 días después de aplicar los productos cosméticos solos. Evaluar la eficacia de dos productos cosméticos mediante evaluación clínica de los síntomas relacionados con la rosácea después de 56 días de uso concomitante del producto cosmético con el tratamiento médico tópico, y 28 días después de aplicar los productos cosméticos solos. Evaluar la eficacia de dos productos cosméticos mediante mediciones instrumentales del enrojecimiento después de 56 días de uso concomitante del producto cosmético con el tratamiento médico tópico, y 28 días después de aplicar los productos cosméticos solos. Evaluar la evolución de la calidad de vida de los sujetos durante el período de uso de la asociación del tratamiento médico tópico con los productos cosméticos (56 días) y 28 días después de aplicar los productos cosméticos solos. Evaluar la eficacia inmediata y a largo plazo y las cualidades cosméticas de los productos cosméticos basándose en cuestionarios de autoevaluación por los sujetos. Comparar la tolerancia y eficacia de los dos productos.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: FEMALE

Criterios de inclusión

Subject with facial vascular rosacea with flushing, permanent redness, telangiectasias and at least 3 papules and/or pustules (this last criterion for at least 10 subjects per group)
Subject starting local treatment for rosacea (Ivermectin or metronidazole)
Female aged 18 to 65 years old,
Subject of all types of skin
Subject of I to IV phototype.
Subject accepting not to use any type of facial skin care other than the study product
Subject willing to keep their usual habits and products (hygiene products, sunscreen, and make-up, if applicable)
Subject willing to avoid sun exposure during the study period
Subject willing to actively participate in the study and to come to the scheduled visits
Subject that has signed informed consent

Criterios de exclusión

Pregnant or breastfeeding woman
Subject showing cutaneous marks on the experimental areas, which could interfere with the assessment of skin reactions (pigmentation troubles, scar elements, over-developed pilosity, ephelides and naevi in too great quantity, sunburn)
Subject with documented allergy or reactivity to products of the same category than the tested one
Subject with documented allergies to study product components
Subject with history of malignant melanomas (Dubreuilh melanosis…)
Subject with unbalanced hormonal treatment
Subject with forecast of initiation of a hormonal treatment or change of the usual hormonal treatment during the study period
Subject with forecast of sun or UVA exposure (UV lamps) during the study period
Subject not willing to use sun protective clothes orhat if exposed to the sun
Subject not willing to respect the methods of use of the treatment, study product and sunscreen
Subject with anti-ageing or aesthetic treatment during the last 6 months: botox or botox like products, peelings, plastic surgery, hyaluronic acid treatment, Plasma Rich Platelets treatment, or any other specific treatments prone to change the skin aspect
Subject with antibiotic, anti-allergic, anti-inflammatory treatment or treatment with patent medicines containing Vitamin A acid or its derivatives within 4 weeks and during the study (if therapeutic requirement: exclusion foreseen),
Subject with systemic disorder: cardiovascular, pulmonary, digestive, neurologic, psychiatric, genital, urinary, haematological, endocrine
Subject presenting chronic diseases with impact on skin
Subject who has undergone a bilateral mastectomy with lymph node removal, a unilateral mastectomy with lymph node removal within the last year, or a bilateral axillary lymph node removal,
Subject with a history of immune deficiency or auto-immune disease, treated for malignancy within 6 months prior to enrolment or who are currently under treatment for asthma or diabetes, forecast of vaccination during the test period or last vaccination within 3 weeks before the study.
Subject receiving local treatment for rosacea (cyclins, isotretinoin) or who has undergone local active treatment for rosacea (erythromycin, metronidazole, benzoyl peroxide, ivermectin) within 4 weeks before inclusion in the study
Subject who has had oral treatment with metronidazole or cyclins within 4 weeks before inclusion in the study
Subject who has had topical or oral anti-inflammatory and/or antiallergy treatment (corticosteroid, antihistamine, anti-inflammatory drugs, immunosuppressives) within 4 weeks before inclusion in the study
Subject who has had oral treatment with retinoids within 2 months before inclusion in the study
Subject currently receiving electrocoagulation or laser treatment for telangiectasia

Evaluación de la eficacia y tolerancia de dos productos cosméticos en sujetos con rosácea tratados con tratamiento tópico

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

SCARCr tester 1

Placebo

Ubicaciones

Cirec Latam

Patrocinadores