Clinical Comparison of LimpiAD Cream 2.5% Plus, Vehicle and an Emollient in Pediatric Patients With Atopic Dermatitis
The purpose of this randomized clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5% Plus cream and a standard emollient used as neutral control, which represents the basic standard treatment (basic therapy) of AD according to European Guidelines in pediatric subjects with mild to moderate Atopic Dermatitis.
⁃ Subjects of both sexes, with age ranging between 2 years and 16 years, Caucasian and in good health, whose parents/tutors provided a written and signed informed consent for their participation in the study shall be enrolled. In particular, as regards parents/tutors:
• both parents/tutors, in case of joint custody, should provide a written and signed informed consent for the participation of the child in the study, according to the instructions provided by the Investigators.
• they should accept to bring the child to the clinical trial facility on predefined visit days, according to the instructions provided by the Investigators;
• they should be willing and able to follow the trial requirements provided by the Investigators.
• Symptoms and signs compatible with a clinical diagnosis of Atopic Dermatitis should be present upon enrollment;
• The clinical severity of AD should correspond to an EASI ranging between 1.0 and 21.0 and an IGA equal to 2 or 3;
• Pruritus severity assessed by means of VAS scale ≥ 4 cm) should be referred to the part of the body to be treated, as a requirement for inclusion in the study;
• The clinical assessment should envisage for the patient the indication of a moisturizing/emollient treatment as single therapy for AD (in accordance with European Guidelines on AD treatment).