Comparison of LimpiAD Cream 2.5% Plus Versus Its Vehicle and and a Basic Emollient in Patients With Atopic Dermatitis

Inclusion Criteria:

• Subjects of both sexes, between 6 months and 16 years of age, Caucasian, in goodhealth, whose parents/tutors provided a written and signed informed consent forparticipation in the study shall be enrolled. In particular, as regardsparents/tutors:
• Both parents/tutors, in case of joint custody, must provide a written and signedinformed consent for the participation of the child in the study according to theinstructions provided by the investigators;
• They must accept to bring the child to the clinical trial facility on predefinedvisit days according to the instructions provided by the investigators;
• They must be willing and be able to follow the trial requirements provided by theinvestigators. The inclusion criteria provide that:
• Symptoms and signs compatible with a clinical diagnosis of Atopic Dermatitis should bepresent upon enrollment;
• The clinical severity of AD should correspond to an EASI ranging between 1.0 and 21.0and an IGA equal to 2 or 3;
• Pruritus severity assessed by means of VAS scale ≥ 4 cm should be referred to the partof the body to be treated, as a requirement for inclusion in the study;
• The clinical assessment should envisage for the patient the indication of amoisturizing/emollient treatment as single therapy for AD (in accordance with EuropeanGuidelines on AD treatment).

Exclusion Criteria: The following items are to be considered as exclusion criteria:

• The application of cortisone-based products on the skin to be treated in the 2 weeksprior to treatment;
• Ongoing use at baseline of antibiotics and systemic anti-inflammatory drugs for AD inthe 2 weeks preceding treatment and during the study (paracetamol is allowed atdosages and indications recommended for use as an antipyretic and analgesic);
• Baseline treatment with anti-inflammatory drugs, antihistamines, antitussives and/orinhaled steroids in the 2 previous weeks, retinoids and/or immunosupressants in theprevious 6 months.
• Use of systemic steroids in the 4 weeks prior to the study.
• Intense and prolonged sun exposure in the 30 days preceding the screening.
• Severe AD (EASI > 21) or mild/moderate AD requiring any local and/or systemictreatment comprised in the prohibited treatments included in the exclusion criteria;
• Hypersensitivity to the study products.
• Acute or chronic skin diseases - except for atopic eczema - which may invalidateclinical assessments or overlap with AD skin picture;
• Systemic diseases which may affect the subject's safety or wellbeing or interfere withskin response.