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

Launched by AILEENS PHARMA SRL · Aug 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a cream called LimpiAD, which contains 2.5% active ingredients, to see how well it works for treating mild to moderate atopic dermatitis, a skin condition that causes itchy, inflamed skin. The trial will compare LimpiAD cream to a similar cream without the active ingredients (called its "vehicle") and to a basic moisturizing cream. The goal is to find out which option is more effective and better tolerated by patients.

To be eligible for the study, participants must be between 6 months and 16 years old, in good health, and have been diagnosed with atopic dermatitis that meets specific severity criteria. Parents or guardians will need to provide consent for their child to participate and agree to attend follow-up visits. Participants will apply the creams as directed and will be monitored for changes in their skin condition and any side effects. It’s important to note that some treatments and medications may exclude potential participants, so a careful review of medical history will be conducted before enrollment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Subjects of both sexes, between 6 months and 16 years of age, Caucasian, in good health, whose parents/tutors provided a written and signed informed consent for participation in the study shall be enrolled. In particular, as regards parents/tutors:
• • Both parents/tutors, in case of joint custody, must 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 must accept to bring the child to the clinical trial facility on predefined visit days according to the instructions provided by the investigators;
• • They must be willing and be able to follow the trial requirements provided by the investigators.
• The inclusion criteria provide that:
• • 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).
• 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 weeks prior to treatment;
• • Ongoing use at baseline of antibiotics and systemic anti-inflammatory drugs for AD in the 2 weeks preceding treatment and during the study (paracetamol is allowed at dosages and indications recommended for use as an antipyretic and analgesic);
• • Baseline treatment with anti-inflammatory drugs, antihistamines, antitussives and/or inhaled steroids in the 2 previous weeks, retinoids and/or immunosupressants in the previous 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 systemic treatment 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 invalidate clinical assessments or overlap with AD skin picture;
• • Systemic diseases which may affect the subject's safety or wellbeing or interfere with skin response.