Comparing LimpiAD Cream to Standard Treatments for Atopic Dermatitis in Children

Clinical Comparison of LimpiAD Cream 2.5% Plus, Vehicle and an Emollient in Pediatric Patients With Atopic Dermatitis

This study is testing a new cream called LimpiAD to see if it works better than standard treatments for kids aged 2 to 16 with mild to moderate eczema.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 2 Years to 16 Years
• Sex: All
• Sponsor: Aileens Pharma SRL (Industry-sponsored)
• Locations: 5 sites (Bari and 4 other locations)
• Trial ID: NCT05971355 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and tolerability of LimpiAD 2.5% Plus cream in treating pediatric patients with mild to moderate atopic dermatitis. It is a randomized, double-blind, multicenter trial that compares LimpiAD to a vehicle cream and a standard emollient. The study will enroll 200 participants aged 2 to 16, who will apply the treatments twice daily for four weeks. Clinical assessments will be conducted at baseline and after two and four weeks to measure improvements in atopic dermatitis severity.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 2 to 16 years with mild to moderate atopic dermatitis.

Not a fit: Patients with severe atopic dermatitis or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for managing atopic dermatitis in children.

How similar studies have performed: Other studies have shown positive outcomes with similar topical treatments for atopic dermatitis, suggesting potential for success in this approach.

Eligibility criteria

Inclusion criteria

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.

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;
* use 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);
* ongoing baseline treatment (T0) with anti-inflammatory drugs, antihistamines, antitussives and/or inhaled steroids in the 2 previous weeks, retinoids and/or immunosuppressants 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 a local and/or systemic treatment included among treatments not allowed, as provided for in 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.

Where this trial is running

Bari and 4 other locations

• University of Bari Hospital — Bari, Italy (Recruiting)
• University of Modena e Reggio Emilia — Modena, Italy (Recruiting)
• University of Naples Hospital — Naples, Italy (Recruiting)
• S. Gallicano Hospital — Rome, Italy (Terminated)
• University Rome La Sapienza (Hospital Umberto I) — Rome, Italy (Recruiting)

Study contacts

• Principal investigator: Francesca Farnetani, Prof — University of Modena e Reggio Emilia
• Study coordinator: Marco Alfio Cutuli, M.Sc.

Conditions Atopic Dermatitis; Atopic dermatitis; topical treatment; pediatric atopic dermatitis; atopic eczema; LimpiAD