Comparing LimpiAD Cream with a Vehicle and Basic Emollient for Atopic Dermatitis

Comparative Clinical Trial Between LimpiAD 2.5% Plus Cream, Its Vehicle and a Basic Emollient in Atopic Dermatitis in Paediatric Age

This study is testing a new cream called LimpiAD to see if it helps kids with mild to moderate eczema feel better compared to a basic lotion and the cream without active ingredients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 6 Months to 16 Years
• Sex: All
• Sponsor: Aileens Pharma SRL (industry)
• Locations: 5 sites (Castellammare di Stabia, Napoli and 4 other locations)
• Trial ID: NCT05984420 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and tolerability of LimpiAD, a 2.5% Plus cream, in comparison to its vehicle and a basic emollient in pediatric patients with mild to moderate Atopic Dermatitis. The study is designed as a controlled, randomized, double-blind, multicenter trial involving 200 subjects aged 6 months to 16 years. Participants will receive treatment twice daily for 8 weeks, followed by a 12-week follow-up to assess outcomes. Clinical assessments will be conducted at multiple time points to monitor the condition's severity and treatment response.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 months to 16 years with mild to moderate Atopic Dermatitis.

Not a fit: Patients with severe Atopic Dermatitis or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective new option for managing Atopic Dermatitis in children.

How similar studies have performed: Other studies have shown promise with similar topical treatments for Atopic Dermatitis, suggesting potential for success in this approach.

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.

Where this trial is running

Castellammare di Stabia, Napoli and 4 other locations

• Dr. Chianese Pierluigi — Castellammare di Stabia, Napoli, Italy (RECRUITING)
• Dr. Carlomagno Francesco — Nola, Napoli, Italy (RECRUITING)
• Dr. D'Onofrio Antonietta — Pomigliano d'Arco, Napoli, Italy (NOT_YET_RECRUITING)
• Dr. Giuseppe Ruggiero — Battipaglia, Salerno, Italy (RECRUITING)
• Dr. Occhinegro Aurelio — Salerno, Italy (RECRUITING)

Study contacts

• Principal investigator: Ruggiero Giuseppe, MD — ASL Salerno
• Study coordinator: Marco Alfio Cutuli, PharmD

Conditions: Atopic Dermatitis, pediatric atopic dermatits, topical medical device, LimpiAD, eczema