Comparison of LimpiAD Cream 2.5% Plus Versus Vehicle and an Emollient in Patients With Atopic Dermatitis
NCT ID: NCT05971355
Last Updated: 2024-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2021-03-10
2024-12-31
Brief Summary
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Detailed Description
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This is a randomized, double-blind, multicenter, stratified, clinical trial of the medical device LimpiAD 2.5% Plus cream versus the vehicle of this medical device and versus an emollient in pedriatic Atopic Dermatitis patients that will be randomized in a 2:2:1 fashion to the compound mentioned above.
The study aims to enrol two hundred (200) pediatric subjects of both sexes, with an age ranging between 2 years old and 16 years old with atopic dermatitis of which at least 50 with mild severity (EASI 1.0-7.0 and IGA = 2) and 50 cases with moderate severity (EASI 7.1-21.0 and IGA = 3).
The treatment with the study product or with the control products shall be performed twice daily (morning and evening) after cleansing, for 4 weeks.
Clinical assessments shall be performed at baseline (T0) and after 2 and 4 weeks (T2 and T4) by means of a daily reminder diary.
The primary endpoint is the EASI improvement. The improvement shall be calculated by comparing the baseline value (T0) with the corresponding value at week 4 (T4) for LimpiAD 2.5% Plus cream versus the vehicle of LimpiAD 2.5% Plus cream and versus the emollient, in terms of detected score reduction (total EASI score).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment group
LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks.
LimpiAD cream 2,5% plus
A topical formulation that contains Hyaluronic Acid conjugated with a bacterial wall fragment of Cutibacterium species (HAc-40) and an emollient base. LimpiAD exerts its post-biotic action through the seizure/ trapping and inactivation of catabolites and / or toxins produced by S. aureus as well as protecting the hydrolipidic film, especially in case of dryness, itching, and, in conditions of altered microbiome
Control group
Vehicle of LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks.
Vehicle
Vehicle of LimpiAD cream 2.5 % plus which has the qualities of an emollient technically enriched with active ingredients known for their use in AD ("plus" emollient) - having the same ingredients of LimpiAD 2.5% Plus cream but without the HAc-40 component.
Emollient group
Emollient cream to be applied twice a day (morning and evening) for 4 weeks.
Emollient
Standard emollient used as neutral control, having only a moisturizing and skin barrier action, which represents the basic standard treatment (basic therapy) of atopic dermatitis according to the European Guidelines.
Interventions
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LimpiAD cream 2,5% plus
A topical formulation that contains Hyaluronic Acid conjugated with a bacterial wall fragment of Cutibacterium species (HAc-40) and an emollient base. LimpiAD exerts its post-biotic action through the seizure/ trapping and inactivation of catabolites and / or toxins produced by S. aureus as well as protecting the hydrolipidic film, especially in case of dryness, itching, and, in conditions of altered microbiome
Vehicle
Vehicle of LimpiAD cream 2.5 % plus which has the qualities of an emollient technically enriched with active ingredients known for their use in AD ("plus" emollient) - having the same ingredients of LimpiAD 2.5% Plus cream but without the HAc-40 component.
Emollient
Standard emollient used as neutral control, having only a moisturizing and skin barrier action, which represents the basic standard treatment (basic therapy) of atopic dermatitis according to the European Guidelines.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
* 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.
2 Years
16 Years
ALL
No
Sponsors
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Aileens Pharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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Francesca Farnetani, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Modena e Reggio Emilia
Locations
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University of Bari Hospital
Bari, , Italy
University of Modena e Reggio Emilia
Modena, , Italy
University of Naples Hospital
Naples, , Italy
S. Gallicano Hospital
Rome, , Italy
University Rome La Sapienza (Hospital Umberto I)
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LAD-09-20
Identifier Type: -
Identifier Source: org_study_id
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