Atopic DermatitisNCT05984420
Comparison of LimpiAD Cream 2.5% Plus Versus Its Vehicle and and a Basic Emollient in Patients With Atopic Dermatitis
A study testing LimpiAD 2,5% plus cream and Emollient in people with Atopic Dermatitis, run by Aileens Pharma SRL at 5 sites in Italy.
Trial summary
The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the formulation of a 2.5% Plus cream, versus the Vehicle of LimpiAD 2,5% Plus cream, and versus a basic emollient in subjects with mild to moderate Atopic Dermatitis. Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LimpiAD 2,5% plus cream and Emollient
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesItaly
- Study dates
- 21 Apr 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Dr. Giuseppe Ruggiero
Battipaglia, Salerno, 84091
Giuseppe Ruggiero, MD
- Recruiting
Dr. Chianese Pierluigi
Castellammare di Stabia, Napoli, 80053
Pierluigi Chianese, MD
- Recruiting
Dr. Carlomagno Francesco
Nola, Napoli, 80035
Francesco Carlomagno, MD
- Not yet recruiting
Dr. D'Onofrio Antonietta
Pomigliano d'Arco, Napoli, 80038
Antonietta D'Onofrio, MD
- Recruiting
Dr. Occhinegro Aurelio
Salerno, 84090
Aurelio Occhinegro, MD
About this study
Official title: Comparative Clinical Trial Between LimpiAD 2.5% Plus Cream, Its Vehicle and a Basic Emollient in Atopic Dermatitis in Paediatric Age
The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the formulation of a 2.5% Plus cream, versus the Vehicle of LimpiAD 2,5% Plus cream, and versus a basic emollient in subjects with mild to moderate Atopic Dermatitis.
Read the detailed description
The objective of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the formulation of 2.5% Plus cream, versus the Vehicle of LimpiAD 2,5% Plus cream , and versus a basic emollient in subjects with mild to moderate Atopic Dermatitis.
STUDY DESIGN A controlled, 3-arms randomized, double-blind, multicentre clinical trial within subjects, stratified and balanced based on severity of the Atopic Dermatitis (AD) between LimpiAD 2.5% Plus cream, the Vehicle of LimpiAD 2.5% Plus cream and a basic standard treatment (basic therapy) of AD according to European Guidelines in pediatric subjects with mild to moderate AD.
SAMPLE SIZE Two hundred (200) subjects with Atopic Dermatitis, of whom at least 50 cases with mild severity Atopic Dermatitis (defined by EASI = Eczema Area and Severity Index = 1.0-7.0 and IGA= Investigator's Global Assessment =2) and 50 cases with moderate severity Atopic Dermatitis (defined by EASI 7.1-21.0 and IGA=3).
TREATMENT SCHEDULE AND METHODS Treatment with the investigational product or the control products will occur twice daily (morning and evening) for 8 weeks after cleansing of the treatment area. After the 8 weeks treatment period, the study subjects will undergo a follow-up visit after 12 weeks following the baseline visit (4 weeks after treatment completion).
Clinical assessments will be performed at baseline (T0), and after 2, 4, 8 and 12 weeks (T2, T4, T8 and T12) by means of a daily diary as a reminder.
Primary endpoint: statistically significant improvement of the EASI between T0 and T8 (p<0.05) in the treatment arm (LimpiAD 2.5% Plus cream ) as compared to the Vehicle of LimpiAD 2.5% Plus cream.
- Conditions
- Atopic Dermatitis
- Being tested
- LimpiAD 2,5% plus cream, Vehicle, Emollient
- Keywords
- pediatric atopic dermatits, topical medical device, LimpiAD, eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LimpiAD 2,5% plus creamDevice
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
VehicleOther
Vehicle of LimpiAD 2.5 % plus cream 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 but without the HAc-40 component.
EmollientOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group LimpiAD | Experimental | LimpiAD 2,5% plus cream to be applied twice a day (morning and evening) for 8 weeks Receives: Device: LimpiAD 2,5% plus cream |
| Control group Vehicle of LimpiAD | Active comparator | Vehicle of LimpiAD 2,5% plus cream to be applied twice a day (morning and evening) for 8 weeks. Receives: Other: Vehicle |
| Control group Emollient | Active comparator | Emollient standard cream to be applied twice a day (morning and evening) for 8 weeks. Receives: Other: Emollient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eczema Area and Severity Index (EASI)
The change shall be calculated by comparing the baseline value (T0) with the 2 weeks (T4), 4 weeks (T4) and 8 weeks (T8) values of LimpiAD 2.5% Plus cream versus the Vehicle of LimpiAD 2.5% Plus cream in terms of:
- score reduction detected (total EASI score)
INTERPRET EASI: Clear 0; Almost clear 0.1-1.0 ; Mild 1.1-7.0 ; Moderate 7.1-21.0 ; Severe 21.1-50.0; Very severe 50.1-72.0
Measured: Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Secondary outcomes (6)
Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis
The change shall be calculated by comparing the baseline value (T0) of IGA with the 2 weeks (T2), the 4 weeks (T4) and 8 weeks (T8) values in the treatment arm with LimpiAD 2.5% Plus cream as compared to the other 2 arms.
INTERPRET IGA: 0 - Not affected; 1 - Little affected; 2 - Mild erythema; 3 - Moderate erythema; 4 - Severe Marked erythema
Measured: Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Eczema Area and Severity Index (EASI) Change
The change shall be calculated, by comparing the baseline value (T0) with the 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8) values in the treatment arm with LimpiAD 2.5% Plus cream as compared to the other 2 arms in terms of:
- % of attainment of EASI <1 (corresponding to "healed/almost healed")
- % of patients reaching a 50% (EASI50), 75% (EASI75), 90% (EASI90) and 100% (EASI100) reduction in the baseline score.
Measured: Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Change in pruritus
Change in pruritus at the 4 weeks (T4) and 8 weeks (T8). By improvement we mean a Visual Analogue Scale (VAS) reduction below 4 cm, with at least 2-score deviation from baseline (T0), including only the cases with VAS > 5 cm at baseline, in the treatment arm with LimpiAD 2.5% Plus cream as compared to the other 2 treatment arms of the study.
In the visual analogue scale (VAS), patients are asked to mark on a 10-cm ruler ranging from 0 (no itch) to 10 (worst imaginable itch).
Measured: Baseline (T0), 4 weeks (T4) and 8 weeks (T8)
Change in sleep
Change in sleep at the 4 weeks (T4) and 8 weeks (T8). By improvement we mean a a Visual Analogue Scale (VAS) reduction below 4 cm, with at least 2-score deviation from baseline (T0), including only the cases with VAS > 5 cm at baseline, in the treatment arm with LimpiAD 2.5% Plus cream as compared to the other 2 treatment arms of the study.
In the visual analogue scale (VAS), patients are asked to mark on a 10-cm ruler ranging from 0 (no disturbance sleep) to 10 (very much disturbed sleep).
Measured: Baseline (T0), 4 weeks (T4) and 8 weeks (T8)
Change in extension and signs intensity of the target areas,
Change in extension and signs intensity of the target areas, assessed as local EASI, by separately considering the skin fold area with respect to the fold-free skin area at 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8) in the treatment arm with LimpiAD 2.5% Plus cream as compared to the other 2 treatment arms of the study.
Measured: Baseline (T0),2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Children's Dermatology Life Quality Index (CDLQI) questionnaire
Change in Children's Dermatology Life Quality Index (CDLQI): the change shall be calculated, by comparing the baseline total points (T0) with the corresponding total points at 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8) in the treatment arm with LimpiAD 2.5% Plus cream as compared to the other 2 study treatment arms in terms of:
-% of achievement of CDLQI <10
-CDLQI average score reduction
The CDLQI has 11 questions asking about the impact of a atopic dermatitis on the life of the affected child over the last week.
Interpretation of QoL: 0-2 = no effect on QoL, 3-7 small effect, 8-13 moderate effect, 14-19 very large effect, 20-33 extremely large effect
Measured: Baseline (T0),2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start21 Apr 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aileens Pharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advice Pharma Group srl
- Responsible party
- Sponsor
- Investigators
- Ruggiero Giuseppe, MD, Principal investigator, ASL Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984420
- Sponsor's protocol ID
- LAD-01-21
- Status last verified
- Feb 2024
- First submitted
- 25 Jul 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Trial Between LimpiAD 2.5% Plus Cream, Its Vehicle and a Basic Emollient in Atopic Dermatitis in Paediatric Age
- ClinicalTrials.gov ID
- NCT05984420
- Acronym / sponsor ID
- LAD-01-21
- Conditions
- Atopic Dermatitis
- Keywords
- pediatric atopic dermatits, topical medical device, LimpiAD, eczema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aileens Pharma SRLIndustry (pharma, biotech, devices)
- Collaborators
- Advice Pharma Group srl
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the formulation of a 2.5% Plus cream, versus the Vehicle of LimpiAD 2,5% Plus cream, and versus a basic emollient in subjects with mild to moderate Atopic Dermatitis.
Detailed description
The objective of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the formulation of 2.5% Plus cream, versus the Vehicle of LimpiAD 2,5% Plus cream , and versus a basic emollient in subjects with mild to moderate Atopic Dermatitis.
STUDY DESIGN A controlled, 3-arms randomized, double-blind, multicentre clinical trial within subjects, stratified and balanced based on severity of the Atopic Dermatitis (AD) between LimpiAD 2.5% Plus cream, the Vehicle of LimpiAD 2.5% Plus cream and a basic standard treatment (basic therapy) of AD according to European Guidelines in pediatric subjects with mild to moderate AD.
SAMPLE SIZE Two hundred (200) subjects with Atopic Dermatitis, of whom at least 50 cases with mild severity Atopic Dermatitis (defined by EASI = Eczema Area and Severity Index = 1.0-7.0 and IGA= Investigator's Global Assessment =2) and 50 cases with moderate severity Atopic Dermatitis (defined by EASI 7.1-21.0 and IGA=3).
TREATMENT SCHEDULE AND METHODS Treatment with the investigational product or the control products will occur twice daily (morning and evening) for 8 weeks after cleansing of the treatment area. After the 8 weeks treatment period, the study subjects will undergo a follow-up visit after 12 weeks following the baseline visit (4 weeks after treatment completion).
Clinical assessments will be performed at baseline (T0), and after 2, 4, 8 and 12 weeks (T2, T4, T8 and T12) by means of a daily diary as a reminder.
Primary endpoint: statistically significant improvement of the EASI between T0 and T8 (p<0.05) in the treatment arm (LimpiAD 2.5% Plus cream ) as compared to the Vehicle of LimpiAD 2.5% Plus cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group LimpiAD | Experimental | Device: LimpiAD 2,5% plus creamLimpiAD 2,5% plus cream to be applied twice a day (morning and evening) for 8 weeks |
| Control group Vehicle of LimpiAD | Active comparator | Other: VehicleVehicle of LimpiAD 2,5% plus cream to be applied twice a day (morning and evening) for 8 weeks. |
| Control group Emollient | Active comparator | Other: EmollientEmollient standard cream to be applied twice a day (morning and evening) for 8 weeks. |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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:
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LimpiAD 2,5% plus creamA 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 | Device | Treatment group LimpiAD |
| VehicleVehicle of LimpiAD 2.5 % plus cream 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 but without the HAc-40 component. | Other | Control group Vehicle of LimpiAD |
| EmollientStandard 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. | Other | Control group Emollient |
Primary outcome
Change in Eczema Area and Severity Index (EASI)
Time frame: Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
The change shall be calculated by comparing the baseline value (T0) with the 2 weeks (T4), 4 weeks (T4) and 8 weeks (T8) values of LimpiAD 2.5% Plus cream versus the Vehicle of LimpiAD 2.5% Plus cream in terms of: - score reduction detected (total EASI score) INTERPRET EASI: Clear 0; Almost clear 0.1-1.0 ; Mild 1.1-7.0 ; Moderate 7.1-21.0 ; Severe 21.1-50.0; Very severe 50.1-72.0
6 secondary outcomes
Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis
Time frame: Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Eczema Area and Severity Index (EASI) Change
Time frame: Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Change in pruritus
Time frame: Baseline (T0), 4 weeks (T4) and 8 weeks (T8)
Change in sleep
Time frame: Baseline (T0), 4 weeks (T4) and 8 weeks (T8)
Change in extension and signs intensity of the target areas,
Time frame: Baseline (T0),2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Children's Dermatology Life Quality Index (CDLQI) questionnaire
Time frame: Baseline (T0),2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruggiero Giuseppe, MD principal investigator
ASL Salerno
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LimpiAD 2,5% plus cream and Emollient in people with Atopic Dermatitis, run by Aileens Pharma SRL at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Alfio Cutuli, PharmD (3899407083 ext. +39, marcocutui@aileenspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Eczema Area and Severity Index (EASI) (time frame: Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.