Atopic DermatitisNCT05971355
Comparison of LimpiAD Cream 2.5% Plus Versus Vehicle and an Emollient in Patients With Atopic Dermatitis
A study testing LimpiAD cream 2,5% plus and Emollient in people with Atopic Dermatitis, run by Aileens Pharma SRL at 5 sites in Italy.
Trial summary
The purpose of this randomized clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5% Plus cream and a standard emollient used as neutral control, which represents the basic standard treatment (basic therapy)… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LimpiAD cream 2,5% plus 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
- 10 Mar 2021to 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- 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).
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;
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites, 4 recruiting
- Recruiting
University of Bari Hospital
Bari
Domenico Bonamonte, Prof, domenico.bonamonte@uniba.it
- Recruiting
University of Modena e Reggio Emilia
Modena
Francesca Farnetani, Prof, francesca.farnetani@unimore.it
- Recruiting
University of Naples Hospital
Naples
Giuseppe Argenziano, Prof, g.argenziano@gmail.com
- Terminated
S. Gallicano Hospital
Rome
- Recruiting
University Rome La Sapienza (Hospital Umberto I)
Rome
Giovanni Pellacani, Prof, pellacani.giovanni@gmail.com
About this study
Official title: Clinical Comparison of LimpiAD Cream 2.5% Plus, Vehicle and an Emollient in Pediatric Patients With Atopic Dermatitis
The purpose of this randomized clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5% Plus cream and a standard emollient used as neutral control, which represents the basic standard treatment (basic therapy) of AD according to European Guidelines in pediatric subjects with mild to moderate Atopic Dermatitis.
Read the detailed description
The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5% Plus cream and a standard emollient used as neutral control, which represents the basic standard treatment (basic therapy) of AD according to European Guidelines in pediatric subjects with mild to moderate Atopic Dermatitis.
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
- Atopic Dermatitis
- Being tested
- LimpiAD cream 2,5% plus, Vehicle, Emollient
- Keywords
- Atopic dermatitis, topical treatment, pediatric atopic dermatitis, atopic eczema, LimpiAD
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LimpiAD cream 2,5% plusDevice
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 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.
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 | Experimental | LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks. Receives: Device: LimpiAD cream 2,5% plus |
| Control group | Active comparator | Vehicle of LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks. Receives: Other: Vehicle |
| Emollient group | Active comparator | Emollient cream to be applied twice a day (morning and evening) for 4 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 corresponding value at 4 weeks (T4) for LimpiAD cream 2,5% Plus versus the Vehicle of LimpiAD cream 2,5% Plus in terms of detected score reduction (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) and 4 weeks (T4)
Secondary outcomes (8)
Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis
The change shall be calculated by comparing the baseline value (T0) with the corresponding values at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment 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) and 4 weeks (T4)
Eczema Area and Severity Index (EASI) Change
The change shall be calculated, by comparing the baseline value (T0) with the corresponding values at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms in terms of:
- % of patients reaching a 50% (EASI50), 75% (EASI75), 90% (EASI90) and 100% (EASI100) reduction in the baseline 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) and 4 weeks (T4)
Change in pruritus at the 4 week (T4)
Change in pruritus at the 4th week (T4): 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 at baseline, in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.
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), 2 weeks (T2) and 4 weeks (T4)
Change in sleep at 4 weeks (T4)
Change in sleep at 4 weeks (T4) intended as 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 cream 2.5% Plus as compared to the other 2 study treatment arms.
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), 2 weeks (T2) and 4 weeks (T4)
Change in extension and signs intensity of the target areas
Change in extension and signs intensity of the target areas, assessed as local Eczema Area and Severity Index (EASI), by separately considering the skin fold area with respect to the fold-free skin area at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms
Measured: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
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) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus 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) and 4 weeks (T4)
Microbial balance
Change in Cutibacterium acne/Staphylococcus ratio on the affected skin in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.
Measured: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
Functional recovery
Functional recovery:
- change in vascularization measured by dynamic OCT (D-OCT) imaging, assessed in a subsample of subjects, in the treatment arm with LimpiAD 2.5% cream Plus as compared to the other 2 study treatment arms.
Measured: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start10 Mar 2021
- 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)
- Responsible party
- Sponsor
- Investigators
- Francesca Farnetani, Prof, Principal investigator, University of Modena e Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971355
- Sponsor's protocol ID
- LAD-09-20
- Status last verified
- Feb 2024
- First submitted
- 27 Apr 2021
- 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
- Clinical Comparison of LimpiAD Cream 2.5% Plus, Vehicle and an Emollient in Pediatric Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05971355
- Acronym / sponsor ID
- LAD-09-20
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, topical treatment, pediatric atopic dermatitis, atopic eczema, LimpiAD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aileens Pharma SRLIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 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 randomized clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5% Plus cream and a standard emollient used as neutral control, which represents the basic standard treatment (basic therapy) of AD according to European Guidelines in pediatric subjects with mild to moderate Atopic Dermatitis.
Detailed description
The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5% Plus cream and a standard emollient used as neutral control, which represents the basic standard treatment (basic therapy) of AD according to European Guidelines in pediatric subjects with mild to moderate Atopic Dermatitis.
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).
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 | Experimental | Device: LimpiAD cream 2,5% plusLimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks. |
| Control group | Active comparator | Other: VehicleVehicle of LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks. |
| Emollient group | Active comparator | Other: EmollientEmollient cream to be applied twice a day (morning and evening) for 4 weeks. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
- Symptoms and signs compatible with a clinical diagnosis of Atopic Dermatitis should be present upon enrollment;
Key exclusion criteria (10 listed)
- 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.
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 cream 2,5% plusA 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 |
| VehicleVehicle 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. | Other | Control group |
| 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 | Emollient group |
Primary outcome
Change in Eczema Area and Severity Index (EASI)
Time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
The change shall be calculated by comparing the baseline value (T0) with the corresponding value at 4 weeks (T4) for LimpiAD cream 2,5% Plus versus the Vehicle of LimpiAD cream 2,5% Plus in terms of detected score reduction (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
8 secondary outcomes
Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis
Time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
Eczema Area and Severity Index (EASI) Change
Time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
Change in pruritus at the 4 week (T4)
Time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
Change in sleep at 4 weeks (T4)
Time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
Change in extension and signs intensity of the target areas
Time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
Children's Dermatology Life Quality Index (CDLQI) questionnaire
Time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
Microbial balance
Time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
Functional recovery
Time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
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.
Francesca Farnetani, Prof principal investigator
University of Modena e Reggio Emilia
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 cream 2,5% plus 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 8 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, M.Sc. (+393899407083, marco.cutuli@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) and 4 weeks (T4)). 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.