Status:
RECRUITING
Comparison of LimpiAD Cream 2.5% Plus Versus Vehicle and an Emollient in Patients With Atopic Dermatitis
Lead Sponsor:
Aileens Pharma SRL
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-16 years
Phase:
NA
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05971355
Start Date
March 10 2021
End Date
December 31 2024
Last Update
February 6 2024
Active Locations (5)
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1
University of Bari Hospital
Bari, Italy
2
University of Modena e Reggio Emilia
Modena, Italy
3
University of Naples Hospital
Naples, Italy
4
S. Gallicano Hospital
Rome, Italy