Status:
RECRUITING
Comparison of LimpiAD Cream 2.5% Plus Versus Its Vehicle and and a Basic Emollient in Patients With Atopic Dermatitis
Lead Sponsor:
Aileens Pharma SRL
Collaborating Sponsors:
Advice Pharma Group srl
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6-16 years
Phase:
NA
Brief 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 v...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05984420
Start Date
April 21 2022
End Date
December 31 2024
Last Update
February 6 2024
Active Locations (5)
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1
Dr. Chianese Pierluigi
Castellammare di Stabia, Napoli, Italy, 80053
2
Dr. Carlomagno Francesco
Nola, Napoli, Italy, 80035
3
Dr. D'Onofrio Antonietta
Pomigliano d'Arco, Napoli, Italy, 80038
4
Dr. Giuseppe Ruggiero
Battipaglia, Salerno, Italy, 84091