Comparative Clinical Trial Between LimpiAD 2.5% Plus Cream, Its Vehicle and a Basic Emollient in Atopic Dermatitis in Paediatric Age

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 16
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Italy
Dr. Giuseppe Ruggiero
RECRUITING
Battipaglia
Dr. Chianese Pierluigi
RECRUITING
Castellammare Di Stabia
Dr. Carlomagno Francesco
RECRUITING
Nola
Dr. D'Onofrio Antonietta
NOT_YET_RECRUITING
Pomigliano D'arco
Dr. Occhinegro Aurelio
RECRUITING
Salerno
Contact Information
Primary
Marco Alfio Cutuli, PharmD
marcocutui@aileenspharma.com
3899407083
Backup
Sonia Longo Sormani, M.Sc.
sonia.longo@aileenspharma.com
3486556591
Time Frame
Start Date: 2022-04-21
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Treatment group LimpiAD
LimpiAD 2,5% plus cream to be applied twice a day (morning and evening) for 8 weeks
Active_comparator: Control group Vehicle of LimpiAD
Vehicle of LimpiAD 2,5% plus cream to be applied twice a day (morning and evening) for 8 weeks.
Active_comparator: Control group Emollient
Emollient standard cream to be applied twice a day (morning and evening) for 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: Aileens Pharma SRL
Collaborators: Advice Pharma Group srl

This content was sourced from clinicaltrials.gov