CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS

Launched by COSMETIQUE ACTIVE INTERNATIONAL · Mar 13, 2023

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Women or men, from 3 years old, being 50% children (≥3 years old ≤ 11 years and 11 months) and 50% adults;
• • All phototypes (a good balance between the phototypes is not mandatory, but all phototypes should be included);
• • Diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features);
• • Subject with mild atopic dermatitis present for at least 6 months before inclusion (SCORAD at inclusion \< 25);
• • Subjects that have an unchanged AD routine for at least 3 months, including to systematic use of topical or systemic antihistamines, topical or systemic corticoid, cyclosporin A and other immunosuppressant.
• • Subject able to use the study product at least once a day during all study.
• • Subject agreeing not to change their lifestyle during the study period (overbathing, being exposed to intense stress as change job, do a fast diet to loose weight...);
• • Subject agreeing to use only the study product and no other topical treatment for the duration of the study (usual topical or oral treatment for AD is allowed);
• • Subject capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations;
• • Subject available to follow the study;
• • Subject agreeing to participate and having signed the informed consent;
• • Subject available to be contacted by phone throughout the study.
• Exclusion Criteria:
• • Breastfeeding, pregnant;
• • Subject presenting with another dermatological condition that could interfere with clinical evaluation;
• • Subject presenting a previous history of allergy to cosmetic products;
• • Subject having received any systemic treatment, including PUVA therapy for atopic dermatitis in the month prior to Day 0;
• • Subject having received phototherapy within 2 weeks before the first visit;
• • Subject who intend to excessively expose themselves to the sun during the study;
• • Subject known allergy to any component of the tested product (subjects will be asked if they have allergies to any ingredients and will be checked in the list if it is contained in the IP);
• • Subject who have used any experimental treatment within 2 weeks before the first visit;
• • Subject not presenting with the conditions needed to comply with the protocol;
• • Subject unable to give their informed consent;
• • Subject not available to follow the study in its entirety.