Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis.

Launched by NAOS LES LABORATOIRES · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new dermocosmetic product works for treating atopic dermatitis, commonly known as eczema, in children. Atopic dermatitis is a long-lasting skin condition that causes itching and flare-ups, and it can be especially bothersome for kids. The study aims to compare the new product with a placebo (a treatment that doesn't have any active ingredients) to see how many flare-ups occur, how severe they are, and how the product affects symptoms like dryness and itchiness. Researchers will also look at how the treatment impacts the children's quality of life and sleep.

To participate in this study, children aged between 3 months and 12 years who have atopic dermatitis and have experienced at least three flare-ups in the last six months may be eligible. Parents or guardians must give their consent for their child to join, and the child should be healthy apart from having eczema. During the trial, participants will continue using their prescribed corticosteroid treatments while either receiving the new product or the placebo. This is a double-blind study, meaning neither the participants nor the researchers will know who is getting which treatment to ensure unbiased results.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Specific
• • Sex: female and/or male;
• • Age: from 3 months up to 12 years old;
• • Phototype: I to IV;
• • 100% with atopic skin;
• • 100% with sensitive skin;
• • Subject who had at least 3 eczema flares-up of atopic dermatitis during the last 6 months before start of the study, including the crisis observed on D-X.
• • Subject presenting on the visit D-X a flare-up of eczema for which the dermatologist prescribed treatment with topical corticosteroids treatment;
• • Subjects with SCORAD between 15 and 40 on D-X;
• • Subject who do not require medical treatment anymore after using prescribed topical corticosteroids from D-X up to D0 and clinical signs of atopic dermatitis are resolved, to be defined on D0 visit (in case of insufficient healing of inflammatory lesions, the subject continues medical treatment as recommended by the investigator).
• • General
• • Healthy subject;
• • Child whose at least one parent/legal guardian has given freely and expressly her/his informed consent;
• • Child whose at least one parent/legal guardian is willing to adhere to the protocol and study procedures;
• • Polish citizenship.
• Exclusion Criteria:
• • Cutaneous pathology on the study zone other than atopic dermatitis;
• • Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study products, including anti-histaminic treatment (except prescribed dermocorticoids on D-X and in case of flare-up during the study course);
• • Subject having undergone a surgery under general anesthesia within the previous month;
• • Excessive exposure to sunlight or UV-rays within the previous month;
• • Subject enrolled in another clinical trial during the study period (concerns the studied zones);
• • Subjects presenting oozing eczema lesions or any sign of infection on eczema lesions (e.g; pus).