Evaluating a Dermocosmetic Product for Atopic Dermatitis
Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis - Study Vs Placebo -- Use Test Under Dermatological Control -
This study is testing a new skin product to see if it can help children with atopic dermatitis feel better and have fewer flare-ups compared to a placebo while they continue their regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 3 Months to 12 Years |
| Sex | All |
| Sponsor | NAOS Les Laboratoires Industry-sponsored |
| Locations | 1 site (Gdansk, Poméranie) |
| Trial ID | NCT06756438 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and skin acceptability of a dermocosmetic product in children suffering from atopic dermatitis compared to a placebo. It is a multicenter, double-blind, randomized clinical trial where participants will receive either the study product or a placebo while continuing their topical corticosteroid treatment. The primary objectives include measuring the frequency, timing, and severity of eczema flare-ups, as well as assessing symptoms like dryness and itching. Secondary objectives focus on the quality of life and sleep of the participants.
Who should consider this trial
Good fit: Ideal candidates include children aged 3 months to 12 years with atopic dermatitis who have experienced multiple flare-ups in the past six months.
Not a fit: Patients who do not have atopic dermatitis or those who are not experiencing current flare-ups may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective dermocosmetic option to improve skin condition and quality of life for children with atopic dermatitis.
How similar studies have performed: Other studies have shown promise in using dermocosmetic products for skin conditions, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Gdansk, Poméranie
- Eurofins — Gdansk, Poméranie, Poland (Recruiting)
Study contacts
- Study coordinator: Wioleta MALINOWWSKA-KAKOL
- Email: wioleta.malinowska-kakol@cpt.eurofinseu.com
- Phone: 587320290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.