Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis.
NCT ID: NCT06756438
Last Updated: 2025-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
88 participants
INTERVENTIONAL
2024-09-02
2025-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this study is to assess the efficacy of a product for atopic skin versus a placebo. Primary objectives include assessing the number, the delay and severity of recurrences of atopic dermatitis (measured by the SCORAD score), and the evolution of symptoms such as dryness and pruritus. Secondary objectives include quality of life and quality of sleep and skin acceptability.
The study protocol is a multicenter, double-blind, randomized clinical trial, in which participants receive either the study product or a placebo, while continuing their topical corticosteroid treatment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Efficacy of a Dermocosmetic Product RT00401-GO0046 on Atopic Dermititis Severity in Subjects With Mild Atopic Dermatitis Versus Placebo
NCT06763939
Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products In Atopic Dermatitis
NCT06930365
A Study to Test the Effect of 2 Different Doses of Topical GW870086X on Atopic Dermatitis Also Including a Postive Control and a Placebo
NCT01299610
Evaluating Results of Regularly Applied Emollient - Spray in Atopic Dermatitis Therapy
NCT02763722
The Effects of a Botanical Moisturizer and an Unscented Soap on Eczema and Itch
NCT06804070
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Amr 1: Study product
Product 1: Study product, Emollient. Face and body
Study product
Anti-itching, anti-replapse and repairing treatment. Emollient.
Arm 2: Placebo
Product 2: Placebo, Emollient. face and body
Placebo
Emollient
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Study product
Anti-itching, anti-replapse and repairing treatment. Emollient.
Placebo
Emollient
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
3 Months
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NAOS Les Laboratoires
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
EUROFINS
Gdansk, Poméranie, Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC2024PSaib+PL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.