NCT07295678Not yet recruiting
URGO FilmoCream Eczema + Dermocorticoids in Atopic Dermatitis
Open-label Clinical Investigation to Evaluate the Performance and Safety of Medical Device "Urgo Filmocream Eczema" in Association With Dermocorticoids on Atopic Dermatitis Lesions
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
The goal of this clinical study is to determine whether URGO FilmoCream Eczema is effective as a non-steroidal treatment to relieve symptoms of atopic dermatitis. It also aims to evaluate the cream's ability to moisturize, soothe irritation, protect the skin, and promote healing of eczema lesions. The main questions the study seeks to answer are: 1. Does URGO FilmoCream Eczema improve symptom relief of atopic dermatitis when used alongside standard topical corticosteroid treatment? 2. How do eczema lesions treated with topical corticosteroids alone progress and heal compared to those treated with topical corticosteroids plus URGO FilmoCream Eczema? To investigate this, patients with at least two similar eczema lesions are enrolled. One lesion is treated with topical corticosteroids alone, while the other is treated with topical corticosteroids plus URGO FilmoCream Eczema. The progression of both lesions is monitored throughout treatment, until healing, and for 28 days after the last application of topical corticosteroids.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 25 Nov 2025
- Start date
- 5 Jan 2026
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- CEN Biotech
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07295678
What you commit to
- Study type: Interventional
- Planned participants: 44
- From 5 Jan 2026 to the primary completion date, 30 Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any systemic treatment, including oral corticosteroids, that is incompatible with the study or likely to interfere with study assessments according to the investigator, administered in the weeks prior to the inclusion visit, ongoing, or planned to start during the study.
- Any topical treatment on the tested area that is incompatible with the study or likely to interfere with study assessments according to the investigator, administered in the weeks prior to the inclusion visit.
Other illness
- Subject unable to understand the information provided - including study procedures - due to linguistic or psychiatric reasons, and therefore unable to give written informed consent or to complete the study diary as required.
- Subject with a known contraindication to topical corticosteroids, such as hypersensitivity to desonide, betamethasone, or any component of the prescribed corticosteroid formulations.
- Subject with broken or ulcerated skin, acne, rosacea (including perioral dermatitis), any untreated or active skin infection (viral, bacterial, or fungal), or skin thinning at the application sites.
- Subject with a skin disease, abnormality, or dermatological condition in the study area that may interfere with study assessments.
- Subject with acute, chronic, or progressive disease, or relevant medical history, considered by the investigator to be hazardous for the subject, incompatible with the study, or likely to interfere with study assessments.
Other
- Subject currently participating in another clinical study that may interfere with the assessments of the present study, according to the investigator's judgment.
- Subject who, in the investigator's judgment, is unlikely to comply with study-related constraints and requirements.
- Subject who has forfeited his/her freedom by administrative or legal decision, or who is under legal guardianship.
- Female subject of childbearing potential who is pregnant, breastfeeding, or planning to become pregnant during the study.
Who the study is looking for
- Male or female subject.
- Aged 18 or more.
- With mild to moderate atopic dermatitis based on the Investigator's Global Assessment for Atopic Dermatitis (IGA-AD).
- Presence of two comparable atopic dermatitis lesions requiring treatment with topical corticosteroids, located at anatomically distant sites.
- Having given her/his informed, written consent,
- Cooperative, fully informed of the treatment procedures, and aware of the importance and schedule of follow-up visits, ensuring expected full adherence to the study protocol.
- Psychologically capable of understanding the study information and providing informed consent.
- Affiliated to a health social security system.
- Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end and must have a negative urine pregnancy test before the first treatment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eurofins Dermscan Poland Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Private Practice Coordinator of this site? Confirm its status | Malbork | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.