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ClinicalTrials.gov ID

NCT07295678

Lead Sponsor

CEN BiotechINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

44Estimated

Last Update Posted

Dec 26, 2025Actual

Start Date

Jan 5, 2026Estimated

Primary Completion Date

Jul 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

Official Title

Open-label Clinical Investigation to Evaluate the Performance and Safety of Medical Device "Urgo Filmocream Eczema" in Association With Dermocorticoids on Atopic Dermatitis Lesions

Brief Summary

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.

Detailed Description

This study has two parts.

1. Treatment phase (up to 30 days):

• For the lesions treated with the combination of both products, URGO FilmoCream Eczema is applied at least twice a day, in the morning and evening. In the evening, it is applied after topical corticosteroid (Desonide 0.1% or, if needed, betamethasone 0.05%).
• For the lesion treated with topical corticosteroid only: treatment starts with Desonide 0.1% and may switch to betamethasone 0.05% if needed.

This part lasts until the skin is fully healed.

• Atopic Dermatitis

• Treatment period with dermocorticoid alone
• Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid
• Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid
• Follow-up period after dermocorticoid treatment alone

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Male or female subject.
2. Aged 18 or more.
3. With mild to moderate atopic dermatitis based on the Investigator's Global Assessment for Atopic Dermatitis (IGA-AD).
4. Presence of two comparable atopic dermatitis lesions requiring treatment with topical corticosteroids, located at anatomically distant sites.
5. Having given her/his informed, written consent,
6. 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.
7. Psychologically capable of understanding the study information and providing informed consent.
8. Affiliated to a health social security system.
9. 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.

Exclusion Criteria:

1. Subject currently participating in another clinical study that may interfere with the assessments of the present study, according to the investigator's judgment.
2. 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.
3. Subject who, in the investigator's judgment, is unlikely to comply with study-related constraints and requirements.
4. Subject who has forfeited his/her freedom by administrative or legal decision, or who is under legal guardianship.
5. Female subject of childbearing potential who is pregnant, breastfeeding, or planning to become pregnant during the study.
6. Subject with a known contraindication to topical corticosteroids, such as hypersensitivity to desonide, betamethasone, or any component of the prescribed corticosteroid formulations.
7. 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.
8. Subject with a skin disease, abnormality, or dermatological condition in the study area that may interfere with study assessments.
9. 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.
10. 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.
11. 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

CEN BiotechINDUSTRY

Collaborators

Eurofins Dermscan PharmascanINDUSTRY

URGO Recherche, Innovation et DéveloppementUNKNOWN

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