URGO FilmoCream Eczema + Dermocorticoids in Atopic Dermatitis (GERONIMO)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Combination product: Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid; Combination product: Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid; Drug: Treatment period with dermocorticoid alone; Drug: Follow-up period after dermocorticoid treatment alone

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christelle FOUCHER; Phone Number: +33380447049; Email: c.foucher@fr.urgo.com
• Study Contact Backup: Name: Joanna PAŁUBICKA; Phone Number: +48 58 732 02 99; Email: JPA@dermscan.pl

Study Locations

• Poland
  • Gdansk, Poland
    • Eurofins Dermscan Poland
    • Contact: Joanna PAŁUBICKA; Phone Number: +48 58 732 02 99; Email: JPA@dermscan.pl
    • Contact: Justyna Sowińska, MD; Phone Number: +48 58 732 02 90; Email: jso@dermscan.pl
    • Principal Investigator: Justyna Sowińska, MD
    • Principal Investigator: Ewa Karamon, MD
  • Malbork, Poland
    • Private Practice
    • Principal Investigator: Ewa Karamon, MD
    • Contact: Ewa Karamon, MD; Phone Number: +48 603 977 986; Email: ewaczek20@wp.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: URGO FilmoCream Eczema plus dermocorticoid; During the treatment period, URGO FilmoCream Eczema is used alone in the morning and in combination with a topical corticosteroid in the evening. During the follow-up phase, it is applied only in case of relapse, twice daily. If the lesion does not improve or worsens, it must be combined with a dermocorticoid in the evening, as during the treatment period.	Combination product: Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid; Until lesion resolution, for a maximum of 30 consecutive days URGO FilmoCream Eczema is applied at least twice daily (morning and evening) in a thin layer over the entire surface of the selected lesion, extending 1 cm beyond the edges, and left to dry for about 30 seconds to form a protective film. Reapplication is allowed if the film is disturbed (e.g., due to water exposure), with a maximum of 20 pump pressures per day. In the evening, it is applied after the dermocorticoid - desonide 0.1%, or betamethasone 0.05% in case treatment escalation is required.; Combination product: Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid; During the 28-day follow-up period, in case of relapse, URGO FilmoCream Eczema is reapplied twice daily (morning and evening). If there is no improvement or worsening, the combined treatment must be reinitiated under the same conditions as during the treatment period.
Active Comparator: Dermocorticoid alone; During the treatment period, a dermocorticoid is used. During the follow-up phase, dermocorticoid is applied only in case of relapse.	Drug: Treatment period with dermocorticoid alone; Until lesion resolution, for a maximum of 30 consecutive days Treatment with dermocorticoids - desonide 0.1%, or betamethasone 0.05% in case treatment escalation is required.; Drug: Follow-up period after dermocorticoid treatment alone; During the 28-day follow-up period, in case of relapse, start with desonide 0.1%, escalate to betamethasone 0.05% if necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in local SCORAD Index at end of treatment	The local SCORAD Index includes the intensity part of SCORAD (SCORing Atopic Dermatitis) index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation. The variations from baseline in the Local SCORAD Index are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	up to 30 days
Change from baseline in local SCORAD Index at 3 days	The variations from baseline at 3 days in the Local SCORAD (SCORing Atopic Dermatitis) Index are compared between lesions treated with the combination therapy and those treated with dermocorticoid alone. The local SCORAD Index includes the intensity part of SCORAD index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation.	3 days
Change from baseline in local SCORAD Index at 7 days	The variations from baseline at 7 days in the Local SCORAD (SCORing Atopic Dermatitis) Index are compared between lesions treated with the combination therapy and those treated with dermocorticoid alone. The local SCORAD Index includes the intensity part of SCORAD index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pruritus severity at 3 days	Severity is assessed using a visual analog scale (0-10 VAS), where 0 means no itch and 10 the worst imaginable itch. The variations from baseline in 0-10 VAS values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	3 days
Change from baseline in pruritus severity at 7 days	Severity is assessed using a visual analog scale (0-10 VAS), where 0 means no itch and 10 the worst imaginable itch. The variations from baseline in 0-10 VAS values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	7 days
Change from baseline in pruritus severity at end of treatment	Severity is assessed using a visual analog scale (0-10 VAS), where 0 means no itch and 10 the worst imaginable itch. The variations from baseline in 0-10 VAS values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	up to 30 days
Time to complete lesion resolution	Complete resolution is subjectively assessed by the investigator. The time to complete resolution is compared between the two lesion treatments using Kaplan-Meier survival analysis, with differences assessed by the log-rank test.	30 days
Dermocorticoid use during the treatment period	The average number of applications of desonide 0.1% and Betamethasone 0.05% will be compared between lesions treated with combination therapy and those treated with dermocorticoid alone.	30 days
Relapse rate after initial treatment	Proportions of lesions that relapse after having achieved resolution during the treatment period are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	28 days
Time to the first relapse after initial treatment	The time to the first relapse after initial treatment is compared between the two lesion treatments using Kaplan-Meier survival analysis, with differences assessed by the log-rank test	28 days
Dermocorticoid use in relapsed lesions	The average number of applications of desonide 0.1% and Betamethasone 0.05% will be compared between relapsed lesions initially treated with the combination therapy and those initially treated with dermocorticoid alone.	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skin hydration at 3 days	Skin hydration is assessed using the Corneometer® CM 825 (COURAGE & KHAZAKA), which measures the electrical capacitance of the skin surface. This parameter reflects the moisture level of the skin, providing an estimate of its hydration status. The results (hydration index) are expressed in arbitrary units (a.u.). The variations from baseline in hydration index values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	3 days
Change in skin hydration at 7 days	Skin hydration is assessed using the Corneometer® CM 825 (COURAGE & KHAZAKA), which measures the electrical capacitance of the skin surface. This parameter reflects the moisture level of the skin, providing an estimate of its hydration status. The results (hydration index) are expressed in arbitrary units (a.u.). The variations from baseline in hydration index values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	7 days
Change in skin hydration at the end of the treatment	Skin hydration is assessed using the Corneometer® CM 825 (COURAGE & KHAZAKA), which measures the electrical capacitance of the skin surface. This parameter reflects the moisture level of the skin, providing an estimate of its hydration status. The results (hydration index) are expressed in arbitrary units (a.u.). The variations from baseline in hydration index values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	up to 30 days
Change in skin barrier integrity at 3 days	Transepidermal Water Loss (TEWL) is measured using a Tewameter TM 300®. And expressed in grams per hour per square meter (g/h/m²). It quantifies the amount of water evaporating from the skin surface over one hour per unit area, providing an indicator of skin barrier function. The variations from baseline in TEWL values are compared between lesions treated with combination therapy and lesions treated with dermocorticoid alone.	3 days
Change in skin barrier integrity at 7 days	Transepidermal Water Loss (TEWL) is measured using a Tewameter TM 300®. And expressed in grams per hour per square meter (g/h/m²). It quantifies the amount of water evaporating from the skin surface over one hour per unit area, providing an indicator of skin barrier function. The variations from baseline in TEWL values are compared between lesions treated with combination therapy and lesions treated with dermocorticoid alone.	7 days
Change in skin barrier integrity at the end of the treatment	Transepidermal Water Loss (TEWL) is measured using a Tewameter TM 300®. And expressed in grams per hour per square meter (g/h/m²). It quantifies the amount of water evaporating from the skin surface over one hour per unit area, providing an indicator of skin barrier function. The variations from baseline in TEWL values are compared between lesions treated with combination therapy and lesions treated with dermocorticoid alone.	up to 30 days
Local tolerance to the treatments at Day 3	Based on patient's reported clinical signs (pain, burning sensation, itching, discomfort or other symptoms) following application of the assigned treatment to the lesion, the investigator subjectively assesses tolerance using a 0-3 scale where 0= Poor tolerance at application, 1= Moderate tolerance at application, 2= Good tolerance at application, 3= Very good tolerance at application. Scores are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	3 days
Local tolerance to the treatments at Day 7	Based on patient's reported clinical signs (pain, burning sensation, itching, discomfort or other symptoms) following application of the assigned treatment to the lesion, the investigator subjectively assesses tolerance using a 0-3 scale where 0= Poor tolerance at application, 1= Moderate tolerance at application, 2= Good tolerance at application, 3= Very good tolerance at application. Scores are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	7 days
Local tolerance to the treatments at the end of the treatment	Based on patient's reported clinical signs (pain, burning sensation, itching, discomfort or other symptoms) following application of the assigned treatment to the lesion, the investigator subjectively assesses tolerance using a 0-3 scale where 0= Poor tolerance at application, 1= Moderate tolerance at application, 2= Good tolerance at application, 3= Very good tolerance at application. Scores are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	up to 28 days
Occurrence of adverse events during the study	Adverse events are described using MedDRA , whether they occur during the treatment period or during the follow-up period. Where appropriate, the frequency of treatment adverse effects is compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.	up to 58 days

Collaborators and Investigators

• Sponsor: CEN Biotech
• Collaborators: Eurofins Dermscan Pharmascan; URGO Recherche, Innovation et Développement
• Investigators: Principal Investigator: Ewa Karamon

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Estimated): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: eczema lesions; adjuvant treatment to dermocorticoids; URGO FilmoCream Eczema
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: 22E4474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient data is not anonymized. To comply with European regulations, patients are informed that no sharing of IPD is planned in order to protect their personal data. Only aggregated data can be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No