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NCT Number: NCT07295678

URGO FilmoCream Eczema + Dermocorticoids in Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurofins Dermscan Poland, Gdansk, Poland

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About this study

This study has two parts.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Subject currently participating in another clinical study that may interfere with the assessments of the present study, according to the investigator's judgment.
  • 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 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.
  • 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.
  • 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.

Treatment and study plan

Treatment period with dermocorticoid alone

Drug

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.

Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid

Combination Product

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.

Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid

Combination Product

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.

Follow-up period after dermocorticoid treatment alone

Drug

During the 28-day follow-up period, in case of relapse, start with desonide 0.1%, escalate to betamethasone 0.05% if necessary.

Primary outcomes

  1. Change from baseline in local SCORAD Index at end of treatment

    Time frame: up to 30 days

    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.

  2. Change from baseline in local SCORAD Index at 3 days

    Time frame: 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. Change from baseline in local SCORAD Index at 7 days

    Time frame: 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.

Secondary outcomes

  1. Change from baseline in pruritus severity at 3 days

    Time frame: 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.

  2. Change from baseline in pruritus severity at 7 days

    Time frame: 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.

  3. Change from baseline in pruritus severity at end of treatment

    Time frame: up to 30 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.

  4. Time to complete lesion resolution

    Time frame: 30 days

    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.

  5. Dermocorticoid use during the treatment period

    Time frame: 30 days

    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.

  6. Relapse rate after initial treatment

    Time frame: 28 days

    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.

  7. Time to the first relapse after initial treatment

    Time frame: 28 days

    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

  8. Dermocorticoid use in relapsed lesions

    Time frame: 28 days

    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.

Other outcomes

  1. Change in skin hydration at 3 days

    Time frame: 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.

  2. Change in skin hydration at 7 days

    Time frame: 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.

  3. Change in skin hydration at the end of the treatment

    Time frame: up to 30 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.

  4. Change in skin barrier integrity at 3 days

    Time frame: 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.

  5. Change in skin barrier integrity at 7 days

    Time frame: 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.

  6. Change in skin barrier integrity at the end of the treatment

    Time frame: up to 30 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. Local tolerance to the treatments at Day 3

    Time frame: 3 days

    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.

  8. Local tolerance to the treatments at Day 7

    Time frame: 7 days

    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.

  9. Local tolerance to the treatments at the end of the treatment

    Time frame: up to 28 days

    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.

  10. Occurrence of adverse events during the study

    Time frame: up to 58 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle FOUCHER

CONTACT

[email protected]

+33380447049

Joanna PAŁUBICKA

CONTACT

[email protected]

+48 58 732 02 99

Sponsors and collaborators

Lead sponsor

CEN Biotech

Industry

Collaborators

  • Eurofins Dermscan Pharmascan
  • URGO Recherche, Innovation et Développement

Registry information

Official study 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

Acronym: GERONIMO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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