URGO FilmoCream Eczema + Dermocorticoids in Atopic Dermatitis

NCT07295678 | Not Yet Recruiting

• 1 other identifier: 22E4474
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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. 1.Does URGO FilmoCream Eczema improve symptom relief of atopic dermatitis when used alongside standard topical corticosteroid treatment?
2. 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.

Conditions

Atopic Dermatitis

Keywords

eczema lesions; adjuvant treatment to dermocorticoids; URGO FilmoCream Eczema

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Change from baseline in pruritus severity at 3 days

  3 days

• Change from baseline in pruritus severity at 7 days

  7 days

• Change from baseline in pruritus severity at end of treatment

  up to 30 days

• Time to complete lesion resolution

  30 days

• Dermocorticoid use during the treatment period

  30 days

Other Outcomes (10)

• Change in skin hydration at 3 days

  3 days

• Change in skin hydration at 7 days

  7 days

• Change in skin hydration at the end of the treatment

  up to 30 days

Study Arms (2)

URGO FilmoCream Eczema plus dermocorticoid

EXPERIMENTAL

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; Combination Product: Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid

Dermocorticoid alone

ACTIVE COMPARATOR

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; Drug: Follow-up period after dermocorticoid treatment alone

Interventions

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.

URGO FilmoCream Eczema plus dermocorticoid

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.

Dermocorticoid alone

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.

URGO FilmoCream Eczema plus dermocorticoid

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.

Dermocorticoid alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CEN Biotech: lead
• Eurofins Dermscan Pharmascan: collaborator
• URGO Recherche, Innovation et Développement: collaborator

Study Sites (2)

Eurofins Dermscan Poland

Gdansk, Poland

Location

Private Practice

Malbork, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ewa Karamon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christelle FOUCHER

CONTACT

+33380447049; c.foucher@fr.urgo.com

Joanna PAŁUBICKA

CONTACT

+48 58 732 02 99; JPA@dermscan.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluation of the lesions is carried out by a blind observer who is unaware of the treatment allocation of the lesions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this intra-individual randomized design, each subject will have two comparable AD lesions, each randomized to receive either URGO FilmoCream Eczema + Desonide 0.1% cream or Desonide 0.1% cream alone.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 19, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)