URGO FilmoCream Eczema + Dermocorticoids in Atopic Dermatitis

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

Overview

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.

Interventions

• 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.
• 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
• 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.
• 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.

Primary outcome measures

• Change from baseline in local SCORAD Index at end of treatment [Time frame: up to 30 days]
• Change from baseline in local SCORAD Index at 3 days [Time frame: 3 days]
• Change from baseline in local SCORAD Index at 7 days [Time frame: 7 days]

Secondary outcome measures (8)

• Change from baseline in pruritus severity at 3 days [Time frame: 3 days]
• Change from baseline in pruritus severity at 7 days [Time frame: 7 days]
• Change from baseline in pruritus severity at end of treatment [Time frame: up to 30 days]
• Time to complete lesion resolution [Time frame: 30 days]
• Dermocorticoid use during the treatment period [Time frame: 30 days]
• Relapse rate after initial treatment [Time frame: 28 days]
• Time to the first relapse after initial treatment [Time frame: 28 days]
• Dermocorticoid use in relapsed lesions [Time frame: 28 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Poland · 2 centers

• Eurofins Dermscan Poland — Gdansk
• Private Practice — Malbork

Identifiers

NCT: NCT07295678 · 22E4474

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗