URGO FilmoCream Eczema + Dermocorticoids in Atopic Dermatitis (GERONIMO)

CEN Biotech

Status: Not yet enrolling

Conditions: Atopic Dermatitis

Treatments: 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; Combination Product: Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07295678

22E4474

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

URGO FilmoCream Eczema plus dermocorticoid

Experimental group

Description:

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.

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

Dermocorticoid alone

Active Comparator group

Description:

During the treatment period, a dermocorticoid is used. During the follow-up phase, dermocorticoid is applied only in case of relapse.

Treatment:

Drug: Follow-up period after dermocorticoid treatment alone

Drug: Treatment period with dermocorticoid alone