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The therapeutic cornerstone for mild to moderate forms of atopic dermatitis (AD) relies on the combination of topical corticosteroids and emollients. However, the daily application of emollients can be burdensome, leading to poor adherence, treatment fatigue, and therapeutic failure, often prompting a switch in emollient products.
Emollients therefore represent a true therapeutic challenge. They also raise economic concerns, as they are not reimbursed by national health insurance, unlike topical corticosteroids. This results in an out-of-pocket expense for patients, adding a significant financial burden in the context of this chronic skin condition.
Laboratoires Gilbert have developed and patented an active ingredient derived from seawater (Active Oligo Skin), formulated and produced at their pharmaceutical site in Hérouville Saint Clair. This active compound has shown promising in vitro and preclinical results in modulating inflammatory mechanisms involved in sensitive and atopic skin.
The objective of this clinical trial is to compare the efficacy of Laboratoires Gilbert's patented emollient balm (Relipid+) with a reference emollient balm considered the "gold standard" and most frequently prescribed on the market (Lipikar Baume AP+M, La Roche-Posay) for atopic dermatitis. The hypothesis is that the test balm will be at least as effective as the gold standard (non-inferiority) in clinical terms, with an added benefit on microbiome diversity-an emerging and critical issue in the management of atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bras Lipikar AP+M (La Roche Posay) | Active Comparator |
| |
| Bras baume RELIPID+ (Laboratoires Gilbert) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baume Relipid+ | Other | Application of daily emollient |
|
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD measurment | SCORAD (Scoring Atopic Dermatitis) : from 0 up to 103 | Day 0; Day 7; Day 28; Day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| DLQI (Quality of life) | DLQI questionnaire, scoring to 0 up to 30 | Day 7 and Day 14 |
| Itch NRS scale (Itch Numeric Rating Scale) | Itch Numeric Rating Scale from 0 to 10 |
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Inclusion Criteria:
Patients aged 6 months to 70 years with mild to moderate atopic dermatitis (SCORAD < 40)
Time to treatment initiation < 72 hours between initial assessment and balm application
Affiliated with the French national health insurance system and French-speaking
Written informed consent must be obtained
Exclusion Criteria:
Patients who decline participation
Patients under legal guardianship, curatorship, legal protection, or judicial safeguard
Patients with a SCORAD indicating the need for systemic therapy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen Normandie | Caen | Normandy | France |
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| Day 4 and Day 14 |
| Use of topical steroids | Amount of topical steroids used | Day 70 at the end of the study |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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