An interventional study of Baume Relipid+ in Atopic Dermatitis and Emollients, sponsored by University Hospital, Caen. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Treatment
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 86 is close to the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.
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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 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Baume Relipid+
Other: Baume Relipid+
Application of daily emollient
SCORAD measurment
SCORAD (Scoring Atopic Dermatitis) : from 0 up to 103
Time frame: Day 0; Day 7; Day 28; Day 70
DLQI (Quality of life)
DLQI questionnaire, scoring to 0 up to 30
Time frame: Day 7 and Day 14
Itch NRS scale (Itch Numeric Rating Scale)
Itch Numeric Rating Scale from 0 to 10
Time frame: Day 4 and Day 14
Use of topical steroids
Amount of topical steroids used
Time frame: Day 70 at the end of the study
Plan to share: No
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