Double-blind, Randomized, Non-inferiority Trial in Atopic Dermatitis: Comparison of Lipikar Balm and Relipid+ Balm in the Treatment of Mild to Moderate Atopic Dermatitis in Children and Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Baume Relipid+.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis, Emollients. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
AIMSI Trial : Double-blind, Randomized, Non-inferiority Trial in Atopic Dermatitis: Comparison of Lipikar Balm and Relipid+ Balm in the Treatment of Mild to Moderate Atopic Dermatitis in Children and Adults
Overview
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.
Interventions
- Other Baume Relipid+
Application of daily emollient
Primary outcome measures
- SCORAD measurment [Time frame: Day 0; Day 7; Day 28; Day 70]
Secondary outcome measures (3)
- DLQI (Quality of life) [Time frame: Day 7 and Day 14]
- Itch NRS scale (Itch Numeric Rating Scale) [Time frame: Day 4 and Day 14]
- Use of topical steroids [Time frame: Day 70 at the end of the study]
Eligibility criteria
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
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
- Double blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Caen Normandie — Caen
Identifiers
NCT: NCT07358000 · 2024-A02369-38