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 (AIMSI)

Caen University Hospital

Status: Begins enrollment in 1 month

Conditions: Atopic Dermatitis; Emollients

Treatments: Other: Baume Relipid+

Study type: Interventional

Funder types: Other

Identifiers

NCT07358000

2024-A02369-38

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

Bras Lipikar AP+M (La Roche Posay)

Active Comparator group

Treatment:

Other: Baume Relipid+

Bras baume RELIPID+ (Laboratoires Gilbert)

Experimental group

Treatment:

Other: Baume Relipid+