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

Sponsor
University Hospital, Caen
Study ID
NCT07358000
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baume Relipid+ — OTHER
    Application of daily emollient

Study Details

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.

Key Dates

First listed
Jan 22, 2026
Start date
Mar 30, 2026
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bras Lipikar AP+M (La Roche Posay)
  • Experimental: Bras baume RELIPID+ (Laboratoires Gilbert)

Primary Outcome Measure

SCORAD measurment [ Time Frame: Day 0; Day 7; Day 28; Day 70 ]

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