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)

January 20, 2026 updated by: University Hospital, Caen

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Normandy
      • Caen, Normandy, France
        • CHU Caen Normandie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bras Lipikar AP+M (La Roche Posay)
Other: Baume Relipid+
Application of daily emollient
Experimental: Bras baume RELIPID+ (Laboratoires Gilbert)
Other: Baume Relipid+
Application of daily emollient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCORAD measurment
Time Frame: Day 0; Day 7; Day 28; Day 70
SCORAD (Scoring Atopic Dermatitis) : from 0 up to 103
Day 0; Day 7; Day 28; Day 70

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLQI (Quality of life)
Time Frame: Day 7 and Day 14
DLQI questionnaire, scoring to 0 up to 30
Day 7 and Day 14
Itch NRS scale (Itch Numeric Rating Scale)
Time Frame: Day 4 and Day 14
Itch Numeric Rating Scale from 0 to 10
Day 4 and Day 14
Use of topical steroids
Time Frame: Day 70 at the end of the study
Amount of topical steroids used
Day 70 at the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 19, 2025

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A02369-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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