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

NCT07358000 | Recruiting

• 1 other identifier: 2024-A02369-38
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis; Emollients

Outcome Measures

Primary Outcomes (1)

• SCORAD measurment

  SCORAD (Scoring Atopic Dermatitis) : from 0 up to 103

  Day 0; Day 7; Day 28; Day 70

Secondary Outcomes (3)

• DLQI (Quality of life)

  Day 7 and Day 14

• Itch NRS scale (Itch Numeric Rating Scale)

  Day 4 and Day 14

• Use of topical steroids

  Day 70 at the end of the study

Study Arms (2)

Bras Lipikar AP+M (La Roche Posay)

ACTIVE COMPARATOR

Other: Baume Relipid+

Bras baume RELIPID+ (Laboratoires Gilbert)

EXPERIMENTAL

Other: Baume Relipid+

Interventions

Baume Relipid+ OTHER

Application of daily emollient

Bras Lipikar AP+M (La Roche Posay); Bras baume RELIPID+ (Laboratoires Gilbert)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who decline participation
• Patients under legal guardianship, curatorship, legal protection, or judicial safeguard
• Patients with a SCORAD indicating the need for systemic therapy

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU Caen Normandie

Caen, Normandy, France

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: January 22, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)