EFFICACY AND TOLERANCE OF AN EYELID BALM IN COMBINATION WITH TACROLIMUS 0.1% IN PATIENTS WITH EYELID ATOPIC DERMATITIS

NCT07819071 | Completed

• 1 other identifier: RV5258A20240941
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the tolerance and efficacy of a new emollient cream specifically dedicated to the eyelid area when applied in association with tacrolimus 0.1% in subjects suffering from eyelid Atopic Dermatitis.

Conditions

Atopic Dermatitis (AD)

Keywords

Atopic Dermatitis; Eczema; Flare; Pruritus; Cosmetic; Topical therapy

Outcome Measures

Primary Outcomes (9)

• Change in Functional Sign : Pruritus

  Evolution of pruritus self-assessed by the subject using a Numerical Rating Scale (NRS, 0-10; 0 = no symptom, 10 = worst imaginable symptom) on the investigational emollient eyelid area compared to the topical calcineurin inhibitor-only eyelid area

  Change from Visit 1 (Day 1 - before application), to 15 minutes after first product application ( Day 1, Time+15 min), Day 2 (home), Visit 2 (Day 3), Day 4 (home), Visit 3 (Day 5), Day 6 (home), Day 7 (home), Visit 4 (Day 8), and Visit 5 (Day 15)

• Change in Functional Sign : Discomfort

  Evolution of discomfort self-assessed by the subject using a Numerical Rating Scale (NRS, 0-10; 0 = no symptom, 10 = worst imaginable symptom) on the investigational emollient eyelid area compared to the topical calcineurin inhibitor-only eyelid area

  Change from Visit 1 (Day 1 - before application), to 15 minutes after first product application ( Day 1, Time+15 min), Day 2 (home), Visit 2 (Day 3), Day 4 (home), Visit 3 (Day 5), Day 6 (home), Day 7 (home), Visit 4 (Day 8), and Visit 5 (Day 15)

• Change in Functional Sign : Burning Sensation

  Evolution of burning sensation self-assessed by the subject using a Numerical Rating Scale (NRS, 0-10; 0 = no symptom, 10 = worst imaginable symptom) on the investigational emollient eyelid area compared to the topical calcineurin inhibitor-only eyelid area

  Change from Visit 1 (Day 1 - before application), to 15 minutes after first product application ( Day 1, Time+15 min), Day 2 (home), Visit 2 (Day 3), Day 4 (home), Visit 3 (Day 5), Day 6 (home), Day 7 (home), Visit 4 (Day 8), and Visit 5 (Day 15)

• Change in Functional Sign : Pain

  Evolution of pain self-assessed by the subject using a Numerical Rating Scale (NRS, 0-10; 0 = no symptom, 10 = worst imaginable symptom) on the investigational emollient eyelid area compared to the topical calcineurin inhibitor-only eyelid area

  Change from Visit 1 (Day 1 - before application), to 15 minutes after first product application ( Day 1, Time+15 min), Day 2 (home), Visit 2 (Day 3), Day 4 (home), Visit 3 (Day 5), Day 6 (home), Day 7 (home), Visit 4 (Day 8), and Visit 5 (Day 15)

• Change in L-SCORAD Score

  Evolution of the Local SCORAD (L-SCORAD) score assessed by the Investigator on each eyelid at each visit

  Change from Visit 1 (Day 1 - baseline), Visit 2 (Day 3), Visit 3 (Day 5), Visit 4 (Day 8), and Visit 5 (Day 15)

• Investigator's Global Assessment (IGA) of Atopic Eyelid Dermatitis

  Evolution of atopic eyelid dermatitis assessed by the Investigator using a 6-point scale (0 = worse to 5 = total resolution) on each eyelid compared to baseline

  Visit 2 (Day 3), Visit 3 (Day 5), Visit 4 (Day 8) and Visit 5 (Day 15).

• Investigator's Global Assessment (IGA) of Atopic Eyelid Dermatitis

  Evolution of atopic eyelid dermatitis self-assessed by the subject using a 6-point scale (0 = worse to 5 = total resolution) on each eyelid compared to baseline

  Visit 2 (Day 3), Visit 3 (Day 5), Visit 4 (Day 8) and Visit 5 (Day 15).

• Local dermatological tolerance of the tested product

  Assessment of the dermatological tolerance of the tested eye contour emollient applied twice daily in combination with tacrolimus 0.1% on the tested eyelid area, compared to the topical calcineurin inhibitor-only eyelid area. Tolerance is assessed by the Investigator at each study visit. The results will take into account the clinical signs observed by the investigators and the signs reported by the subject based on a 5-point scale (From 1 = Excellent tolerance to 5 = Bad tolerance)

  Visit 1 (Day 1), Visit 2 (Day 3), Visit 3 (Day 5), Visit 4 (Day 8), and Visit 5 (Day 15)

• Acceptability Questionnaire assessment

  Acceptability questionnaire regarding the use and perceived efficacy of the tested product

  Visit 1 (Day 1, Time+15 min), Visit 2 (Day 3), Visit 3 (Day 5), Visit 4 (Day 8) and Visit 5 (Day 15).

Study Arms (2)

topical calcineurin inhibitor + tested eyelid balm

EXPERIMENTAL

Subjects receive the tested eyelid balm on one randomized eyelid for 2 weeks, in combination with twice-daily tacrolimus 0.1% initiated 24 hours prior to study inclusion.

Other: Tested Emollient RV5258A; Other: tacrolimus 0.1%

topical calcineurin inhibitor alone.

ACTIVE COMPARATOR

Subjects receive twice-daily applications of tacrolimus 0.1% (topical calcineurin inhibitor, TCI, initiated 24 hours prior to study inclusion) on the contralateral eyelid for 2 weeks

Other: tacrolimus 0.1%

Interventions

Tested Emollient RV5258A OTHER

Topical application of the investigational eye contour emollient on one randomized eyelid over a 2-week treatment period

topical calcineurin inhibitor + tested eyelid balm

tacrolimus 0.1% OTHER

Twice-daily topical application of tacrolimus 0.1% initiated 24 hours prior to study inclusion and continued over a 2-week treatment period. Tacrolimus 0.1% is considered an out-of-protocol concomitant treatment.

topical calcineurin inhibitor + tested eyelid balm; topical calcineurin inhibitor alone.

Eligibility Criteria

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

* Female and Male * Subjects from 18 to 65 years old * Subject who has signed his/her written informed consent for his/her participation in the study and a photograph authorization * Subject presenting atopic dermatitis according to the definition of "the U.K Working Party's Diagnostic Criteria for Atopic Dermatitis." * Subjects with Atopic Eyelid Dermatitis with bilateral involvement of similar surface and same intensity (no more than 1 point of difference in the total L-SCORAD) * Subjects with atopic dermatitis flare-up on the eyelids requiring topical calcineurin inhibitor treatment (tacrolimus 0.1%) and initiated within the last 24 hours * Subject who has started a topical calcineurin inhibitor treatment (tacrolimus 0.1%; twice a day) on the eyelids within the last 24 hours prior to the inclusion * Subject who used the same cleansing product on face the same make-up (if applicable) for at least two weeks before inclusion and remain stable during the whole study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Centrum Medyczne "Tu Się Leczy" Norwida

Gdansk, Poland, 80280, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus

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; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-individual, split-face, randomized comparative study conducted in adult subjects suffering from an eyelid atopic dermatitis (AD) and requiring topical calcineurin inhibitor (TCI) treatment. Enrolled subjects apply the tested eyelid balm in combination with topical calcineurin inhibitor twice daily on one randomized eyelid, compared to the contralateral eyelid treated with topical calcineurin inhibitor alone, over a 2-week treatment period.

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 14, 2026
• Study Start: November 3, 2025
• Primary Completion: January 10, 2026
• Study Completion: January 10, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

PL (1)