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Completed

NCT Number: NCT07819071

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

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.

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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centrum Medyczne "Tu Się Leczy" Norwida

Gdansk, Poland, 80280

About this study

This study is conducted as a single-center, intra-individual, split-face, randomized study to evaluate the tolerance and efficacy of the tested e applied in combination with a topical calcineurin inhibitor (TCI) - tacrolimus 0.1% - in adult subjects suffering from an eyelid atopic dermatitis (AD). Eyelids are randomized to receive either twice-daily topical calcineurin inhibitor alone or a combination of twice-daily topical calcineurin inhibitor and the tested emollient. A total of 33 adult subjects are enrolled. Assessments are performed at Day 1, Day 3, Day 5, Day 8, and Day 15.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Tested Emollient RV5258A

Other

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

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.

Primary outcomes

  1. Change in Functional Sign : Pruritus

    Time frame: 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)

    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

  2. Change in Functional Sign : Discomfort

    Time frame: 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)

    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

  3. Change in Functional Sign : Burning Sensation

    Time frame: 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)

    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

  4. Change in Functional Sign : Pain

    Time frame: 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)

    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

  5. Change in L-SCORAD Score

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

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

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

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

    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

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

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

    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

  8. Local dermatological tolerance of the tested product

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

    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)

  9. Acceptability Questionnaire assessment

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

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

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

A RANDOMIZED COMPARATIVE SPLIT FACE STUDY TO EVALUATE THE EFFICACY AND TOLERANCE OF AN EYELID BALM IN COMBINATION WITH A TOPICAL CALCINEURIN INHIBITOR TREATMENT - TACROLIMUS 0.1 % - IN SUBJECTS WITH ATOPIC EYELID DERMATITIS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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