NCT07819071 - EFFICACY AND TOLERANCE OF AN EYELID BALM IN COMBINATION WITH TACROLIMUS 0.1% IN PATIENTS WITH EYELID ATOPIC DERMATITIS | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

33

Conditions

Atopic Dermatitis (AD)

Interventions

Tested Emollient RV5258AOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

* 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.

Locations (1)

Centrum Medyczne "Tu Się Leczy" Norwida

Gdansk, Poland, Poland

Outcomes

Primary Outcomes

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

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)

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

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)

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

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)

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

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)