Atopic Dermatitis (AD)
Conditions
Keywords
Atopic Dermatitis, Eczema, Flare, Pruritus, Cosmetic, Topical therapy
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.
Detailed description
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.
Interventions
OTHERTested Emollient RV5258A
Topical application of the investigational eye contour emollient on one randomized eyelid over a 2-week treatment period
OTHERtacrolimus 0.1%
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.
Sponsors
Pierre Fabre Dermo Cosmetique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Sign : Pruritus | 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 |
| Change in Functional Sign : Discomfort | 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 |
| Change in Functional Sign : Burning Sensation | 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 |
| Change in Functional Sign : Pain | 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 |
| Change in L-SCORAD Score | 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 |
| Investigator's Global Assessment (IGA) of Atopic Eyelid Dermatitis | 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 |
| Local dermatological tolerance of the tested product | 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) |
| Acceptability Questionnaire assessment | 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 |
Countries
Poland
Outcome results
None listed