An interventional study of Tested Emollient RV5258A and tacrolimus 0.1% in Atopic Dermatitis (AD), sponsored by Pierre Fabre Dermo Cosmetique. Completed at 1 site in Poland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Pierre Fabre Dermo Cosmetique (part of Pierre Fabre) · Not applicable, Interventional, and Supportive care
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 33 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Pierre Fabre Dermo Cosmetique is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%
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%
Topical application of the investigational eye contour emollient on one randomized eyelid over a 2-week treatment period
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.
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)
Change in L-SCORAD Score
Evolution of the Local SCORAD (L-SCORAD) score assessed by the Investigator on each eyelid at each visit
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)
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
Time frame: 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
Time frame: 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)
Time frame: 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
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).
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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