Atopic Dermatitis (AD)NCT07819071
EFFICACY AND TOLERANCE OF AN EYELID BALM IN COMBINATION WITH TACROLIMUS 0.1% IN PATIENTS WITH EYELID ATOPIC DERMATITIS
A study testing Tested Emollient RV5258A and tacrolimus 0.1% in people with Atopic Dermatitis (AD), run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- Tested Emollient RV5258A and tacrolimus 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePoland
- Study dates
- 3 Nov 2025to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- Tested Emollient RV5258A, tacrolimus 0.1%
- Keywords
- Atopic Dermatitis, Eczema, Flare, Pruritus, Cosmetic, Topical therapy
- Medical subject headings
- Dermatitis, Atopic, Eczema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: tacrolimus 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Visit 1 (Day 1, Time+15 min), Visit 2 (Day 3), Visit 3 (Day 5), Visit 4 (Day 8) and Visit 5 (Day 15).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start3 Nov 2025
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819071
- Sponsor's protocol ID
- RV5258A20240941
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07819071
- Acronym / sponsor ID
- RV5258A20240941
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Atopic Dermatitis, Eczema, Flare, Pruritus, Cosmetic, Topical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| topical calcineurin inhibitor + tested eyelid balm | Experimental | Other: Tested Emollient RV5258A, Other: tacrolimus 0.1%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. |
| topical calcineurin inhibitor alone. | Active comparator | 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tested Emollient RV5258ATopical application of the investigational eye contour emollient on one randomized eyelid over a 2-week treatment period | Other | topical calcineurin inhibitor + tested eyelid balm |
| tacrolimus 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. | Other | topical calcineurin inhibitor + tested eyelid balm, topical calcineurin inhibitor alone. |
Primary outcome
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
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
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
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
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
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
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
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Related trials for Atopic Dermatitis (AD)
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 1
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
RecruitingPhase 2
PRA-216 Atopic Dermatitis Safety and Efficacy Study
Atopic Dermatitis (AD)
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tested Emollient RV5258A and tacrolimus 0.1% in people with Atopic Dermatitis (AD), run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.