Atopic DermatitisNCT07014007
Tolerance and Efficacy Open-label Study With RV4421B, in Various Populations With Atopic Dermatitis for 12 Weeks
A study testing RV4421B- EV0407 in people with Atopic Dermatitis, run by Pierre Fabre Dermo Cosmetique at 1 site in Mauritius.
Trial summary
Pierre Fabre Laboratories have developed a cream with medical device status, RV4421B-EV0407 indicated for the treatment of eczemas, including atopic eczema, contact eczema and chronic hand eczema. This product is already marketed in several countries. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- RV4421B- EV0407
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteMauritius
- Study dates
- 30 Sep 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, with any phototype according to Fitzpatrick classification aged:
- Group 1 (infants group): from 3 months to 23 months old included
- Group 2 (children group): from 24 months to 12 years old included
- Group 3 (teenagers \& adults group): from 13 years old
- Subject with a diagnosis of atopic dermatitis according to the U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis (Williams HC, Burney PG, et al.).
- Subject with studied areas (lesions and prevailing xerotic areas) limited up to 30% of the body surface area
Show all 10Show fewer
- Subject with mild to moderate Atopic Dermatitis
- Criteria related to treatments and/or products:
- Topical corticosteroids treatments (following international treatment guidelines for each age sub-group and including investigator agreement) applied on AD lesions areas since 1 to 5 days before the inclusion and ongoing at the time of inclusion. *
- The investigator will be authorized to adjust the treatment during the study.
Who cannot join
- Criteria related to the skin condition or the disease:
- Infant with Atopic Dermatitis lesions or prevailing xerotic areas located on the diaper (groups 1 \& 2)
- Subject with history of allergy or intolerance to any of the study product(s) ingredients or material used for the research
- Subject having any other dermatologic condition than Atopic Dermatitis, or characteristics (like tattoo…) on the studied areas liable to interfere with the study assessments
- Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute or chronic)
Show all 24Show fewer
- Criteria related to treatments and/or products:
- Systemic biological immunosuppressive treatment established or modified within 12 weeks before the inclusion or planned to be started during the study
- Phototherapy performed within 4 weeks before the inclusion visit or planned to be started during the study
- Systemic non-biological immunosuppressive treatment established or modified within 4 weeks before the inclusion or ongoing or planned to be started during the study
- Systemic corticosteroids treatment established or modified within 4 weeks before the inclusion or ongoing or planned to be started during the study
- Systemic antibiotics for dermatological purposes treatment established or modified within 2 weeks before the inclusion or ongoing or planned to be started during the study
- Systemic antihistaminic treatment established or modified within 2 weeks before the inclusion
- Topical treatments (immunomodulators (TIMs), non-steroidal anti-inflammatory, antihistaminic, antibiotics for dermatological purposes or antiseptics) applied on studied areas within 1 week before the inclusion or ongoing or planned to be started during the study
- Any other topical treatment or product applied on studied areas incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study
- Skin care product (including moisturizer) applied on the whole body between the evening before the visit and the inclusion.
- Water and/or any cleansing product, applied on the whole body within 4 hours before the inclusion visit. If there is no studied area on the face, the subject is allowed to do a light face wash without time restriction (especially in the morning of the visit).
- Subject who plans to modify his/her usual moisturizer (allowed outside studied areas) and/or care habits during the study
- Treatment of the mother if the subject of group 1 and 2 is breastfed:
- Systemic biological immunosuppressive treatment established or modified within 12 weeks before the inclusion or planned to be started during the study
- Systemic non-biological immunosuppressive treatment established or modified within 4 weeks before the inclusion or planned to be started during the study
- Systemic corticosteroids established or modified within 2 weeks before the inclusion or planned to be started during the study
- Systemic antihistaminic established or modified within 2 weeks before the inclusion
- Systemic antibiotics for dermatological purposes established or modified within 1 week before the inclusion or planned to be started during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mauritius1 site, 1 recruiting
- Recruiting
Insight Research Ltd
Quatre Bornes, Mauritius, 742CU001
Ashlam DOARIKA, +2304670231, adoarika@gmail.com
Ashlam DOARIKA
About this study
Official title: Open-label Study to Assess the Tolerance and Efficacy of the Product RV4421B-EV0407, Applied in Paediatric and Adult Populations With Mild to Moderate Atopic Dermatitis for 12 Weeks
Pierre Fabre Laboratories have developed a cream with medical device status, RV4421B-EV0407 indicated for the treatment of eczemas, including atopic eczema, contact eczema and chronic hand eczema.
This product is already marketed in several countries. The objective of this clinical study is to evaluate the safety and efficacy of the study product when used alone or in association with topical corticosteroid therapy, in an ethnically diverse adult and pediatric population (including dark skin) and over a long period of time with a 12-week follow-up.
Read more
5 visits are planned:
- Visit 1: Inclusion visit (Day 1)
- Visit 2: Intermediate visit (Phone visit - Between Day 8 and Day 15)
- Visit 3: Intermediate visit (Day 29 ± 3 days)
- Visit 4: Intermediate visit (Day 57 ± 3 days)
- Visit 5: End of study visit (Day 85 ± 3 days)
- Conditions
- Atopic Dermatitis
- Being tested
- RV4421B- EV0407
- Keywords
- Atopic Dermatitis, Eczema, Flare, Inflammatory skin disease, Altered skin barrier, Dryness, Itching, Redness, Stinging, Burning sensation
- Medical subject headings
- Dermatitis, Atopic, Eczema, Dermatitis, Pruritus, Erythema, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV4421B- EV0407Device
Medical device. Product application on studied areas, 5 to 15 minutes after corticosteroids application, if applicable. The maximum duration of application of medical device is 87 days.
| Study group | Role | What they receive |
|---|---|---|
| Infant group | Experimental | Subjects aged from 3 months to 23 months old included
Medical device: RV4421B- EV0407 the test product will be applied twice daily alone or in association with topical corticosteroids. Receives: Device: RV4421B- EV0407 |
| Children group | Experimental | Subjects aged from 24 months to 12 years old included
Medical device: RV4421B- EV0407 the test product will be applied twice daily alone or in association with topical corticosteroids. Receives: Device: RV4421B- EV0407 |
| Teenagers & adults group | Experimental | Subjects aged from 13 years old
Medical device: RV4421B- EV0407 the test product will be applied twice daily alone or in association with topical corticosteroids. Receives: Device: RV4421B- EV0407 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tolerance of the product RV4421B-EV0407 on studied areas
The results of the local tolerance will take into account the clinical signs observed by the investigators and the signs reported by the subject and/or the subjects' parent(s) or guardian(s), based on a 5-point scale (From 1 = Excellent tolerance to 5 = Bad tolerance)
Measured: Day 85
Secondary outcomes (11)
Local tolerance of the product RV4421B-EV0407 on studied areas at several timepoints
using the same 5-point scale as the primary criterion and same rules.
Measured: Day 1, 10 to 30 minutes after the first application, Day 29 & Day 57
Recording of adverse events
At each visit, the occurrence of Adverse Events since the last visit will be determined by the subject's / parent(s) or guardian(s) spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation. All AEs will be reported on the CRF
Measured: From Day 1 to Day 85
Local-SCORAD (SCORing Atopic Dermatitis)
Local -SCORAD (SCORing Atopic Dermatitis) will be assessed by the investigator on target area (= area most representative of Atopic Dermatitis severity of the whole body) on a scale ranged from 0 to 15, at each visit (except the Visit 2).
Each of 5 objective signs of the SCORAD (Erythema, Oedema/papulation, Oozing/Crusts, Excoriation, and Lichenification) will be rated from 0 (absent) to 3 (severe) independently
Measured: Day 1, Day 29, Day 57 & Day 85
SCORAD (SCORing Atopic Dermatitis)
SCORAD will be assessed by the investigator at each visit (except the Visit 2). The SCORAD is a scoring system based on the assessment of extent and intensity in a standardized manner. The complete system is called SCORAD index and takes into account the extent of the lesions, the severity of the clinical signs (objective signs) and the subjective symptoms (pruritus, sleep loss) reported on a Visual Analogue Scale (VAS).
The extent of lesions is scored on an evaluation form. The intensity is determined by grading each of the six items on a scale from 0 to 3 (erythema, oedema/papulation, oozing/crusts, excoriation, lichenification and dryness). Each item should be scored on the most representative area for a given intensity item.
Measured: Day 1, Day 29, Day 57 & Day 85
IGA (Investigator's Global Assessment)
IGA (Investigator's Global Assessment) will be assessed by the investigator on a 6-point scale ranged from 0 (= clear) to 5 (=very severe disease), at each visit (except the Visit 2).
Measured: Day 1, Day 29, Day 57 & Day 85
PO-SCORAD (Patient Oriented SCORing Atopic Dermatitis)
PO-SCORAD (Patient Oriented SCORing Atopic Dermatitis) will be assessed by the subject / subject's parent(s) or guardian(s) every 2 weeks* from Day 1 to Day 85 (± 3 days) The PO-SCORAD index and each of its intensity items components will be assessed on a scale ranged from 0 to 3 (0=none; 1=mild; 2=moderate; 3=severe).
The PO-SCORAD is composed of 3 parts:
- Part 1: Extent: Surface area of skin affected by eczema (drawing/colouring the infected area on a scheme)
- Part 2 : Objective signs:
- Evaluation on a 4-point scale (from 0 (=none) to 3(=severe) of the dryness of the skin without eczema
- Evaluation on a 4-point scale (from 0 (=none) to 3(=severe) of the severity of the eczema: redness of the skin affected by eczema, swelling, oozing/crust, scratching and thickening
- Part 3 : Subjective symptoms (evaluation of the sleep disturbance and the itching)
Measured: Every 2 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 1 to Day 85
SGA (Subject's Global Assessment)
SGA (Subject's Global Assessment) will be assessed by the subject / subject's parent(s) or guardian(s) on a 5-point scale ranged from -2 (=Significant worsening) to +2 (=Significant improvement), every 2 weeks in comparison to Atopic Dermatitis intensity baseline: Day 1.
Measured: Every 2 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 15 to Day 85
Subject quality of life DLQI for subjects from 16 years
Subject quality of life will be assessed by the subject by means of the Dermatology Life Quality Index (DLQI) questionnaire every 4 weeks
This questionnaire of quality of life is designed to be completed with a one-week recall period. It is calculated by summing the score of 10 questions, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Every 4 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 29 to Day 85
Subject quality of life CDLQI for subjects from 4 years to 15 years included
Subject quality of life will be assessed by the subject by means of the Children's Dermatology Life Quality Index (CDLQI) questionnaire every 4 weeks
This questionnaire of quality of life is designed to be completed with a one-week recall period. It is calculated by summing the score of 10 questions, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Every 4 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 29 to Day 85
Subject quality of life IDQOL for subjects from 3 months to 3 years included
Subject quality of life will be assessed by the subject by means of the Infant Dermatology Quality of Life Index (IDQOL) questionnaire every 4 weeks
This questionnaire of quality of life is designed to be completed with a one-week recall period. It is calculated by summing the score of 10 questions, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Every 4 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 29 to Day 85
Subject's satisfaction questionnaire
Satisfaction as regards to the use of the test product will be assessed by the subject / subject's parent(s) or guardian(s) through a specific questionnaire.
Measured: at Day 1 (10 to 30 minutes after the 1st product application), within 2 days before Day 29 or at Day 29 (± 3 days), within 2 days before Day 85 or at Day 85 (± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start30 Sep 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
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
- NCT07014007
- Sponsor's protocol ID
- RV44221B20240736
- Status last verified
- May 2026
- First submitted
- 21 May 2025
- Last updated
- 5 May 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Assess the Tolerance and Efficacy of the Product RV4421B-EV0407, Applied in Paediatric and Adult Populations With Mild to Moderate Atopic Dermatitis for 12 Weeks
- ClinicalTrials.gov ID
- NCT07014007
- Acronym / sponsor ID
- RV44221B20240736
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Eczema, Flare, Inflammatory skin disease, Altered skin barrier, Dryness, Itching, Redness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Jun 2025 (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.
Pierre Fabre Laboratories have developed a cream with medical device status, RV4421B-EV0407 indicated for the treatment of eczemas, including atopic eczema, contact eczema and chronic hand eczema.
This product is already marketed in several countries. The objective of this clinical study is to evaluate the safety and efficacy of the study product when used alone or in association with topical corticosteroid therapy, in an ethnically diverse adult and pediatric population (including dark skin) and over a long period of time with a 12-week follow-up.
5 visits are planned:
- Visit 1: Inclusion visit (Day 1)
- Visit 2: Intermediate visit (Phone visit - Between Day 8 and Day 15)
- Visit 3: Intermediate visit (Day 29 ± 3 days)
- Visit 4: Intermediate visit (Day 57 ± 3 days)
- Visit 5: End of study visit (Day 85 ± 3 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infant group | Experimental | Device: RV4421B- EV0407Subjects aged from 3 months to 23 months old included Medical device: RV4421B- EV0407 the test product will be applied twice daily alone or in association with topical corticosteroids. |
| Children group | Experimental | Device: RV4421B- EV0407Subjects aged from 24 months to 12 years old included Medical device: RV4421B- EV0407 the test product will be applied twice daily alone or in association with topical corticosteroids. |
| Teenagers & adults group | Experimental | Device: RV4421B- EV0407Subjects aged from 13 years old Medical device: RV4421B- EV0407 the test product will be applied twice daily alone or in association with topical corticosteroids. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, with any phototype according to Fitzpatrick classification aged:
- Group 1 (infants group): from 3 months to 23 months old included
- Group 2 (children group): from 24 months to 12 years old included
- Group 3 (teenagers \& adults group): from 13 years old
- Subject with a diagnosis of atopic dermatitis according to the U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis (Williams HC, Burney PG, et al.).
Key exclusion criteria (24 listed)
- Infant with Atopic Dermatitis lesions or prevailing xerotic areas located on the diaper (groups 1 \& 2)
- Subject with history of allergy or intolerance to any of the study product(s) ingredients or material used for the research
- Subject having any other dermatologic condition than Atopic Dermatitis, or characteristics (like tattoo…) on the studied areas liable to interfere with the study assessments
- Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute or chronic)
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 |
|---|---|---|
| RV4421B- EV0407Medical device. Product application on studied areas, 5 to 15 minutes after corticosteroids application, if applicable. The maximum duration of application of medical device is 87 days. | Device | Children group, Infant group, Teenagers & adults group |
Primary outcome
Local tolerance of the product RV4421B-EV0407 on studied areas
Time frame: Day 85
The results of the local tolerance will take into account the clinical signs observed by the investigators and the signs reported by the subject and/or the subjects' parent(s) or guardian(s), based on a 5-point scale (From 1 = Excellent tolerance to 5 = Bad tolerance)
11 secondary outcomes
Local tolerance of the product RV4421B-EV0407 on studied areas at several timepoints
Time frame: Day 1, 10 to 30 minutes after the first application, Day 29 & Day 57
Recording of adverse events
Time frame: From Day 1 to Day 85
Local-SCORAD (SCORing Atopic Dermatitis)
Time frame: Day 1, Day 29, Day 57 & Day 85
SCORAD (SCORing Atopic Dermatitis)
Time frame: Day 1, Day 29, Day 57 & Day 85
IGA (Investigator's Global Assessment)
Time frame: Day 1, Day 29, Day 57 & Day 85
PO-SCORAD (Patient Oriented SCORing Atopic Dermatitis)
Time frame: Every 2 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 1 to Day 85
SGA (Subject's Global Assessment)
Time frame: Every 2 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 15 to Day 85
Subject quality of life DLQI for subjects from 16 years
Time frame: Every 4 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 29 to Day 85
Subject quality of life CDLQI for subjects from 4 years to 15 years included
Time frame: Every 4 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 29 to Day 85
Subject quality of life IDQOL for subjects from 3 months to 3 years included
Time frame: Every 4 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 29 to Day 85
Subject's satisfaction questionnaire
Time frame: at Day 1 (10 to 30 minutes after the 1st product application), within 2 days before Day 29 or at Day 29 (± 3 days), within 2 days before Day 85 or at Day 85 (± 3 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RV4421B- EV0407 in people with Atopic Dermatitis, run by Pierre Fabre Dermo Cosmetique at 1 site in Mauritius.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 5 May 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 Mauritius. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adeline Bacquey (+33534506533, adeline.bacquey@pierre-fabre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tolerance of the product RV4421B-EV0407 on studied areas (time frame: Day 85). 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 5 May 2026.