An interventional study of RV4421B- EV0407 in Atopic Dermatitis, sponsored by Pierre Fabre Dermo Cosmetique. Recruiting at 1 site in Mauritius. Open to participants aged 3 Months and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Pierre Fabre Dermo Cosmetique (part of Pierre Fabre) · Not applicable, Interventional, and Treatment
Among 13 studies in Dermatitis, Atopic by Pierre Fabre Dermo Cosmetique — 1 open to participants now, 1 under way, none of them phase 3. Dermatitis, Atopic · Pierre Fabre Dermo Cosmetique.
Among the 13 studies in Dermatitis, Atopic by Pierre Fabre Dermo Cosmetique, this one is one of 7 that started in 2025, is one of 7 with no phase, and was the 8th registered.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 105 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →1 of the 13 studies in Dermatitis, Atopic by Pierre Fabre Dermo Cosmetique is open now, in 1 country. Each count lists the studies.
Of the 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.
This study: 3 Months and older · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 7 started in 2025.
Median enrollment 50 across the 7 interventional studies, 37 across the 6 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.
Pierre Fabre Dermo Cosmetique is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
1 of the studies in Dermatitis, Atopic by Pierre Fabre Dermo Cosmetique that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07014007Pierre Fabre Dermo CosmetiqueTolerance and Efficacy Open-label Study With RV4421B, in Various Populations With Atopic Dermatitis for 12 Weeks | 2026-11 |
Among the 13 studies in Dermatitis, Atopic by Pierre Fabre Dermo Cosmetique, from their registry updates:
Nothing recorded among them since 2026-09-25.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Criteria related to treatments and/or products:
*The investigator will be authorized to adjust the treatment during the study.
Exclusion criteria:
Criteria related to the skin condition or the disease:
Criteria related to treatments and/or products:
Treatment of the mother if the subject of group 1 and 2 is breastfed:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: RV4421B- EV0407
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.
Device: RV4421B- EV0407
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.
Device: RV4421B- EV0407
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.
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)
Time frame: Day 85
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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)
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)
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.
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
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.
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
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.
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
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.
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
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.
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)
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Pierre Fabre Dermo Cosmetique →