New eczema cream studied in kids and adults – could reduce steroid use?
NCT ID NCT07014007
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a cream called RV4421B-EV0407, a medical device already sold in some countries, for mild to moderate atopic dermatitis (eczema). It includes 105 participants from 3 months old to adults, with diverse skin types. The cream is used alone or with steroid creams for up to 12 weeks. Researchers are checking how well the skin tolerates it and if it helps control eczema.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RV4421B-EV0407 cream (medical device)
- What this could lead to
- If successful, this could provide a well-tolerated, steroid-sparing option for managing eczema symptoms across diverse skin types and ages.
- What could go wrong
- This is an early-phase, open-label study with no placebo group, so results may be biased. The cream is already marketed, but long-term efficacy and safety in diverse populations are still being confirmed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 105 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 months and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * 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 * 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. Exclusion criteria: 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) 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Insight Research Ltd
RECRUITINGQuatre Bornes, Mauritius, 742CU001, Mauritius
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Other studies related to the condition(s) this trial covers.
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- Is your nose fueling infected eczema and scabies sores?
- Can an eczema drug reshape the Skin's microbial community?