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Tests treatment safety and results for Atopic Dermatitis
Official title Tolerance and Efficacy Open-label Study With RV4421B, in Various Populations With Atopic Dermatitis for 12 Weeks
ClinicalTrials.gov ID: NCT07014007
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or...
- Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute or chronic) Criteria related to treatments and/or products:
See the full eligibility criteria
Who can 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
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Quatre Bornes, Mauritius, Mauritius
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Quatre Bornes, Mauritius, Mauritius. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.