Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood
-
- STATUS
- Recruiting
-
- participants needed
- 360
-
- sponsor
- Infectopharm Arzneimittel GmbH
Summary
In this study, it will be investigated if symptoms of atopic dermatitis of children with high familial risk will be delayed beyond the 6th or even 12th month of life by applying the SanaCutan Basiscreme.
Description
Enrolled healthy newborns with high risk for atopic dermatitis will be 1:1 randomised into treatment and control group. The treatment group receives the SanaCutan Basiscreme for twice daily skin application until the age of 6 months (main phase; half of them until the age of 12 months (main + follow-up phase)), whereas the control group should avoid skin care products. Guardians of both groups are requested to document all applied skin care products in a diary. In regular visits at the study sites, a blinded physician investigates the skin of the children. In case of an atopic dermatitis (= atopic dermatitis has to be diagnosed in at least two visits with an interval of at least four weeks), the severity will be examined (SCORAD) and the treatment with SanaCutan Basiscreme will be terminated. All children will be followed up until the age of 6 months (end of main phase). This is the time when a blood test will be conducted to determine sensitization against food and inhalant allergens and total IgE. If children do not develop an atopic dermatitis in the main phase, the study continues until they receive the diagnosis (up to a maximum of 12 months, end of follow-up phase).
Details
| Condition | ATOPIC DERMATITIS, eczema (atopic dermatitis), ATOPIC DERMATITIS, dermatitis, atopic, Dermatitis, hand dermatitis, Neonate, dermatitis, atopic |
|---|---|
| Age | 1years or below |
| Treatment | SanaCutan Basiscreme |
| Clinical Study Identifier | NCT04398758 |
| Sponsor | Infectopharm Arzneimittel GmbH |
| Last Modified on | 19 February 2024 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy AnnotationsStudy Notes
Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.
Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!
No annotations made yet
Add a private note
- Select a piece of text from the left.
- Add notes visible only to you.
- Send it to people through a passcode protected link.
Study Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.