Study on Preventing Atopic Dermatitis in High-Risk Children Using Paraffin White Soft Cream

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What is this study about?

This clinical trial is focused on studying the prevention of symptoms of atopic dermatitis in children who are at high risk of developing this condition. Atopic dermatitis, often referred to as eczema, is a skin condition that causes the skin to become itchy, red, and inflamed. The study will use a moisturizing skin cream called SanaCutan® Basiscreme, which contains the active ingredient paraffin white soft. This cream is designed to help stabilize the skin’s barrier and keep it moisturized.

The purpose of the study is to see if regular use of SanaCutan® Basiscreme can reduce the occurrence of atopic dermatitis in infants who have a high familial risk of the disease. The study will compare two groups of infants: one group will use the cream regularly, while the other group will not receive any treatment. The main goal is to determine if the group using the cream has a lower rate of developing atopic dermatitis by the age of 6 months compared to the group that does not use the cream.

Participants in the study will be monitored over a period of time to observe the development of atopic dermatitis and other related symptoms such as dry skin, itching, and eczema. The study will also track any adverse events or reactions to the cream. The findings will help understand the effectiveness of the cream in preventing atopic dermatitis in high-risk children.

1 joining the study

Upon joining the study, the child must be a healthy newborn, less than 3 weeks old, with a high familial risk of developing atopic dermatitis. This means at least one parent or sibling has a history of medically diagnosed atopic dermatitis.

A written declaration of consent from all legal guardians is required to participate in the study.

2 treatment group assignment

The child will be randomly assigned to either the treatment group or the control group. The treatment group will use the SanaCutan® Basiscreme, a moisturizing skin cream, while the control group will not receive any treatment.

3 application of cream

If assigned to the treatment group, the SanaCutan® Basiscreme should be applied topically. This means the cream is applied directly to the skin.

The cream should be used regularly as instructed by the study team to help prevent symptoms of atopic dermatitis.

4 regular check-ups

Regular check-ups will be conducted to monitor the child’s skin condition and overall health. These check-ups will help determine if atopic dermatitis develops and assess the effectiveness of the cream.

The primary goal is to evaluate the incidence of atopic dermatitis at 6 months of age. Additional assessments will occur at 12 and 16 weeks, and at 9, 12, and 6-12 months.

5 monitoring for symptoms

The study will monitor for symptoms such as dry skin (xerosis), itching, and other types of eczema at 6 and 12 months.

The severity of atopic dermatitis, if confirmed, will be assessed at various intervals up to 12 months.

6 allergy testing

The study will include tests for sensitization to food and inhalation allergens at 6, 9, and 12 months. This involves checking for reactions to common allergens.

7 reporting adverse events

Any adverse events, such as unexpected reactions or side effects, will be recorded. This includes the type, severity, and possible causes of these events.

Local reactions to the cream, if any, will be specifically noted up to 6 and 12 months.

8 compliance monitoring

The study will track how well participants follow the instructions for using the cream in the treatment group.

The use of other skin care products will also be monitored in both groups to ensure accurate study results.

Who Can Join the Study?

Healthy newborns, which means babies who are born without any health problems.
Age less than 3 weeks old (up to the 21st day of life).
High familial risk of atopic dermatitis, which means at least one close family member (like a parent or sibling) has been medically diagnosed with atopic dermatitis.
Written consent from all legal guardians, meaning that the people responsible for the baby agree in writing for the baby to participate in the study.

Who Cannot Join the Study?

Children who do not have a high risk of developing atopic dermatitis (a skin condition that causes itchy and inflamed skin).
Children who are not in the age range specified for the study.
Children who have not been confirmed to have a high familial risk of atopic dermatitis.
Children who have not been diagnosed with atopic dermatitis in at least two examinations, with at least four weeks between each examination.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Gemeinschaftspraxis für Kinder- und Jugendmedizin	Tuttlingen	Germany
Kinderaerztliche Gemeinschaftspraxis Wolfsburg	Wolfsburg	Germany

Other Sites

Site Name	City	Country
Evangelisches Krankenhaus Duesseldorf	Duesseldorf	Germany
Marien-Hospital Wesel gGmbH	Wesel	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Evangelisches Klinikum Bethel gGmbH	Bielefeld	Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH	Regensburg	Germany
Ulxchjfvuwuelqvzdbacp Akuebeoh	Augsburg	Germany
Krfcef fhy Khuaocx ucv Jtebzfasglqws dgf Roxvfikpajrltlwm Bmvixg ia Scr Jafxcatyftulat	Bochum	Germany
Pyjfpwlq Woicvwlbf	Wolfsburg	Germany
Prboza fha Kejzjdo ukw Jmcgsibgjkecq	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.01.2020

Trial locations

Investigated drugs:

Paraffin White Soft

SanaCutan Basiscreme is a moisturizing cream used in this clinical trial to help prevent early symptoms of atopic dermatitis in young children who are at high risk of developing this skin condition. The cream works by stabilizing the skin’s natural barrier, which can help protect against irritants and allergens that might trigger atopic dermatitis. In the study, the cream is applied continuously to see if it can reduce the number of children who develop atopic dermatitis by the age of 6 months compared to those who do not receive any treatment. The goal is to see if using this cream can significantly lower the chances of developing this skin condition in infants.

Investigated diseases:

Dermatitis atopic

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood and can persist into adulthood. The disease progresses through periods of flare-ups and remissions, where symptoms can worsen and then improve. The skin’s barrier function is compromised, leading to increased sensitivity and susceptibility to irritants and allergens. Over time, repeated scratching can cause the skin to thicken and become leathery. The condition is often associated with other atopic diseases such as asthma and allergic rhinitis.

Trial ID:

2024-513289-21-00

Protocol code:

MOPAD

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Atopic Dermatitis in High-Risk Children Using Paraffin White Soft Cream

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