Evaluation of Paraffin White Soft Cream for Prophylaxis of Atopic Dermatitis in High-Risk Pediatric Populations: A Randomized, Investigator-Blinded Study

The primary objective of this study is to evaluate the **clinical efficacy** of SanaCutan Basiscreme in reducing the cumulative incidence of **atopic dermatitis** (AD) in infants with a high familial risk. This is assessed by comparing the treatment group using the cream with a control group receiving no treatment at the age of 6 months. Clinical efficacy is determined if the cumulative incidence of AD in the treatment group is significantly lower than in the control group, with a p-value of less than 0.05. AD is confirmed through at least two examinations, spaced at least four weeks apart, diagnosing AD and evidence of chronification.

Secondary objectives include: - Cumulative incidence of children with AD at various time points up to 12 months. - Cumulative incidence of children with a preliminary diagnosis of AD, regardless of chronification, at specified ages. - Time to onset of AD within the first year of life. - Cumulative incidence and frequency of children with **xerosis** and signs of itching at 6 and 12 months. - Cumulative incidence and frequency of children with other types of eczema at 6 and 12 months. - Severity of AD at detection up to 12 months. - Frequency of sensitization to food and inhalation allergens and total IgE levels at 6, 9, and 12 months. - Adverse events, including overall frequency, type, severity, and causality, with a focus on local reactions. - Drop-out rates and reasons up to 12 months. - Compliance with the use of the investigational product and other skin care products in both groups up to 12 months.

The clinical trial involves a study population of **infants** with a high familial risk of developing **atopic dermatitis**. The participants include both male and female newborns who are less than 3 weeks old, specifically up to the 21st day of life. The trial targets a vulnerable population, as it involves healthy newborns with at least one first-degree relative, such as a parent or sibling, who has a medically diagnosed history of atopic dermatitis. The selection of participants requires a written declaration of consent from all legal guardians. The sponsor has not provided information regarding the total number of participants in the study. The trial does not specify any particular lifestyle considerations such as diet or physical activity for the participants, given the age and health status of the study population.

The clinical trial is a **prospective**, randomized, non-treatment controlled, investigator-blinded, multicenter study designed to evaluate the prophylactic efficacy of a moisturizing barrier-stabilizing skin cream in preventing early childhood symptoms of **atopic dermatitis** in high-risk children. The trial aims to compare the cumulative incidence of atopic dermatitis in infants with a high familial risk between a treatment group using the cream and a control group without treatment. The primary endpoint is the cumulative incidence of atopic dermatitis at six months of age, confirmed through at least two examinations at an interval of four weeks. Secondary endpoints include the cumulative incidence of atopic dermatitis at various time points, the time to onset of the condition, and the frequency of related symptoms such as xerosis and itching.

The trial is expected to run from January 2020 to December 2026, with participant involvement lasting up to 12 months. The study begins with an inclusion visit, where healthy newborns under three weeks of age with a high familial risk of atopic dermatitis are screened for eligibility. Key inclusion criteria include having at least one first-degree relative with a history of medically diagnosed atopic dermatitis and obtaining written consent from all legal guardians. There are no specified exclusion criteria. Participants will undergo regular follow-up visits to monitor the development of atopic dermatitis and other related symptoms, with assessments at 12 and 16 weeks, and at 6, 9, and 12 months of age. The end-of-study visit will occur at 12 months, marking the conclusion of the participant's involvement in the trial.

Participants may be withdrawn from the study if they experience adverse events that necessitate discontinuation, or if they fail to comply with the study protocol. The trial is conducted under a Phase III clinical trial framework, ensuring rigorous evaluation of the cream's efficacy and safety. The investigational product, SanaCutan® Basiscreme, is applied topically, with a maximum daily dose of 12 grams and a total dose limit of 4500 grams over the treatment period. The study's findings will contribute to understanding the potential of topical emollients in preventing atopic dermatitis in high-risk pediatric populations.

The clinical trial involves the use of **SanaCutan® Basiscreme**, a topical cream formulated with **paraffin white soft** as the active substance. This product is classified under the ATC code D02A, which denotes emollients and protectives. The cream is manufactured by PÄDIA GMBH and is not a pediatric formulation. The pharmaceutical form of the product is a cream, and it is applied topically. The maximum daily dose is 12 grams, with a total maximum dose of 4500 grams over the treatment period. The maximum treatment period is 13 weeks. The cream is intended to be used continuously as a moisturizing barrier-stabilizing agent to prevent early childhood symptoms of atopic dermatitis in high-risk children.

In this study, the experimental treatment group will receive the SanaCutan® Basiscreme, while the control group will not receive any treatment. The study is designed to compare the cumulative incidence of atopic dermatitis between the treatment group and the control group at the age of 6 months. The primary objective is to determine if the incidence of atopic dermatitis in the treatment group is significantly lower than in the control group, with a significance level of p < 0.05. The study is prospective, randomized, non-treatment controlled, investigator-blinded, and multicenter in nature.

The clinical trial aims to assess the efficacy of SanaCutan® Basiscreme in preventing early childhood symptoms of **atopic dermatitis** (AD) in high-risk infants. The primary endpoint for evaluating efficacy is the cumulative incidence of AD at the age of 6 months. A confirmed diagnosis of AD requires at least two examinations, spaced at least four weeks apart, demonstrating initial diagnosis and evidence of chronification. The primary objective is achieved if the treatment group shows a significantly lower cumulative incidence of AD compared to the control group (p < 0.05).

Secondary endpoints include the cumulative incidence of AD at various time points (12 and 16 weeks, 9, 12, and 6-12 months), time to onset of AD, and the incidence and frequency of related symptoms such as xerosis, itching, and eczema of other types at 6 and 12 months. Additional assessments involve the severity of AD, frequency of sensitization to allergens, and total IgE levels at 6, 9, and 12 months. Adverse events, compliance with the investigational product, and use of other skin care products are also monitored up to 12 months of age.