Study on the prevention of atopic dermatitis symptoms in children with a high risk of the disease through the regular use of a moisturizing skin cream

Overview

Sponsor-declared trial summary

Key facts

Sponsor

INFECTOPHARM Arzneimittel und Consilium GmbH

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

13 Jan 2020 → ongoing

Decision date (initial)

2024-10-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-513289-21-00

EudraCT number

2018-004762-33

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Safety, Efficacy

The MOPAD study aims to evaluate the clinical efficacy of the SanaCutan Basiscreme by comparing the cumulative incidence of atopic dermatitis (AD) in infants with high familial risk between the treatment group and the control group (without treatment) at the age of 6 months. A clinical efficacy (primary objective) is achieved if the cumulative AD incidence in the treatment group at the age of 6 months is significantly lower than in the control group (p < 0.05). AD is confirmed if in at least 2 examinations at an interval of at least 4 weeks (initial diagnosis + evidence of chronification) an AD is diagnosed. A confirmed AD is abbreviated as “AD” in the context of the study (this does not refer to the initial detection of AD symptoms).

Secondary objectives 12

1. Cumulative incidence of children with AD at 12 and 16 weeks, 9, 12 and 6-12 months
2. Cumulative incidence of children with preliminary diagnosis of atopic dermatitis (regardless of whether chronification is confirmed at 12 and 16 weeks, 6, 9 and 12 months of age
3. Time to onset of AD at 0-6, 6-12 and 0-12 months of age
4. Cumulative incidence and frequency of children with xerosis at 6 and 12 months of age
5. Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age
6. Cumulative incidence and frequency of children with eczema of other types at 6 and 12 months of age
7. Severity of AD at the time of detection of (confirmed) AD up to 12 and 16 weeks and 6, 9 and 12 months of age
8. Frequency of sensitization to food allergens (according to Fx5 test + hazelnut) and to inhalation allergens (according to Sx1 test) and total IgE at the age of 6, 9 and 12 months
9. Adverse events: overall frequency, type, severity, causality, with frequencies, separate presentation of local reactions up to 6 and 12 months of age
10. Drop-outs (with reasons) up to 6 and 12 months of age
11. Compliance regarding the use of the investigational medicinal product in the treatment group up to the age of 6, 12 and 6-12 months
12. Compliance regarding the use of other skin care products (not investigational medicinal product) in both groups up to the age of 6, 12 and 6-12 months

Conditions and MedDRA coding

Children with a high risk of developing atopic dermatitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Healthy newborns (male or female)
2. Age < 3 weeks (≤ 21st day of life)
3. High familial risk of atopic dermatitis with at least one 1st degree relative (parent or sibling) with a history of medically diagnosed atopic dermatitis
4. Written declaration of consent from all legal guardians

Exclusion criteria 16

1. Acute or chronic diseases
2. Acute fever (> 38.5 °C)
3. Serious congenital malformations
4. Hydrops fetalis
5. Immunodeficiency (of any kind)
6. Serious genetic skin diseases or skin conditions that make the use of skin creams unsuitable
7. Corticosteroid or calcineurin inhibitor use or taking cyclosporine
8. Prematurity (< 37 weeks)
9. Known hypersensitivity to any of the ingredients of SanaCutan Basiscreme
10. Limited legal capacity of the guardians
11. Inability of the guardians to understand the study instructions
12. Obvious unreliability or lack of cooperation of the guardians
13. Known alcohol, medication or drug addiction of the guardians
14. Dependence of the child or guardian on the sponsor or investigator
15. Previous participation in another clinical trial (since birth)
16. Previous participation in this study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary end point is defined as the cumulative incidence of atopic dermatitis (AD) at the age of 6 months. AD is confirmed if in at least 2 examinations at an interval of at least 4 weeks (initial diagnosis + evidence of chronification) an AD is diagnosed. A confirmed AD is abbreviated as "AD" in the context of the study (this does not refer to the initial detection of AD symptoms).

Secondary endpoints 12

1. Cumulative incidence of children with AD at 12 and 16 weeks, 9, 12 and 6-12 months
2. Cumulative incidence of children with preliminary diagnosis of atopic dermatitis (regardless of whether chronification is confirmed at 12 and 16 weeks, 6, 9 and 12 months of age
3. Time to onset of AD at 0-6, 6-12 and 0-12 months of age
4. Cumulative incidence and frequency of children with xerosis at 6 and 12 months of age
5. Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age
6. Cumulative incidence and frequency of children with eczema of other types at 6 and 12 months of age
7. Severity of AD at the time of detection of (confirmed) AD up to 12 and 16 weeks and 6, 9 and 12 months of age
8. Frequency of sensitization to food allergens (according to Fx5 test + hazelnut) and to inhalation allergens (according to Sx1 test) and total IgE at the age of 6, 9 and 12 months
9. Adverse events: overall frequency, type, severity, causality, with frequencies, separate presentation of local reactions up to 6 and 12 months of age
10. Drop-outs (with reasons) up to 6 and 12 months of age
11. Compliance regarding the use of the investigational medicinal product in the treatment group up to the age of 6, 12 and 6-12 months
12. Compliance regarding the use of other skin care products (not investigational medicinal product) in both groups up to the age of 6, 12 and 6-12 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

INFECTOPHARM Arzneimittel und Consilium GmbH

Sponsor organisation

INFECTOPHARM Arzneimittel und Consilium GmbH

Address

Von-Humboldt-Strasse 1

City

Heppenheim (Bergstrasse)

Postcode

64646

Country

Germany

Scientific contact point

Organisation

INFECTOPHARM Arzneimittel und Consilium GmbH

Contact name

InfectoPharm

Public contact point

Organisation

INFECTOPHARM Arzneimittel und Consilium GmbH

Contact name

InfectoPharm

Third parties 1

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications