Clinical trial • Phase III • Dermatology

PARAFFIN WHITE SOFT for Atopic dermatitis

Phase III trial of PARAFFIN WHITE SOFT for Atopic dermatitis. Randomised, control group without treatment (no specified active comparator)..

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Atopic dermatitis
Trial Stage
Phase III
Drug Modality
Other
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
17-09-2024
First CTIS Authorization Date
17-10-2024

Trial design

Randomised, control group without treatment (no specified active comparator). Phase III trial across 11 sites in Germany.

Randomised
Yes
Comparator
Control group without treatment (no specified active comparator).
Target Sample Size
360

Eligibility

Recruits 360 paediatric patients.

Vulnerable Population
The trial enrolls newborns/infants (vulnerable population). Written declaration of consent from all legal guardians is required. The protocol excludes guardians with limited legal capacity, inability to understand study instructions, obvious unreliability or lack of cooperation, known substance addiction, or dependence of the child/guardian on the sponsor or investigator. No assent process for participants is described in the provided record.

Inclusion criteria

  • {"criterion_text":"- Healthy newborns (male or female)\n- Age < 3 weeks (≤ 21st day of life)\n- High familial risk of atopic dermatitis with at least one 1st degree relative (parent or sibling) with a history of medically diagnosed atopic dermatitis\n- Written declaration of consent from all legal guardians"}

Exclusion criteria

  • {"criterion_text":"- Acute or chronic diseases\n- Limited legal capacity of the guardians\n- Inability of the guardians to understand the study instructions\n- Obvious unreliability or lack of cooperation of the guardians\n- Known alcohol, medication or drug addiction of the guardians\n- Dependence of the child or guardian on the sponsor or investigator\n- Previous participation in another clinical trial (since birth)\n- Previous participation in this study\n- Acute fever (> 38.5 °C)\n- Serious congenital malformations\n- Hydrops fetalis\n- Immunodeficiency (of any kind)\n- Serious genetic skin diseases or skin conditions that make the use of skin creams unsuitable\n- Corticosteroid or calcineurin inhibitor use or taking cyclosporine\n- Prematurity (< 37 weeks)\n- Known hypersensitivity to any of the ingredients of SanaCutan Basiscreme"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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).","definition_or_measurement_approach":"Cumulative incidence of AD at age 6 months; AD confirmation requires diagnosis in at least 2 examinations ≥4 weeks apart (initial diagnosis plus evidence of chronification)."}

Secondary endpoints

  • {"endpoint_text":"- Cumulative incidence of children with AD at 12 and 16 weeks, 9, 12 and 6-12 months\n- 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\n- Time to onset of AD at 0-6, 6-12 and 0-12 months of age\n- Cumulative incidence and frequency of children with xerosis at 6 and 12 months of age\n- Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age\n- Cumulative incidence and frequency of children with eczema of other types at 6 and 12 months of age\n- 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\n- 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\n- Adverse events: overall frequency, type, severity, causality, with frequencies, separate presentation of local reactions up to 6 and 12 months of age\n- Drop-outs (with reasons) up to 6 and 12 months of age\n- Compliance regarding the use of the investigational medicinal product in the treatment group up to the age of 6, 12 and 6-12 months\n- 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","definition_or_measurement_approach":"Endpoints are assessed at the specified ages/time windows (weeks/months) as listed for each endpoint; many are cumulative incidence measures at defined visit ages or time-to-event (time to onset). Sensitization measured by specified tests (Fx5 + hazelnut for food; Sx1 for inhalation) and total IgE at 6, 9, 12 months. Adverse events recorded by frequency, type, severity, causality; local reactions reported separately up to 6 and 12 months."}

Recruitment

Planned Sample Size
360
Recruitment Window Months
84
Consent Approach
Written informed consent required from all legal guardians. A subject information and informed consent form document is listed for publication. No participant assent process is described in the provided record; consent is guardian-signed.

Geography

Total Number Of Sites
11
Total Number Of Participants
360

Germany

Earliest CTIS Part Ii Submission Date
01-10-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
533
Number Of Sites
11
Number Of Participants
360

Sites

Site Name
Evangelisches Krankenhaus Duesseldorf
Department Name
Klinik für Kinder- und Jugendliche
Principal Investigator Name
Monika Gappa
Principal Investigator Email
monika.gappa@evk-duesseldorf.de
Contact Person Name
Monika Gappa
Site Name
Praxis für Kinder- und Jugendmedizin
Department Name
-
Principal Investigator Name
Siri Roßberg
Principal Investigator Email
praxis@praxis-muskauer.de
Contact Person Name
Siri Roßberg
Contact Person Email
praxis@praxis-muskauer.de
Site Name
Gemeinschaftspraxis für Kinder- und Jugendmedizin
Department Name
-
Principal Investigator Name
Ralph Maier
Principal Investigator Email
praxis@kinderaerzte-tuttlingen.de
Contact Person Name
Ralph Maier
Site Name
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital
Department Name
Kinderklinik
Principal Investigator Name
Anne Schlegtendal
Principal Investigator Email
anne.schlegtendal@klinikum-bochum.de
Contact Person Name
Anne Schlegtendal
Site Name
Universitaetsklinikum Augsburg
Department Name
II. Klinik für Kinder und Jugendliche
Principal Investigator Name
Michael Gerstlauer
Principal Investigator Email
Michael.Gerstlauer@uk-augsburg.de
Contact Person Name
Michael Gerstlauer
Site Name
Marien-Hospital Wesel gGmbH
Department Name
Klinik für Kinder und Jugendliche
Principal Investigator Name
Willem Geurts van Kessel
Principal Investigator Email
Willem.GeurtsvanKessel@prohomine.de
Contact Person Name
Willem Geurts van Kessel
Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Klinik für Kinder- und Jugendmedizin
Principal Investigator Name
Eckard Hamelmann
Principal Investigator Email
eckard.hamelmann@evkb.de
Contact Person Name
Eckard Hamelmann
Contact Person Email
eckard.hamelmann@evkb.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Pädiatrie m. S. Pneumologie und Immunologie mit Intensivmedizin
Principal Investigator Name
Kirsten Beyer
Principal Investigator Email
kirsten.beyer@charite.de
Contact Person Name
Kirsten Beyer
Contact Person Email
kirsten.beyer@charite.de
Site Name
PediaMed Wolfsburg
Department Name
-
Principal Investigator Name
Maria Pniok
Principal Investigator Email
kinderaerztinnen@web.de
Contact Person Name
Maria Pniok
Contact Person Email
kinderaerztinnen@web.de
Site Name
Kinderaerztliche Gemeinschaftspraxis Wolfsburg
Department Name
-
Principal Investigator Name
Sören Westerholt
Principal Investigator Email
praxis@wob-doc.de
Contact Person Name
Sören Westerholt
Contact Person Email
praxis@wob-doc.de
Site Name
Barmherzige Brueder, Klinik Sankt Hedwig
Department Name
Klinik und Poliklinik für Kinder- und Jugendmedizin
Principal Investigator Name
Michael Kabesch
Principal Investigator Email
michael.kabesch@barmherzige-regensburg.de
Contact Person Name
Michael Kabesch

Sponsor

Primary sponsor

Full Name
INFECTOPHARM Arzneimittel und Consilium GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
GKM Gesellschaft fuer Therapieforschung mbH
Responsibilities
sponsorDuties codes: 1,5,6; contact: science@gkm-therapieforschung.de

Third parties

  • {"country":"Germany","full_name":"GKM Gesellschaft fuer Therapieforschung mbH","duties_or_roles":"sponsorDuties codes: 1,5,6; contact: science@gkm-therapieforschung.de","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
SanaCutan® Basiscreme
Active Substance
PARAFFIN WHITE SOFT
Modality
Other
Routes Of Administration
TOPICAL
Route
TOPICAL
Authorisation Status
Marketing authorisation details present (marketingAuthNumber: 12311.00.00) in DE
Maximum Dose
12 g per day (maxDailyDoseAmount)

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