NCT04398758 (MOPAD) is a Phase 3 clinical trial of SanaCutan Basiscreme in Atopic Dermatitis, sponsored by Infectopharm Arzneimittel GmbH.

Who is sponsoring NCT04398758?

NCT04398758 is sponsored by Infectopharm Arzneimittel GmbH.

What drugs are being tested in NCT04398758?

Interventions in NCT04398758: SanaCutan Basiscreme.

What condition does NCT04398758 study?

NCT04398758 studies Atopic Dermatitis, Infant, Newborn.

Is NCT04398758 still recruiting?

NCT04398758 is currently status unknown. Last updated 23 June 2022.

Last reviewed 2022-06-23 · How we verify

NCT04398758: MOPAD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prospective, Randomized, Non-treatment-controlled, Investigator-blinded, Multicenter Study on the Prophylaxis of Early Childhood Symptoms of Atopic Dermatitis in High-risk Children by Continuous Application of a Moisturizing Barrier-stabilizing Skin Cream

Status unknown Phase 3 Last updated 23 June 2022

What this trial tests

Phase 3 trial testing SanaCutan Basiscreme in Atopic Dermatitis in 360 participants. Status unknown.

Timeline

22 July 2020

Primary endpoint
1 December 2023

1 June 2024

Quick facts

Lead sponsor	Infectopharm Arzneimittel GmbH
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	360
Start date	22 July 2020
Primary completion	1 December 2023
Estimated completion	1 June 2024
Sites	10 locations across Germany

Drugs / interventions tested

SanaCutan Basiscreme — full drug profile →

Conditions studied

Atopic Dermatitis — all drugs for Atopic Dermatitis →
Infant, Newborn — all drugs for Infant, Newborn →

Sponsor

Infectopharm Arzneimittel GmbH — full company profile →

Who can join

Under 21 Days, any sex, with Atopic Dermatitis or Infant, Newborn. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Cumulative incidence of children with atopic dermatitis at 6 months of age
Time frame: 0-6 months of age
A confirmed atopic dermatitis is present if an atopic dermatitis is diagnosed in at least 2 examinations at intervals of at least 4 weeks (preliminary diagnosis + proof of chronification). The primary objective is achieved when the cumulative incidence of children with atopic dermatitis in the treatment group at 6 months of age is significantly lower than in the control group without predetermine

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Feast for thought: A comprehensive review of food allergy 2021-2023.
Bartha I, Almulhem N, Santos AF. · · 2024 · cited 74× · PMID 38101757 · DOI 10.1016/j.jaci.2023.11.918
Skin care interventions in infants for preventing eczema and food allergy.
Kelleher MM, Cro S, Cornelius V, Lodrup Carlsen KC, et al · · 2021 · cited 43× · PMID 33545739 · DOI 10.1002/14651858.cd013534.pub2
Skin care interventions in infants for preventing eczema and food allergy.
Kelleher MM, Phillips R, Brown SJ, Cro S, et al · · 2022 · cited 29× · PMID 36373988 · DOI 10.1002/14651858.cd013534.pub3

Verify or expand the search:

Other recruiting trials for Atopic Dermatitis

Currently open trials in the same condition.

NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi · Phase 1 · recruiting
NCT07445919 — A Clinical Study to Evaluate SM17 for Atopic Dermatitis · Phase 2 · recruiting
NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit · recruiting
NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · recruiting

Other Infectopharm Arzneimittel GmbH trials

Trials by the same sponsor.

NCT04552327 — 5% KOH Solution vs. Placebo and Diclofenac Gel for the Treatment of Actinic Keratosis · Phase 3 · completed
NCT04024579 — Treatment of Actinic Keratosis With 5% KOH Solution · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04398758 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Infectopharm Arzneimittel GmbH
Last refreshed: 23 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04398758.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing