A randomized, double-blind, placebo-controlled, multicenter clinical trial investigating the efficacy and safety of Dermasectan® vs. placebo administered to adult patients with atopic dermatitis (AD)

ovintethical Pharma (Switzerland)0 sites42 target enrollmentNovember 24, 2021

Overview

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37560506/ (added 11/08/2023)

Registry

who.int

Start Date

November 24, 2021

End Date

May 2, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

ovintethical Pharma (Switzerland)

•1\. Adult subjects, 18 years or older
•2\. Subject willing to sign the informed consent
•3\. AD diagnosed at screening visit
•4\. Clinical digital photography to provide images of affected and healthy skin
•5\. Willing and able to comply with all clinic visits and study\-related criteria

•1\. The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment:
•1\.1 Systemic corticosteroids
•1\.2 Immunosuppressive/immunomodulating drugs
•1\.3 Phototherapy for AD
•2\. Treatment with certain biologics
•3\. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit
•4\. Planned major surgical procedure during the patient's participation in this study
•5\. Patient is a member of the investigational team or his/her immediate family
•6\. Pregnant or breast\-feeding women or women planning to become pregnant or breastfeed during the study
•7\. Hypersensitivity to any of the ingredients of the study agents.