STEADY

Project title: Prospective, randomized, open-label Phase III clinical trial with blinded endpoint assessing the efficacy and safety of ciclosporin and methotrexate in children and adolescents with moderate to severe atopic dermatitis.

Project data

Project financing: 16 016 547,36 PLN , financed by the Medical Research Agency (ABM) - ABM/2019/1

Project description:

The project aims to evaluate the efficacy and safety of methotrexate and cyclosporine usage for children with AD (Atopic Dermatitis) by assessing the effects of the drugs on lesion severity, laboratory parameters, internal organ function and quality of life. We believe that these interventions will improve the health of children with AD, including the emotional and psychological aspects.

ATOPIC SKIN DISEASE (AD) is a chronic inflammatory skin disease that is more common in children than in adults. Currently available therapies do not offer a cure for AD, and the drugs used only result in remission of skin lesions and the subjective symptoms. The current mainstay of AD treatment is topical therapy, which is not always sufficient to control moderate to severe AD in some patients, who may require systemic treatment to achieve sufficient symptom control. This is why it is so important to evaluate the efficacy and safety of classic immunosuppressive drugs such as cyclosporine or methotrexate in children and adolescents with moderate to severe AD who require systemic treatment.

Beneficiary

Medical University of Lodz

Coordinating Principal Investigator

Prof. Joanna Narbutt, MD, PhD

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