Evaluation of Clinical Immunology of a long-term treatment with Physiological Regulating Medicine in a Pediatric Population suffering from chronic atopic dermatitis. Experimental study randomized double-blind two-stage - DERMOPED

GUNA S.P.A.0 sites128 target enrollmentJanuary 28, 2021

Overview

No summary available.

Registry

who.int

Start Date

January 28, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GUNA S.P.A.

•Included only children with atopic dermatitis mild to medium scale
•(Evaluated according to the index SCORAD, which must not exceed the value of 40, with
•minimum of 6\) score, with a number of relapses \= 4 / year and with the appearance of
•skin lesions of at least six months upon insertion in the study.
•· By setting up all the children must present an acute phase of the disease.
•· Included children with atopic dermatitis mediated IgE (specific tests in vivo and / or in vitro positive results) is not mediated IgE (specific tests in vivo and / orIn vitro negative results)
•Included in the study only children whose parents, or his deputy, read and signed informed consent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) no

•Will be excluded children with Atopic Dermatitis Severe (assessed
•SCORAD by index, with the index above 40\) value.
•· Will be excluded children with atopic dermatitis that at the time of selection
•have a phase of the disease remission.
•· Children who at the time of selection we have suspended for less than three months, therapy
•systemic and / or prolonged corticosteroids, antihistamines, calcineurin inhibitors
•(Tacrolimus and / or pimecrolimus) for topical use and specific immunotherapy.
•· Disorders associated with severe dermatitis.