To study the effect of the Physiological Regulating Medicine clinical manifestations in children with atopic dermatitis in a long time.

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 20.0Level: LLTClassification code 10013289Term: Disorders involving the immune mechanismSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-018640-13-IT
• Lead Sponsor: GUNA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified