Atopic dermatitis MedDRA version: 20.0 Level: LLT Classification code 10013289 Term: Disorders involving the immune mechanism System Organ Class: 100000004870
Conditions
Interventions
Product Name: GUNA-INTERFERON GAMMA
Pharmaceutical Form: Oral drops, solution
Route of administration of the placebo: Oral use
Product Name: GUNA-INTERLEUKIN 12
Pharmaceutical Form: Oral drops, solut
Sponsors
GUNA S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of a long-term treatment with Physiological Regulation Medicine in chronic atopic dermatitis by SCORAD index.;Secondary Objective: disease-free interval elongation;Primary end point(s): Reduction in the severity of atopic dermatitis, as assessed by SCORAD index.;Timepoint(s) of evaluation of this end point: 23 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ¿ Extension of the "disease-free interval". ¿ Compliance and tolerability of the treatment and management of adverse events. ¿ Skin Prick Test to major inhalant and food allergens. ¿ Skin Prick by Prick Test to major food allergens. ¿ Patch Test to major food allergens, to the Acari and Nickel. ¿ Total and specific IgE to major inhalant and food allergens. ¿ Characterization of lymphocyte subpopulations by flow cytometry using battery monoclonal antibodies.;Timepoint(s) of evaluation of this end point: 23 months | — |
Countries
Italy
Contacts
Public ContactUnit¿ di Ricerca Clinica
Guna S.p.a.
Outcome results
None listed