Clinical Trials Register

Summary
EudraCT Number:	2010-018640-13
Sponsor's Protocol Code Number:	DERMOPED_001_DA_ISS
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-01-28
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2010-018640-13

A.3

Full title of the trial

"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"

"Valutazione Clinico-Immunologica di un trattamento long-term con Medicina Fisiologica di Regolazione in una Popolazione Pediatrica affetta da Dermatite atopica cronica. Studio sperimentale randomizzato in doppio cieco a due stadi¿

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Studiare l'effetto della Medicina Fisiologica di Regolazione sulle manifestazioni cliniche in bambini affetti da dermatite atopica in un lungo periodo.

A.3.2

Name or abbreviated title of the trial where available

DERMOPED

A.4.1

Sponsor's protocol code number

DERMOPED_001_DA_ISS

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GUNA S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Guna S.p.a.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Guna S.p.a.
B.5.2	Functional name of contact point	Unit¿ di Ricerca Clinica
B.5.3	Address:
B.5.3.1	Street Address	Via Palmanova 71
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20132
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 02 28018335
B.5.5	Fax number	+39 02 28018340
B.5.6	E-mail	clinical@guna.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	GUNA-INTERFERON GAMMA
D.3.4	Pharmaceutical form	Oral drops, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	Yes
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	GUNA-INTERLEUKIN 12
D.3.4	Pharmaceutical form	Oral drops, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	Yes
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Atopic dermatitis

Dermatite Atopica

E.1.1.1

Medical condition in easily understood language

Atopic dermatitis

Dermatite atopica

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10013289
E.1.2	Term	Disorders involving the immune mechanism
E.1.2	System Organ Class	100000004870

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To study the effect of a long-term treatment with Physiological Regulation Medicine in chronic atopic dermatitis by SCORAD index.

Studiare l'effetto di un trattamento long-term con medicina fisiologica di regolazione nella dermatite atopica cronica attraverso l'indice SCORAD

E.2.2

Secondary objectives of the trial

disease-free interval elongation

Allungamento del disease-free interval

E.2.3

Trial contains a sub-study

E.3

Principal 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.

Inclusi solo bambini affetti da Dermatite Atopica di entità lieve-media (valutata in base all’indice SCORAD, che non dovrà superare il valore di 40, con punteggio minimo di 6), con un numero di recidive = 4/anno e con comparsa delle
lesioni cutanee da almeno sei mesi all’atto dell’inserimento nello studio.
· All’atto dell’inserimento tutti i bambini dovranno presentare una fase acuta della
malattia.
· Verranno inclusi bambini affetti da Dermatite Atopica sia IgE mediata (test specifici
in vivo e /o in vitro risultati positivi) sia non IgE mediata (test specifici in vivo e /o
in vitro risultati negativi)
· Saranno inseriti nello studio solo i bambini i cui genitori, o chi ne fa le veci , avranno
letto e firmato entrambi il Consenso Informato.

E.4

Principal 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.

· Verranno esclusi i bambini affetti da Dermatite Atopica di entità grave (valutata in
base all’indice SCORAD, con indice superiore al valore di 40).
· Verranno esclusi i bambini affetti da Dermatite Atopica che all’atto della selezione
presentano una fase di remissione della malattia.
· Bambini che all’atto della selezione abbiamo sospeso da meno di tre mesi la terapia
sistemica e/o prolungata con corticosteroidi, antistaminici, inibitori della calcineurina
(tacrolimus e/o pimecrolimus ) per uso topico ed Immunoterapia specifica .
· Patologie sistemiche severe associate alla dermatite.

E.5 End points

E.5.1

Primary end point(s)

Reduction in the severity of atopic dermatitis, as assessed by SCORAD index.

Riduzione della gravità della Dermatite Atopica, valutata secondo l’indice SCORAD.

E.5.1.1

Timepoint(s) of evaluation of this end point

23 months

23 mesi

E.5.2

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.

¿ Allungamento del ¿disease¿free interval¿ .
¿ Tollerabilit¿ e compliance del trattamento e gestione degli eventi avversi.
¿ Skin Prick Test verso i principali allergeni inalanti ed alimentari.
¿ Skin Prick by Prick Test verso i principali allergeni alimentari.
¿ Patch Test verso i principali allergeni alimentari, verso gli Acari ed il Nichel.
¿ IgE totali e specifiche verso i principali allergeni inalanti ed alimentari.
¿ Caratterizzazione delle sottopopolazioni linfocitarie in citofluorimetria mediante batteria di
anticorpi monoclonali.

E.5.2.1

Timepoint(s) of evaluation of this end point

23 months

23 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

128

F.4.2

For a multinational trial

F.4.2.1

In the EEA

128

F.4.2.2

In the whole clinical trial

128

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

The subjects are monitored for a period of one year after the trial

I soggetti vengono monitorati per un periodo di un anno dopo la sperimentazione

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2009-10-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-10-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-03-15

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