Clinical Trials Register

Summary
EudraCT Number:	2020-000720-19
Sponsor's Protocol Code Number:	IDI01/2020
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:	2021-05-24
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

2020-000720-19

A.3

Full title of the trial

A prospective, randomized, multicenter, open- label, two-arm and parallel-group Study to evaluate the efficacy and safety of Nicotinamide DS compared to Ciclopirox olamine cream at 1% in patients affected by seborrheic dermatitis.

Studio prospettico, randomizzato, multicentrico, in aperto, a due bracci e a gruppi paralleli, per valutare l'efficacia e la sicurezza di Nicotinamide DS rispetto al Ciclopirox olamina al 1% crema nei pazienti affetti da dermatite seborroica.

A.3.1

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

Study to evaluate the efficacy and safety of Nicotinamide DS compared to Ciclopirox olamine at 1% cream in seborrheic dermatitis.

Studio per valutare l'efficacia e la sicurezza di Nicotinamide DS crema rispetto al Ciclopirox olamina al1% crema nella dermatite seborroica.

A.3.2

Name or abbreviated title of the trial where available

IDI01/2020

A.4.1

Sponsor's protocol code number

IDI01/2020

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	IDI FARMACEUTICI SRL
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	IDI FARMACEUTICI SRL
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	Link Neuroscience and Health Care srl - L.N.Age srl
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Via Luigi Rizzo 62
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00136
B.5.3.4	Country	Italy
B.5.4	Telephone number	0639746749
B.5.5	Fax number	0631077733
B.5.6	E-mail	info@lnage.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Miclast 1% crema
D.2.1.1.2	Name of the Marketing Authorisation holder	Pierre Fabre Italia S.p.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Ciclopirox olamina 1% crema
D.3.2	Product code	[025218013]
D.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Ciclopirox olamina 1%
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
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	No
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.2.1.1.1	Trade name	Nicotinamide DS
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Nicotinamide DS
D.3.2	Product code	[05561]
D.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	05561
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
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	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients affected by seborrheic dermatitis.

Pazienti affetti da dermatite seborroica.

E.1.1.1

Medical condition in easily understood language

Patients affected by seborrheic dermatitis.

Pazienti affetti da dermatite seborroica.

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10039793
E.1.2	Term	Seborrhoeic dermatitis
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is the non-inferiority evaluation of the efficacy of Nicotinamide DS cream compared to 1% cream Ciclopirox olamine in reducing lesions in patients affected by seborrheic dermatitis estimated with the percentage of patients with lowering of the SASI index.

La valutazione di non inferiorità dell’efficacia di Nicotinamide DS crema rispetto al Ciclopirox olamina al 1% crema nella riduzione delle lesioni nei pazienti affetti da dermatite seborroica stimata con la percentuale dei pazienti che hanno avuto un abbassamento nei valori dell’indice SASI.

E.2.2

Secondary objectives of the trial

1. Amount of variation in SASI index.
2. Quality of life evaluation (Dermatology Life Quality Index - DLQI).
3. Evaluation of Malassezia colonization.
4. Evaluation of Staphylococcus epidermidis.
5. Itch evaluation Static(VAS scale).
6. Itch evaluation dynamic (Dynamic Pruritus Score).
7. S/AE or S/ADE.
8. Evaluation of dermoscopic pattern using super high magnification dermoscopy(400X)

1. Variazione dell'indice SASI.
2. Valutazione della qualità della vita (Dermatology Life Quality Index - DLQI).
3. Valutazione della colonizzazione di Malassezia.
4. Valutazione di Staphylococcus epidermidis.
5. Valutazione del prurito Statico (VAS Score).
6. Valutazione del prurito dinamico (Dynamic Pruritus Score).
7. S / AE o S / ADE.
8. Valutazione del modello dermoscopico mediante dermoscopia ad altissimo ingrandimento (400X).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and female, = 18 years;
2. Established diagnosis of seborrheic dermatitis of the face and scalp;
3. Able to co-operate and understand written and oral information;
4. Written informed consent.

1. Pazienti di sesso maschile e femminile, di età compresa =18 anni;
2. Diagnosi conclamata di dermatite seborroica del viso e cuoio capelluto;
3. In grado di cooperare e comprendere informazioni scritte e orali;
4. Consenso informato firmato.

E.4

Principal exclusion criteria

1. Concomitant dermatological diseases (eg acne, rosacea, contact dermatitis)
2. Recent use of treatments for seborrheic dermatitis (2 weeks for topical treatments; 4 weeks for systemic treatments);
3. Hypersensitivity to the active substance or to any of the excipients;
4. Established diagnosis of Actinic keratosis;
5. Established diagnosis of Parkinson;
6. Established diagnosis of HIV infection;
7. Use of immunesuppressant medications since last three months;
8. Established diagnosis of cardiac diseases;
9. Established diagnosis of alcoholic pancreatitis;
10. Established diagnosis of other neurological diseases;
11. Established diagnosis of Diabetic;
12. Pregnancy (positive pregnancy test for women of childbearing potential) and lactation;
13. Participation in any other clinical Study within 3 months prior to screening.

1. Malattie dermatologiche concomitanti (es. acne, rosacea, dematiti da contatto)
2. Recente uso di trattamenti per la dermatite seborroica (2 settimane per trattamenti topici; 4 settimane per trattamenti sistemici);
3. Ipersensibilità al principio attivo o ad uno qualsiasi degli ecipienti;
4. Diagnosi conclamata di Cheratosi attinica;
5. Diagnosi conclamata di Parkinson;
6. Diagnosi conclamata di infezione da HIV;
7. Uso di farmaci immunosoppressori dagli ultimi 3 mesi;
8. Diagnosi conclamata di malattie cardiache;
9. Diagnosi conclamata di pancreatite alcolica;
10. Diagnosi conclamata di altre malattie neurologiche;
11. Diagnosi conclamata di Diabete;
12. Gravidanza (test di gravidanza positivo per le donne potenzialmente fertili) e allattamento;
13. Partecipazione a qualsiasi altro studio clinico nei 3 mesi precedenti lo Screening.

E.5 End points

E.5.1

Primary end point(s)

Percentage of subject with better SASI index.

Percentuale di soggetto con un migliore indice SASI.

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit V1

Visita V1

E.5.2

Secondary end point(s)

1. Amount of variation in SASI index.
2. Dermatology Life Quality Index (DLQI).
3. Evaluation of Malassezia colonization.
4. Evaluation of Staphylococcus epidermidis.
5. VAS scale.
6. Dynamic Pruritus Score.
7. S/AEs and S/ADEs.
8. Evaluation of dermoscopic pattern using super high magnification dermoscopy (400X)

1. Variazione dell'indice SASI.
2. Indice di qualità della vita dermatologica (DLQI).
3. Valutazione della colonizzazione di Malassezia.
4. Valutazione di Staphylococcus epidermidis.
5. Scala VAS
6. Dynamic Pruritus Score.
7. S / AE e S / ADE.
8. Valutazione del modello dermoscopico mediante dermoscopia ad altissimo ingrandimento (400X).

E.5.2.1

Timepoint(s) of evaluation of this end point

The efficacy end points will be evaluated during Visit V1.
Maintenance and safety end points will be measured during the Visit V2.

Gli end point di efficacia saranno misurati durante la Visita V1.
Gli end point di mantenimento e sicurezza saranno misurati durante la Visita V2.

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

E.6.4

Safety

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

The Study is considered closed when all the e-CRFs are satisfactorily completed and the database is finally locked.

Lo studio è considerato chiuso quando tutti gli e-CRF sono completati in modo soddisfacente e il database è finalmente bloccato.

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

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)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

102

F.4.2

For a multinational trial

F.4.2.1

In the EEA

102

F.4.2.2

In the whole clinical trial

102

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)

At the discretion of the Investigator who follows the patient.

A discrezione dello Sperimentatore che segue il paziente.

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

2020-07-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-07-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-01-23

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