Clinical Trials Register

Summary
EudraCT Number:	2018-001371-20
Sponsor's Protocol Code Number:	18-PP-03
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-04-11
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

France - ANSM

A.2

EudraCT number

2018-001371-20

A.3

Full title of the trial

Study of the role of local treatments on the modulation of the microbiome in psoriatic skin

Etude du rôle des traitements locaux sur la modulation du microbiome dans la peau psoriasique

A.3.1

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

Microbiome & Psoriasis Study

Etude microbiome & psoriasis

A.3.2

Name or abbreviated title of the trial where available

Microbiome & Psoriasis Study

Etude microbiome & psoriasis

A.4.1

Sponsor's protocol code number

18-PP-03

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	CHU de Nice
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	CHU de Nice
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CHU de Nice
B.5.2	Functional name of contact point	DRCI
B.5.3	Address:
B.5.3.1	Street Address	4 avenue Reine Victoria
B.5.3.2	Town/ city	Nice
B.5.3.3	Post code	06003
B.5.3.4	Country	France
B.5.4	Telephone number	04 92 03 40 11+33
B.5.6	E-mail	drc@chu-nice.fr

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	Yes
D.2.1.1.1	Trade name	ENSTILAR
D.2.1.1.2	Name of the Marketing Authorisation holder	LEO PHARMA
D.2.1.2	Country which granted the Marketing Authorisation	France
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	ENSTILAR
D.3.4	Pharmaceutical form	Cutaneous foam
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	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	DERMOVAL
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATOIRE GLAXOSMITHKLINE
D.2.1.2	Country which granted the Marketing Authorisation	France
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	DERMOVAL
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.3.11 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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 3
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	DIPROSONE
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD FRANCE
D.2.1.2	Country which granted the Marketing Authorisation	France
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	DIPROSONE
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.3.11 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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Cutaneous foam
D.8.4	Route of administration of the placebo	Cutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Psoriasis

E.1.1.1

Medical condition in easily understood language

Psoriasis

E.1.1.2

Therapeutic area

Body processes [G] - Cell Physiological Phenomena [G04]

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	10050576
E.1.2	Term	Psoriasis vulgaris
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Compare the respective effects of the combination betamethasone-calcipotriol mousse:
1) Versus the placebo foam,
2) Versus betamethasone cream (DIPROSONE),
3) Versus the clobetasol propionate (DERMOVAL) cream,
on the cutaneous microbiome of psoriasis lesions and surrounding healthy skin after 4 weeks of treatments

Comparer les effets respectifs de l’association bétaméthasone-calcipotriol mousse:
1) Versus la mousse placebo,
2) Versus la bétaméthasone crème (DIPROSONE),
3) Versus le propionate de clobétasol (DERMOVAL) crème,
sur le microbiome cutané de lésions de psoriasis et sur la peau saine environnante après 4 semaines de traitements.

E.2.2

Secondary objectives of the trial

1. Evaluate the relative efficacy of the products on psoriasis lesions,
2. Assess tolerance and adverse effects,
3. Evaluate the impact of treatments on lymphoid innate cells (number and relative proportion in the 3 types of ILC) and natural killer cells (NKs) in lesions and their potential correlation with microbiome modification.

1. Evaluer l'efficacité relative des produits sur les lésions de psoriasis,
2. Evaluer la tolérance et les effets indésirables,
3. Evaluer l'impact des traitements sur les cellules innées lymphoïdes (nombre et proportion relative dans les 3 types d’ILC) et sur les cellules tueuses naturelles (NKs) dans les lésions et leur corrélation potentielle avec la modification du microbiome.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients of both more than 18-year-old sexes having signed and dated a form of information and informed consent.
2. Subject presenting a psoriasis vulgaris with symmetric hurts in size and in severity, located on elbows and\or knees and having a score of severity (PASI)< 10. The hurts will have to have a surface of at least 4 cms ².

1. Patients des deux sexes âgés de plus de 18 ans ayant signé et daté un formulaire d’information et de consentement éclairé.
2. Sujet présentant un psoriasis vulgaris avec des lésions symétriques en taille et en sévérité, localisées sur les coudes et/ou les genoux et ayant un score de sévérité (PASI) <10. Les lésions devront avoir une surface d’au moins 4 cm².

E.4

Principal exclusion criteria

1. Subject presenting a psoriasis in drop(gout), érythrodermique, exfoliatif or pustuleux.
2. Feminine Subject pregnant or breast-feeding.
3. Subject having received a systematic treatment(processing) and having a potential action(share) on the psoriasis vulgaris (ex: phototherapy, cyclosporine, méthotrexate, biotherapics, steroids, or other immunosuppresseurs treatments(processings)) in 2 months preceding the randomization and during all the duration the study.
4. Subject having received a treatment(processing) antibiotic in the previous three months the visit of inclusion
5. Subject having received the topical treatments(processings) (example: corticostéroïdes, tazarotène, analogues of the vitamin D) or neutral emollients in 4 weeks preceding the randomization

1. Sujet présentant un psoriasis en goutte, érythrodermique, exfoliatif ou pustuleux.
2. Sujet féminin enceinte ou allaitante.
3. Sujet ayant reçu un traitement systémique et ayant une action potentielle sur le psoriasis vulgaris (ex : photothérapie, cyclosporine, méthotrexate, biothérapies, stéroïdes, ou autres traitements immunosuppresseurs) dans les 2 mois précédant la randomisation et pendant toute la durée de l’étude.
4. Sujet ayant reçu un traitement antibiotique dans les trois mois précédents la visite d’inclusion
5. Sujet ayant reçu des traitements topiques (exemple : corticostéroïdes, tazarotène, analogues de la vitamine D) ou des émollients neutres dans les 4 semaines précédant la rando

E.5 End points

E.5.1

Primary end point(s)

Quantitative and qualitative evaluation of bacterial microbiota on psoriasis lesions and surrounding healthy skin by 16S rRNA amplification coupled with high throughput sequencing.

Évaluation quantitative et qualitative du microbiote bactérien sur les lésions de psoriasis et sur la peau saine environnante par amplification ARNr 16S couplée au séquençage haut débit.

E.5.2

Secondary end point(s)

- PASI for the effectiveness of the products tested.
- Number and types of ILCs and NKs on skin biopsies using immunohistochemistry
- Overall evaluation of the investigator's treatment (PGA) after 4 weeks of treatment.
- Evaluation of the tolerance after 4 weeks of treatment.
- Study the occurrence of possible adverse effects

- PASI pour l’efficacité des produits testés.
- Nombre et types de ILCs et de NKs sur les biopsies cutanées par immunohistochimie
- Evaluation globale des traitements par l’Investigateur (PGA) après 4 semaines de traitement.
- Evaluation de la tolérance après 4 semaines de traitement.
- Etudier la survenue d’éventuels effets indésirables

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

E.6.5

Efficacy

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

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

ENSTILAR

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.8.5

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

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

None

Non

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

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

Yes

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

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)

None

Non

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

2018-06-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-05-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-03-07

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