Clinical Trials Register

Summary
EudraCT Number:	2015-000881-73
Sponsor's Protocol Code Number:	35RC14_9754_PRADA
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:	2015-07-29
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

2015-000881-73

A.3

Full title of the trial

Multicentre, cross-over, PRAgmatic trial in Atopic Dermatitis testing long-term control effectiveness of new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation vs. placebo in a randomised, parallel-group trial

Etude PRAgmatique, multicentrique, en cross-over, évaluant chez des sujets atteints de Dermatite Atopique, l’efficacité sur le contrôle à long terme d’un nouveau protocole de photothérapie durant l’hiver, en traitement “add-on”, avec ou sans supplémentation en vitamine D dans un essai randomisé en groupe parallèle

A.3.1

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

PRAgmatic trial, Multicentre, cross-over, evaluating in patients with atopic dermatitis the long-term control effectiveness of new phototherapy regimen during winter, in supplement of standard topical treatmements, with oral vitamin D supplementation or not

Etude PRAgmatique, multicentrique, en cross-over, évaluant chez des sujets atteints de Dermatite Atopique, l’efficacité sur le contrôle à long terme d’un nouveau protocole de photothérpaie pendant l’hiver, en traitement supplémentaire aux traitements topiques standards, avec ou sans supplémentation en vitamine D

A.3.2

Name or abbreviated title of the trial where available

PRADA

A.4.1

Sponsor's protocol code number

35RC14_9754_PRADA

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 Rennes
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	Projet Hospitalier de Recherche Clinique
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 Rennes
B.5.2	Functional name of contact point	Visseiche
B.5.3	Address:
B.5.3.1	Street Address	2 rue Henri Le Guilloux
B.5.3.2	Town/ city	Rennes
B.5.3.3	Post code	35033
B.5.3.4	Country	France
B.5.4	Telephone number	33299 28 97 47
B.5.5	Fax number	33 2 99 28 37 22
B.5.6	E-mail	valerie.visseiche@chu-rennes.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	UVEDOSE
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratoires CRINEX
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	Vitamine D
D.3.4	Pharmaceutical form	Oral liquid
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	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	Oral solution
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 atopique

E.1.1.1

Medical condition in easily understood language

eczema

Eczéma

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	18.0
E.1.2	Level	HLT
E.1.2	Classification code	10012435
E.1.2	Term	Dermatitis and eczema
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

To evaluate a new phototherapy-based regimen as an add-on therapy (i.e., in addition to topical anti-inflammatory treatments) on atopic dermatitis long-term control in patients with atopic dermatitis aged 15 years or more with > 2 years of disease evolution, with moderate-to-severe disease (IGA > 2) in a primary care population in combination with vitamin D supplementation or not.

Evaluer un nouveau schéma de photothérapie en traitement add-on (en plus des traitements topiques standards) sur le contrôle à long terme de la dermatite atopique chez des patients âgés de 15 ans ou plus avec une dermatite atopique évoluant depuis plus de 2 ans, modérée à sévère (IGA > 2) pris en charge majoritairement en dermatologie de ville associé ou non à une supplémentation en vitamine D

E.2.2

Secondary objectives of the trial

- To compare vitamin D supplementation as an add-on therapy vs. placebo on long term efficacy control,
- To compare randomisation groups for all secondary outcome criteria (patient-reported outcomes, TAT consumption, quality of life, patient satisfaction, adverse events, and adherence to trial interventions) in winter and all-year-round,
- To explore the interplay and interaction between vitamin D and phototherapy on disease control and on serum vitamin D levels in winter and all-year-round,
- To describe patterns of disease and TAT consumption in relation with disease severity, and socio-demographic factors,
- To investigate temporal (seasonality) and regional differences for relevant outcome criteria,
- To assess the impact of regional weather and individual natural solar exposure on serum vitamin D levels in the context of presence or absence of vitamin D supplementation and phototherapy.

- Comparer une supplémentation en vitamine D en traitement “add-on”, au Placebo ;
- Comparer dans les groupes randomisés tous les critères de jugement secondaires (scores d’évaluation par le patient, consommation de dermocorticoïdes, qualité de vie, satisfaction du patient, effets secondaires, compliance au tt de l’étude) en hiver et tout au long de l’année ;
- Explorer les interactions entre la supplémentation en vitamine D et la photothérapie sur le contrôle de la DA et les taux de vitamine D l’hiver et tout au long de l’année.
- Décrire les différents aspects cliniques de la DA et relever la consommation de dermocorticoïdes en lien avec la sévérité de la DA et les facteurs socio-économiques ;
- Explorer les différences saisonnières et régionales sur les critères de jugement de l’étude ;
- Evaluer l’impact du climat et de l’exposition naturelle individuelle aux UV sur les taux de vitamine D en fonction de la supplémentation ou pas en vitamine D et de la photothérapie.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients with atopic dermatitis (Hanifin and Rajka criteria),
- Aged 15 years or more,
- With > 2 years of disease evolution,
- With moderate-to-severe disease (IGA > 2),
- Patients that have received TAT for at least 12 weeks and have symptoms requiring an increase in therapy,
- Seasonality in disease severity (based on a questionnaire assessing disease improvement during summer),
- Easy access to a phototherapy cabin (widely implanted in primary care dermatology private practice in France),
- Written informed consent of the patient
- For patients aged between 15 and 18, written informed consent of the parents and of the teenager.

- Patients avec une dermatite atopique (critères de Hanifin et Rajka),
- Agés de 15 ans ou plus,
- Dermatite atopique évoluant depuis au moins deux ans,
- Dermatite atopique modérée à sévère (IGA > 2),
- Patients ayant reçu des traitements topiques anti-inflammatoires (dermocorticoïdes ou tacrolimus topique) pendant au moins 12 semaines et dont les signes cutanés nécessitent une intensification du traitement,
- Sévérité de la dermatite atopique variable en fonction des saisons (sur la base d’un questionnaire évaluant l’amélioration pendant l’été),
- Accès facile à une cabine de photothérapie (largement implantée en dermatologie de ville),
- Signature d’un consentement éclairé par les patients,
- Signature d’un consentement éclairé par les parents et l’adolescent, chez les patients âgés de 15 à 18 ans.

E.4

Principal exclusion criteria

- Any cause of contra-indication for vitamin D supplementation: flare of granulomatosis, primary hyperparathyroidism,
- Clinical suspicion of hypercalciuria,
- Indication to a systemic immunosuppressant in the next 2 years,
- Atopic dermatitis known to be aggravated by UV exposure,
- Any contra-indication for artificial or solar exposure including: genetic diseases with a predisposition to skin cancer, any history of skin cancer (melanoma, squamous cell skin cancer, basal cell skin cancer), lupus, dermatomyositis, any other photosensitizing skin disease, photosensitizing medication),
- More than 100 previous phototherapy sessions in lifetime,
- Other trial standard exclusion criteria (pregnancy…),
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.

- Contre-indications à une supplémentation en vitamine D : poussée de granulomatose, hyperparathyroïdie primaire,
- Suspicion clinique d’hypercalciurie,
- Traitement par immunosuppresseur systématique envisagé dans les deux ans à venir,
- Dermatite atopique connue pour être aggravée par le soleil,
- Contre-indication à l’exposition aux UV naturels et superficiels : maladies génétiques prédisposant aux cancers cutanés, antécédents de cancers cutanés (mélanome, carcinome épidermoïde, carcinome basocellulaire), lupus, dermatomyosite, tout autre dermastose photosensible, traitement photosensibilisant),
- Plus de 100 séances de photothérapie réalisées,
- Autre contre-indication habituelle (grossesse, …),
- Personne sous protection légale (sauvegarde de justice, curatelle, tutelle),
- Personne privée de liberté.

E.5 End points

E.5.1

Primary end point(s)

Hierarchical criterion based on: (1) repeated measures of PO-SCORAD severity score over 1 year; (2) cumulative consumption of TAT (collected tubes) during winter.

Critère hiérarchique basé sur (1) des mesures répétées du score de sévérité du PO-SCORAD tout au long de l’année ; (2) consommation cumulée de traitements topiques anti-inflammatoires (tubes collectés) durant l’hiver.

E.5.1.1

Timepoint(s) of evaluation of this end point

PO-SCORAD: every month during 2 years
TAT consumption: every 3 months during 2 years

PO-SCORAD: tous les mois pendant 2 ans
Consommation TAT: tous les 3 mois pendant 2 ans

E.5.2

Secondary end point(s)

Repeated measures over 2 years for:
1 - Investigator-based severity scores (EASI, SCORAD, IGA)
2 - Patient-reported severity and quality of life validated scores (POEM, DLQI),
3 - Serum Vitamin D (25-(OH)-vitamin D) levels,
4 - Total IgE serum levels,
5 - Number of weeks of well-controlled AD,
6 - Inter-visit cumulative consumption TAT,
7 - Patient-reported satisfaction at the end of each winter.

Mesures répétées au cours des 2 ans de/des :
1 - Scores d’évaluation de la sévérité de la dermatite atopique par l’investigateur (EASI, SCORAD, IGA),
2 - Scores d’évaluation de la sévérité de la dermatite atopique par le patient et mesure de la qualité de vie (POEM, DLQI),
3 - Taux sérique de vitamine D (25-(OH)-vitamin D),
4 - Taux sérique d’IgE totales,
5 - Nombre de semaines avec une dermatite atopique bien contrôlée,
6 - Consommation cumulée de traitements topiques anti-inflammatoires entre chaque visite,
7 - Satisfaction du patient à la fin de chaque hiver

E.5.2.1

Timepoint(s) of evaluation of this end point

1 - every 3 months during 2 years
2 - POEM : every month during 2 years
DLQI : every 3 months during 2 years
3 - every 3 months during 2 years
4 - every 3 months during 2 years
5 - 2 years
6 - every 3 months during 2 years
7 - every year during 2 years

1 - tous les 3 mois pendant 2 ans
2 - POEM : tous les mois pendant 2 ans
DLQI : tous les 3 mois pendant 2 ans
3 - tous les 3 mois pendant 2 ans
4 - tous les 3 mois pendant 2 ans
5 - 2 ans
6 - tous les 3 mois pendant 2 ans
7 - tous les ans pendant 2 ans

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

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

Yes

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

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

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

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

last visit of the last patient

Dernière visite du dernier patient

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

150

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

200

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

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

2015-07-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-09

P. End of Trial
P.	End of Trial Status	Completed

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