Clinical Trials Register

Summary
EudraCT Number:	2012-004621-24
Sponsor's Protocol Code Number:	V00034CR3131B
National Competent Authority:	Estonia - SAM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-12-12
Trial results	View 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

Estonia - SAM

A.2

EudraCT number

2012-004621-24

A.3

Full title of the trial

Emollients in the management of atopic dermatitis in children: prevention of flares.

A.3.1

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

Emollients in the management of atopic dermatitis in children: prevention of flares.

A.3.2

Name or abbreviated title of the trial where available

Emollients in the management of AD

A.4.1

Sponsor's protocol code number

V00034CR3131B

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	PIERRE FABRE MEDICAMENT
B.1.3.4	Country	France
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	PIERRE FABRE MEDICAMENT
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	PIERRE FABRE MEDICAMENT
B.5.2	Functional name of contact point	Carine FABRE
B.5.3	Address:
B.5.3.1	Street Address	3 avenue Hubert Curien
B.5.3.2	Town/ city	TOULOUSE
B.5.3.3	Post code	31035
B.5.3.4	Country	France
B.5.4	Telephone number	+33534506357
B.5.5	Fax number	+33534506592
B.5.6	E-mail	carine.fabre@pierre-fabre.com

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	DEXERYL
D.2.1.1.2	Name of the Marketing Authorisation holder	PIERRE FABRE MEDICAMENT
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	DEXERYL
D.3.2	Product code	V0034CR
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.3.8	INN - Proposed INN	Glycerol
D.3.9.1	CAS number	56-81-5
D.3.9.3	Other descriptive name	GLYCEROL
D.3.9.4	EV Substance Code	SUB07948MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	White soft paraffin
D.3.9.1	CAS number	8000026-37-1
D.3.9.3	Other descriptive name	WHITE SOFT PARAFFIN
D.3.9.4	EV Substance Code	SUB15722MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PARAFFIN LIQUID
D.3.9.2	Current sponsor code	V0049
D.3.9.3	Other descriptive name	Paraffin liquid
D.3.9.4	EV Substance Code	SUB30031
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Atopic dermatitis

E.1.1.1

Medical condition in easily understood language

Atopic dermatitis

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10003639
E.1.2	Term	Atopic dermatitis
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 assess the ability of DEXERYL to prevent flares after treatment of a previous flare by a topical corticosteroid.

E.2.2

Secondary objectives of the trial

To assess the time to first flare, the number of flares
To evaluate the consumption of topical corticosteroid
To evaluate DEXERYL effect on the skin dryness and pruritus
To evaluate DEXERYL on the subjective perception of the skin
To document the clinical, local and systemic, safety of DEXERYL

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients, male or female children, presenting with the following criteria may be included (V1):
Age between 2 and 6 years included,
- Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working Party,
- Who has presented within the previous 6 months at least one duly documented flare treated by corticosteroids,
- Who present a current flare,
- Whose objective SCORAD score is [15-40] (grade 3) at inclusion,
- Whose parent(s) or guardian(s) has given his/her (their) written consent for their child's participation in the study,
- Whose parent(s) or guardian(s) is (are) cooperative with regard to compliance with study-related constraints,
- Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation).
After treatment of the current flare, patients should have for randomization (V2):
- Objective SCORAD score is < 15,
- No lichenification, no excoriation, no oozing/crusts, no oedema/papulation,
- Erythema intensity < 1 (residual erythema area ≤ 10% of extent),
- Xerosis intensity> 1,
- No pruritus, no sleep disorders (< 1 on VAS of SCORAD).
If lesions are not cleared in 21 days, patient cannot be randomized.

E.4

Principal exclusion criteria

* Criteria related to pathologies
- Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
- Primary bacterial, viral, fungal or parasitic skin infection,
- Ulcerated lesions, acne or rosacea,
- Dermatological disease other than atopic dermatitis which could interfere with the assessment,
- Immunosuppression,
- History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.
* Criteria related to treatments
- Use of oral corticosteroids or immunosuppressants during the last 14 days,
- Use of topical corticosteroids during the last 7 days,
- Use of systemic or local antibiotics on the lesions during the last 7 days,
- Use of non-steroid anti-inflammatory drugs or antihistamines during the last 7 days,
- Regular use of food supplements that could, in the opinion of the investigator, modify skin properties (e.g. synbiotics),
- History of hypersensitivity or intolerance to one of the components of the tested or associated products, or to cosmetics.

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients with at least one flare assessed by the investigator over the 12 weeks of treatment
In case of occurrence of flare, the patient should be seen as soon as possible by the investigator to confirm the flare, and if necessary to prescribe appropriate treatments.
A flare will be defined as following : measurable increased extent or intensity of lesions in less than 2 weeks under continued treatment (in this case: emollient or no emollient), corresponding to a significant increase (> 25%) in medical score (SCORAD or last PO-SCORAD) or to the introduction of a new line of therapy (topical corticosteroid), and reported in the Adverse Event section of the Case Report Form.
Should be considered as 2 separate flares, if topical corticosteroid is interrupted during at least 7 days (absence of inflammatory symptoms); otherwise symptoms will be considered as a single flare.

E.5.1.1

Timepoint(s) of evaluation of this end point

D28, D56, D84

E.5.2

Secondary end point(s)

• Time to first flare assessed by the investigator over the 12 weeks of treatment
• Number of patients in complete remission defined as a period without flare of at least 8 weeks without anti-inflammatory treatment (avoidance of irritants / allergens and emollients not included)
• Number of patients needing corticosteroids or immunosuppressants over the 12 weeks of treatment
• Consumption of corticosteroid: number of days of application, weight of corticosteroid used
• Xerosis score (from SCORAD) over the 12 weeks of treatment
• Pruritus score (VAS from SCORAD) over the 12 weeks of treatment
• Sleep loss score (VAS from SCORAD) over the 12 weeks of treatment
• SCORAD and objective SCORAD scores assessed by the investigator at every visit over the 12 weeks of treatment
• PO-SCORAD (Patient Oriented SCORAD) score assessed twice weekly by the parents over the 12 weeks of treatment
• IGA (Investigator Global Assessment) assessed by the investigator at every visit over the 12 weeks of treatment
• POEM score (Patient-Oriented Eczema Measure) assessed weekly by parents over the 12 weeks of treatment
• Assessment of the local tolerability (examination of the skin) and the systemic safety (general clinical examination and reported adverse events).
• Overall assessment of treatment use by the parents on a 4 point scale at 12th week (only for patients treated by one of 2 emollients).

E.5.2.1

Timepoint(s) of evaluation of this end point

D28, D56, D84

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

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)

Yes

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

No treatment (arm n°2).Atopiclair (arm n°3) is a class IIa authorised MD used as a positive control.

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

Yes

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

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

Number of subjects for this age range:

409

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:

409

F.1.1.6

Adolescents (12-17 years)

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

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Consent is given by the parent(s) or guardian(s) beacause child aged 2 to 6.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

409

F.4.2.2

In the whole clinical trial

409

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

2013-01-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-02-12

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