Clinical Trials Register

Summary
EudraCT Number:	2013-004589-32
Sponsor's Protocol Code Number:	7724
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-04-03
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

UK - MHRA

A.2

EudraCT number

2013-004589-32

A.3

Full title of the trial

Bath Additives for the Treatment of cHildhood Eczema (BATHE)

A.3.1

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

BATHE: Bath Additives for the Treatment of cHildhood Eczema

A.3.2

Name or abbreviated title of the trial where available

BATHE

A.4.1

Sponsor's protocol code number

7724

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN84102309

A.5.4

Other Identifiers

Name:

EuDRACT

Number:

2013-004589-32

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	University of Southampton
B.1.3.4	Country
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	NIHR Health Technology Assessment
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University of Southampton
B.5.2	Functional name of contact point	Dr Miriam Santer
B.5.3	Address:
B.5.3.1	Street Address	Aldermoor Health Centre
B.5.3.2	Town/ city	Southampton
B.5.3.3	Post code	SO16 5ST
B.5.4	Telephone number	02380241019
B.5.5	Fax number	02380701125
B.5.6	E-mail	m.santer@soton.ac.uk

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	Oilatum Fragrance Free Junior
D.2.1.1.2	Name of the Marketing Authorisation holder	Stiefel
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Oilatum Fragrance Free Junior
D.3.2	Product code	not applicable
D.3.4	Pharmaceutical form	Bath additive
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Light Liquid paraffin BP
D.3.9.4	EV Substance Code	AS1
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	63.4%
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	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	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	Balneum bath oil
D.2.1.1.2	Name of the Marketing Authorisation holder	Almirall
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Balneum bath oil
D.3.2	Product code	not applicable
D.3.4	Pharmaceutical form	Bath additive
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Soya oil
D.3.9.4	EV Substance Code	AS2
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.3	Concentration number	84.75%
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)	Yes
	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	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	Aveeno bath oil
D.3.2	Product code	not applicable
D.3.4	Pharmaceutical form	Bath additive
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Colloidal oatmeal
D.3.9.4	EV Substance Code	AS3
D.3.10	Strength
D.3.10.3	Concentration number	not known
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)	Yes
	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Childhood Eczema

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	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10003641
E.1.2	Term	Atopic 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 determine the clinical and cost-effectiveness of bath emollient treatment, in addition to standard clinical care, for childhood eczema in primary care.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Children >1 year and <12 years with mild to severe eczema as defined by the UK Diagnostic Criteria for Atopic Eczema and with eczema severity at entry judged using the Nottingham Eczema Severity Scale (NESS).

E.4

Principal exclusion criteria

Very mild eczema (NESS score <5).
Child not using a bath at least once a week.
Carer (or child) not willing for child to be randomised to either 'bath emollient' or 'no bath emollient'.
Inability to give informed consent.
Insufficient English to complete outcome measures.
Already participating in the CREAM study led by Cardiff

E.5 End points

E.5.1

Primary end point(s)

POEM (Patient-Oriented Eczema Measure) is a patient reported outcome based on symptoms over the previous week which can be completed by the child’s carer. Our primary outcome measure is 'well controlled weeks', based on repeated measures of POEM data collected weekly over 16 weeks. This reflects the impact of this relapsing and remitting chronic condition better than comparing outcomes at a single follow-up point. Because of the burden of weekly data collection on participants we have limited weekly data collection to the first 16 weeks of the trial. Participants may choose to complete this either online or by post. If we receive no data after 16 weeks we will telephone to seek core outcome data by phone.

E.5.1.1

Timepoint(s) of evaluation of this end point

16 weeks

E.5.2

Secondary end point(s)

1. POEM (Patient-Oriented Eczema Measure) change from baseline at 12 months. (Carer report online or by post)

2. Number of eczema exacerbations resulting in a primary healthcare consultation in one year will be measured by GP record review. Exacerbations will be defined as consultations where there is mention of eczema and topical steroid has been advised or prescribed. (Records to examined by member of practice team or, if unable to do so, member of research team).

3. Number of GP appointments and dermatology referrals and prescribing for eczema will be assessed by GP record review. (Records to examined by member of practice team or, if unable to do so, member of research team).

4. Disease-specific quality of life (QoL), measured by DFI, IDQoL and CDLQI. DFI (Dermatitis Family Impact) is a widely-used validated instrument measuring impact of eczema on the family’s quality of life. IDQoL (Infants Dermatitis Quality of Life index) and CDLQI (Childrens Dermatology Life Quality Index) are validated measures in children aged 4 or less and 5 or over, respectively. (Carer report online or by post)

5. Generic QoL will be measured by CHU 9D. The CHU 9D (Child Health Utility 9D) is a paediatric preference-based utility measure exclusively developed with children aged 7-11 years and is more suitable for capturing quality of life impact related to atopic eczema. We believe the CHU 9D is the most appropriate measure for this study but it is relatively recently developed so we will also include HUI2 (Health Utility Index II) as it is the most widely used measure for children over 4 years of age. There are no suitable utility measures validated for very young children age 1-4 years. We therefore propose exploring the suitability of both measures in this age group and for atopic eczema, compared to the disease-specific measures. (Carer report online or by post)

6. Adherence to bath emollient reported by the carer will be asked weekly for the first 16 weeks and then monthly in the group allocated to bath emollient use. We will regularly ask both groups about use of bath emollients and other bath products, giving carers ‘permission’ to say if they have not been complying with treatment allocation, in order to measure contamination. (Carer report online or by post)

7. Adverse effects from bath emollients reported by carer will be asked at weekly for the first 16 weeks then monthly in the group allocated to bath emollient use. (Carer report online or by post)

8. Use of leave-on emollients, topical steroids (including potency) and topical calcineurin inhibitors will be monitored by carer report. (Carer report online or by post)

9. Service use (GP, Pharmacy, Walk-in centres, NHS direct) will be monitored by carer report using the CSRI (Client Service Receipt Inventory). (Carer report online or by post)

10. We will also measure expectation of benefit of bath emollients at baseline to be able to explore how much any effects seen might be due to expectation.

E.5.2.1

Timepoint(s) of evaluation of this end point

12 months

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)

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

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

Treatment as usual

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 follow up questionnaire completed online 12 months after last patient recruited.

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