Clinical Trials Register

Summary
EudraCT Number:	2011-004183-29
Sponsor's Protocol Code Number:	DERC-03
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-02-09
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

2011-004183-29

A.3

Full title of the trial

A randomised, placebo-controlled trial to investigate the effectiveness of an antimicrobial product in the elimination of Staphylococcus aureus colonisation from the anterior nares of adult subjects with atopic eczema. A proof of concept study (the NASSAELIM pilot).

A.3.1

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

A trial to investigate if use of an antimicrobial product in the nose of subjects with atopic eczema can remove colonisation with Staphylococcus aureus (a bacteria).

A.3.2

Name or abbreviated title of the trial where available

An antimicrobial product for removal of bacteria from inside the nose.

A.4.1

Sponsor's protocol code number

DERC-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	Dermal Laboratories
B.1.3.4	Country	United Kingdom
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	Dermal Laboratories
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	Dermal Laboratories
B.5.2	Functional name of contact point	Sykes
B.5.3	Address:
B.5.3.1	Street Address	Dermal Laboratories, Tatmore Place, Gosmore
B.5.3.2	Town/ city	Hitchin
B.5.3.3	Post code	SG4 7QR
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	01462 458866
B.5.5	Fax number	01462 420565
B.5.6	E-mail	krystyna.sykes@dermal.co.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	Dermol Cream
D.2.1.1.2	Name of the Marketing Authorisation holder	Dermal Laboratories
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	DERC
D.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Benzalkonium Chloride
D.3.9.1	CAS number	63449-41-2
D.3.9.4	EV Substance Code	AS3
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	0.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Chlorhexidine Dihydrochloride
D.3.9.1	CAS number	3697-42-5
D.3.9.4	EV Substance Code	AS4
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	0.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	isopropyl myristate
D.3.9.1	CAS number	110-27-0
D.3.9.4	EV Substance Code	AS7
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	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	liquid paraffin
D.3.9.1	CAS number	8012-95-1
D.3.9.4	EV Substance Code	AS8
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	10
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	Ointment
D.8.4	Route of administration of the placebo	Intranasal use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Nasal colonisation with Staphylococcus aureus

E.1.1.1

Medical condition in easily understood language

Bacteria which are found in the nostrils

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10069719
E.1.2	Term	Bacterial colonisation
E.1.2	System Organ Class	100000004862

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 principal objective is to determine whether the test cream is more effective than placebo(blank product)at removing Staphylococcus aureus bacteria from the nostrils of individuals with atopic eczema, when instilled into the nostrils 3 times daily for 7 days.

E.2.2

Secondary objectives of the trial

The secondary objective is to report on subjects' feedback on whether they find the product to be acceptable to use. The trial will also collect additional information on the rate of re-colonisation in the nose after discontinuing treatment and the percentage of MRSA-colonised patients (determined by nasal swab at Day 1 and 8) for whom eradication occurs on Day 8.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The principal inclusion criteria are as follows:

i) Adult subjects (aged 16 years and above) not meeting any of the exclusion criteria.

ii) Subjects diagnosed by the Investigator as having atopic eczema, as defined as;

a) Have an itchy skin condition within the past 12 months
plus at least three of the following:

b) History of flexural involvement
c) History of generally dry skin
d) Personal history of asthma or allergic rhinitis
e) Visible dermatitis involving skin creases
f) First onset of signs and symptoms as a child

iii) Subjects testing positive for the presence of Staphylococcus aureus in the anterior nares when swabbed on Day -7, with a colony count of greater than 1000 Colony Forming Units (CFU).

E.4

Principal exclusion criteria

The following subjects will be excluded from taking part in the study:

i) Subjects with a history of intolerance or skin sensitivity to any of the ingredients of the two IMPs.

ii) Subjects with infected eczema or any other infected skin condition.

iii) Subjects currently taking, or having taken within the 4 weeks prior to the study start (Day -7), any oral antibiotics, oral corticosteroids or oral immunosuppressants for acute conditions. Subjects that are taking low dose oral corticosteroids for long term, chronic conditions (such as arthritis, inflammatory bowel conditions) or using inhaled corticosteroids (for asthma or COPD) long term will be eligible if in the opinion of the Investigator their medication will not have any impact on the results of the trial.

iv) Subjects who are currently using or have used any topical antibiotics in the nose in the two weeks prior to the study start (Day -7).

v) Subjects who in the Investigator’s opinion would find nasal administration of the test IMP unacceptable or impracticable.

vi) Subjects with nasal piercings.

vii) Subjects with current allergic rhinitis, symptoms of cold or flu, nasal polyps or any damage to the nose.

viii) Subjects with systemic diseases which, in the opinion of the Investigator, may adversely influence their participation in the trial.

ix) Subjects who have received any unlicensed medicine within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study.

x) Subjects with current or recent heavy use of recreational drugs in the nose that may affect the nasal morphology.

xi) Female subjects who are pregnant or lactating (although there are no particular safety concerns in these subject groups, it is generally inappropriate for them to participate in clinical trials without overriding justification). Pregnancy testing is not deemed necessary and therefore will not be performed.

xii) Subjects considered unable or unlikely to adhere to the treatment regimen or attend the necessary follow-up visits.

xiii) Subjects with another member of the household already enrolled in the study, regardless of whether they have completed their participation. This is to avoid possible mix up between assigned IMPs and to avoid any subjects from seeing both of the study products which could affect blinding.

xiv) Subjects with planned elective surgery in the next 8 weeks that may require nasal decolonisation.

xv) Employees of Simbec, Dermal Laboratories or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of such employees.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy parameter will be the percentage of subjects whose nasal Staphylococcus aureus is eradicated by the 8th day (i.e. following 7 consecutive days of treatment), as determined by analysis of microbiological swabs for each treatment group. Any randomised subjects who were not confirmed as SA positive in the anterior nares at the Day 1 (pre-treatment) microbiological swabbing will not be included in the primary efficacy analysis.

E.5.1.1

Timepoint(s) of evaluation of this end point

Microbiological swabs will be taken on day 1 prior to treatment start and on day 8, following 7 days of treatment.

E.5.2

Secondary end point(s)

The secondary efficacy parameters will be the percentage of subjects reporting that the treatment regimen and method of application is acceptable.

E.5.2.1

Timepoint(s) of evaluation of this end point

Patients will record their opinion of the product in a patient questionnaire provided, which will be completed after their 7 days of applying the product.

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

Yes

E.6.13.1

Other scope of the trial description

Measurement of bacterial recolonisation rates.

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

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

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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