Clinical Trials Register

Summary
EudraCT Number:	2011-004184-79
Sponsor's Protocol Code Number:	NIAD-01
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:	2013-04-30
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

2011-004184-79

A.3

Full title of the trial

A placebo controlled evaluation of a developmental gel for the treatment of atopic eczema

A.3.1

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

A topical gel for the treatment of atopic eczema

A.3.2

Name or abbreviated title of the trial where available

NIAD-01: A topical gel for the treatment of atopic eczema

A.4.1

Sponsor's protocol code number

NIAD-01

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 Limited
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dermal Laboratories Limited
B.5.2	Functional name of contact point	Amanda Wigens
B.5.3	Address:
B.5.3.1	Street Address	Dermal Laboratories
B.5.3.2	Town/ city	Gosmore
B.5.3.3	Post code	SG4 7QR
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	01462458866
B.5.5	Fax number	01462438707
B.5.6	E-mail	clinical@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	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	NIAD Gel
D.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent) Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Nicotinamide
D.3.9.1	CAS number	98-92-0
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	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.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	Gel
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

The medical condition to be investigated in this study is atopic eczema, also known as atopic dermatitis.

E.1.1.1

Medical condition in easily understood language

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	20.0
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

This is essentially a proof of concept study to find out whether the 4% nicotinamide gel offers therapeutically relevant treatment of mild to moderate atopic eczema.

If the active gel is beneficial in treating the very itchy, red and inflamed ‘flared’ atopic eczema skin areas, this may help us develop a new product which can help reduce the impact of atopic eczema on the lives of patients and their families.

E.2.2

Secondary objectives of the trial

We are interested in gathering as much information as possible about how the study gels affect the skin of patients with atopic eczema. For this reason, several secondary clinical outcomes, as well as additional clinical outcomes, comprising measures of local flare severity and the patient self-reported assessment of itchiness on the treated areas of the inner forearms, are also included in this trial.

Additional patient reported outcomes are also included in order to collect feedback from the patients themselves regarding their satisfaction with the physical aspects of the study gels, or not as the case may be. This is a very important aspect of any topically applied medicine; especially for a chronic condition such as atopic eczema.

The research methodology being employed in this study also includes a number of exploratory outcomes evaluating the effects of the study gels on the skin barrier function, aiming to provide a better understanding of the mode of action of the active

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

i) Male or female patients aged 16 years or older.

ii) Diagnosed as having atopic eczema as determined according to the UK Working Party's Diagnostic Criteria.

iii) Experiencing a mild to moderate acute episode (or flare) including bilaterally symmetrical involvement of the volar aspects of the forearms (including the flexures), presenting a local Investigator Global Assessment (IGA) score of 2 or 3 (see section 1.9) and an involvement area of at least 20 to 25 cm2 (approximately half of the size of a credit card).

iv) Willing to refrain from using any other topical treatments as well as emollients or moisturisers on the entire area of the volar forearms (from the front of the wrists to just above the creases of the elbows) for the next 29 days. Patients will be permitted to continue using prescribed topical treatments required for managing atopic eczema (including topical immunosuppressants) in other non-study areas of the body.

E.4

Principal exclusion criteria

i) Patients with a history of intolerance or skin sensitivity to any of the ingredients.

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

iii) Patients with severe atopic eczema (IGA≥4) and/or with any active skin infections in the selected target areas.

iv) Patients with more than 20% of total body surface area of involvement (i.e. area equivalent to the whole of both arms or the whole of one leg).

v) Patients who have had phototherapy (UVB, PUVA) or systemic therapy with corticosteroids and / or other immunosuppressants, or cytostatics, within 4 weeks prior to screening.

vi) Patients who have taken systemic antibiotics within 2 weeks prior to screening.

vii) Patients who have applied topical treatments (e.g. tar, corticosteroids) on the study areas within 7 days prior to screening (with the exception of topically applied emollients).

viii) Patients receiving other medication known to alter the course of atopic eczema during the study (e.g. oral corticosteroids and/or other oral immunosuppressants).

ix) Patients who have received any unlicensed drug 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) Female patients who are pregnant, attempting to conceive or not currently using a contraceptive, or lactating (although there are no particular safety concerns in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification. Negative pregnancy testing will not be necessary, and there are no safety concerns, as such, about female subjects potentially conceiving while taking part in the study).

xi) Patients considered unable or unlikely to attend the necessary follow-up visits.

xii) Patients with another member of the household already enrolled in the study (this is to avoid possible mix up between assigned treatments).

xiii) Patients with tattoos, scars and/or birthmarks on the study treatment areas, which could potentially interfere with the visual assessments and/or the objective skin measurements performed in this study.

xiv) Patients with temporary or permanent impaired function of either left or right hands/arms such that they would be unable to apply the test products correctly to both arms themselves, and who cannot rely on external help (e.g. a relative or carer) to do so for them.

xv) Employees of Alba Science or 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 outcome measure for the study will be the difference between the change from baseline in the Investigator Global Assessment (IGA) for the area treated with the active gel compared to the area treated with the placebo gel, at the end of the 4 week treatment period. IGA will be scored by the Investigator using the following 6 point scoring system: 0 = absent; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe; 5 = very severe.

E.5.1.1

Timepoint(s) of evaluation of this end point

IGA will be measured on both treatment areas at baseline (i.e. before treatment) and after 4 weeks of treatment.

E.5.2

Secondary end point(s)

1. Three Item Severity Score (TISS)
This secondary efficacy parameter will be the change from baseline in the TISS, which is the sum of the three individual SCORAD intensity scores of erythema, oedema/papulation and excoriation at the end of the 4 week treatment period for the areas treated with the active gel compared with the placebo treated areas. Each of these SCORAD intensity items will be scored by the Investigator using the following 4 point scoring system: 0 = absent; 1 = mild; 2 = moderate; 3 = severe.

2. Percentage of patients with Investigator Global Assessment (IGA) of 0 (clear) or 1 (almost clear)
For this secondary outcome, the Investigator will calculate the percentage of patients with Investigator Global Assessment (IGA) of 0 (clear) or 1 (almost clear) at the end of the 4 week treatment period for the areas treated with the active gel compared with the placebo. The IGA will be assessed by the Investigator on the treated forearms as primary efficacy parameter for this trial.

3. Patient self-assessment of pruritus
This secondary outcome refers to the change from baseline in patient self-assessment of pruritus at the end of the 4 week treatment period for the areas treated with the active gel compared with the placebo treated areas. Patients will grade the intensity of pruritus on each treatment area using the following 6 point categorical scale: 0 = none; 1 = mild; 2 = moderate; 3 = marked; 4 = severe; 5 = intense.

4. Patient self-assessment of relative itchiness
This is related to the percentage of blinded patients reporting that the area treated with the active gel was less itchy than the area treated with the placebo gel, at the end of the 4 week treatment period. Patients will be asked to compare the degree of itching between the two left / right areas on a 5 point comparative scale: 1 = the left side study area itches considerably more than the right; 2 = the left side study area itches slightly more than the right; 3 = both sides itch the same; 4 = the right side study area itches slightly more than the left; 5 = the right side study area itches considerably more than the left.

The safety aspects (adverse events) of the investigational products for use in patients with atopic eczema will also be evaluated throughout the clinical trial as an additional clinical outcome.A number of other exploratory additional clinical and patient-reported outcomes, as well as exploratory skin barrier function measurements, are also included in this trial.

E.5.2.1

Timepoint(s) of evaluation of this end point

All secondary endpoints will be evaluated on both treatment areas at baseline (i.e. before treatment) and after 4 weeks of treatment. Exploratory (additional) clinical and barrier function outcomes (i.e. TEWL) will be evaluated also after 2 weeks (interim assessment).

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

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)

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

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.8.6 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