Clinical Trials Register

Summary
EudraCT Number:	2012-003739-44
Sponsor's Protocol Code Number:	DS107E-02
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-12-04
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2012-003739-44

A.3

Full title of the trial

A Randomised, Double-blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Topically Applied DGLA Cream in Patients with Mild to Moderate Atopic Dermatitis

Randomizált, kettős-vak, placebo-kontrollos, II. fázisú vizsgálat a helyileg alkalmazott DGLA krém hatékonyságának és biztonságosságának értékelésére enyhe és középsúlyos atopiás
dermatitisben szenvedő betegeknél

A.3.1

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

Safety and Efficacy Study of DGLA Cream in Patients with Atopic Dermatitis

A DGLA krém hatékonysági és biztonságossági vizsgálata atopiás dermatitisben szenvedő betegeknél

A.3.2

Name or abbreviated title of the trial where available

Safety and Efficacy Study of DGLA Cream in Patients with Atopic Dermatitis

A DGLA krém hatékonysági és biztonságossági vizsgálata atopiás dermatitisben szenvedő betegeknél

A.4.1

Sponsor's protocol code number

DS107E-02

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	Dignity Sciences Limited
B.1.3.4	Country	Ireland
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	Dignity Sciences Limited
B.4.2	Country	Ireland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dignity Sciences Limited
B.5.2	Functional name of contact point	David Coughlan
B.5.3	Address:
B.5.3.1	Street Address	Trintech Building, South County Business Park
B.5.3.2	Town/ city	Leopardstown
B.5.3.3	Post code	DUBLIN 18
B.5.3.4	Country	Ireland
B.5.4	Telephone number	+35312933590
B.5.5	Fax number	+35312176117
B.5.6	E-mail	david.coughlan@dignitysciences.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	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	0.1% DGLA Cream
D.3.2	Product code	DS107E
D.3.4	Pharmaceutical form	Cream
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	Not Available
D.3.9.1	CAS number	1783-84-2
D.3.9.2	Current sponsor code	DS107E
D.3.9.3	Other descriptive name	DGLA
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.3.11 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	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	1.0% DGLA Cream
D.3.2	Product code	DS107E
D.3.4	Pharmaceutical form	Cream
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	Not Available
D.3.9.1	CAS number	1783-84-2
D.3.9.2	Current sponsor code	DS107E
D.3.9.3	Other descriptive name	DGLA
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	1.0
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: 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	5.0% DGLA Cream
D.3.2	Product code	DS107E
D.3.4	Pharmaceutical form	Cream
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	Not Available
D.3.9.1	CAS number	1783-84-2
D.3.9.2	Current sponsor code	DS107E
D.3.9.3	Other descriptive name	DGLA
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	5.0
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	Cream
D.8.4	Route of administration of the placebo	Topical use (Noncurrent)

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 compare the effectiveness of three doses of topically applied DGLA cream, versus placebo, in the treatment of adult patients with mild to moderate atopic dermatitis

E.2.2

Secondary objectives of the trial

To assess the safety, tolerability and the bioavailability of three doses of topically applied DGLA cream, versus placebo, in patients with mild to moderate atopic dermatitis

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Clinically confirmed diagnosis of active atopic dermatitis according to Hanifin and Rajka criteria.
2.Patients with mild to moderate atopic dermatitis at screening; Rajka-Langeland score 3-7.5.
3. Patients with mild to moderate atopic dermatitis covering 2-50% of the body surface area
4.Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF).
5.Patients in general good health as confirmed by a physical examination and by medical history.
6.Patients who are able and willing to give signed informed consent (ICF).
7.Patient’s body mass index (BMI) is between 18 and 30 kg/m2 inclusive.
8.Female patients of child bearing potential, and female partners of male patients, must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) for the duration of the study; or agree to sexual abstinence for the duration of the study. Note: women of non-child bearing potential are:
- women who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation)
- women greater than 60 years of age, or
- women greater than 40 and less than 60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (FSH≥40 mlU/mL) or cessation of menses for at least 24 months without FSH levels confirmed.
9.Patients who are able and willing to stop treatment for atopic dermatitis for the washout period (except emollients).

E.4

Principal exclusion criteria

1.Females with positive pregnancy test at screening (Visit 1) or start of treatment/baseline (Visit 2) or lactating women.
2.Patients who have received phototherapy (UVA, UVB) within 4 weeks of screening (Visit 1).
3.Patients with Netherton’s Syndrome.
4.Patients with clinically significant impairment of renal or hepatic function.
5.Patients with other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis, viral, bacterial and fungal skin infections).
6.Patients with a history of hypersensitivity to any substance in the IMP.
7.Patients with severe atopic dermatitis; Rajka-Langeland score 8-9.
8.Patients with a history of clinically relevant ECG abnormalities
9.Patients treated with any experimental drug within 30 days prior to start of treatment/baseline visit (Visit 2).
10.Patients who have used any of the medications and therapeutic regimens excluded from the study within 14 days prior to baseline/day 0 visit (Visit 2).
11.Patients with a significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease.
12.Patients with a medical history of chronic infectious disease (HCV, HBV, HIV).

E.5 End points

E.5.1

Primary end point(s)

Change in modified Eczema Area and Severity Index (mEASI) from baseline (Day 0/start of IMP treatment) to 28 days (end of treatment) to evaluate the efficacy of three doses of topically applied DGLA cream in comparison to placebo

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days

E.5.2

Secondary end point(s)

Change in modified Eczema Area and Severity Index (mEASI) from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14 and 21 days.

Change in Investigator’s Global Assessment (IGA) score from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.

Change in the patient’s VAS pruritus score from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.

Change in the Patient Orientated Eczema Measure (POEM) from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.

Change in the Dermatology Life Quality Index (DLQI) score from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.

E.5.2.1

Timepoint(s) of evaluation of this end point

From screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.

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

Yes

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

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

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

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)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

195

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

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

130

F.4.2

For a multinational trial

F.4.2.1

In the EEA

200

F.4.2.2

In the whole clinical trial

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

2013-01-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-01-09

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