Clinical Trials Register

Summary
EudraCT Number:	2012-004965-41
Sponsor's Protocol Code Number:	DS107E-03
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-12-27
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

Germany - BfArM

A.2

EudraCT number

2012-004965-41

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 Acne Vulgaris

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 Acne Vulgaris

A.3.2

Name or abbreviated title of the trial where available

Safety and Efficacy Study of DGLA Cream in Patients with Acne Vulgaris

A.4.1

Sponsor's protocol code number

DS107E-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	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	Laura Hopkins
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.5.6	E-mail	Laura.Hopkins@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	DS107E DGLA Cream
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	proposed DIGAMOLENIC ACID and DIGAMOLENATE
D.3.9.1	CAS number	1783-84-2
D.3.9.2	Current sponsor code	DS107E-03
D.3.9.3	Other descriptive name	DIHOMO-GAMMA-LINOLENIC ACID (DGLA)
D.3.9.4	EV Substance Code	SUB77517
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
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	DS107E DGLA Cream
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	proposed DIGAMOLENIC ACID and DIGAMOLENATE
D.3.9.1	CAS number	1783-84-2
D.3.9.2	Current sponsor code	DS107E
D.3.9.3	Other descriptive name	DIHOMO-GAMMA-LINOLENIC ACID (DGLA)
D.3.9.4	EV Substance Code	SUB77517
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
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

Patients with mild to moderate facial papulopustular acne (acne comedonica or acne papulopustulosa) will be enrolled in the study.

E.1.1.1

Medical condition in easily understood language

Mild to Moderate Acne Vulgaris

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	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10000519
E.1.2	Term	Acne vulgaris
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

Primary Objective:
To compare the efficacy of different concentrations of the study treatment DGLA cream on facial papulopustular acne in comparison to a placebo control.

E.2.2

Secondary objectives of the trial

Secondary Objectives:
To assess the safety and tolerability of topically applied DS107E DGLA Cream in different concentrations.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Clinically confirmed diagnosis of facial acne papulopustulosa or acne papulopustulosa et comedonica with a mild to moderate intensity (grade 2 to 8 according to the revised Leeds Scale of Acne Grading) and with at least 12 inflammatory lesions excluding the nose
2. General good health as confirmed by a physical examination and by medical history
3. Acceptance to abstain from any other systemic or topical acne treatment during trial
4. Acceptance to abstain from prolonged UV exposure via intensive sunbathing, the use of tanning equipment or outdoor pursuits such as mountain sports activities
5. Male or female patients aged 16 to 40 years on the day of signing the informed consent form (ICF).
6. Patients who are able and willing to give signed informed consent (ICF).
7. Body mass index (BMI) of between 18 and 30 kg/m2 inclusive.
8. Patients taking oral contraceptives containing compounds with known effects on acne are allowed providing that the subject has been on stable dose for 6 months prior to enrollment.

E.4

Principal exclusion criteria

1. Females with a positive pregnancy test at baseline
2. Females of childbearing potential and female partners of male patients who have not used for 6 months prior to the trial and are not willing to use for the duration of the trial; a safe contraceptive measure (e.g. IUD or oral contraceptives, diaphragm or condom if used in combination with a spermicide)
3. Diagnosis of any acneiform diseases like exogenous acne, drug induced acne, cosmetic induced acne
4. Presence of more than 2 nodules on the face. Up to two nodules are allowed.
5. Localisation of acne that requires treatment predominantly on the chest and/or the back
6. Patients with any clinically significant abnormal laboratory results at screening (biochemistry, haematology, urinalysis).
7. Other skin conditions that might interfere with acne diagnosis and/or evaluation (such as facial psoriasis, seborrheic dermatitis, perioral dermatitis and papulo-pustular rosacea)
8. Treatment with any of the following medications within a timeframe prior to screening assessment of:
-Corticosteroids, antibiotics (except plain penicillins) 4 weeks
-Other systemic acne treatments (including isotretinoin) 6 months
-Spironolactone 3 months.
9. Patients taking oral contraceptives containing compounds with known effects on acne; these include norethisterone/norethindrone, drospirenone, ciproterone acetate and norgestimate and other oral contraceptives who are not on stable dose for 6 months prior to enrollment.
10. Patients taking hormonal contraception solely for the control of acne
11. Treatment with any other topical acne drug within the last 14 days prior to the screening assessment
12. Presence of a significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease
13. Recent history of alcohol or any other substance abuse
14. Treatment with any experimental drug within 30 days prior to the screening assessment
15. Inability to comply with the study protocol
16. Patients who have received phototherapy (UVA, UVB) within 4 weeks of screening (Visit 1).
17. Patients with clinically significant impairment of renal or hepatic function.
18. Patients with a history of hypersensitivity to any substance in the IMP.
19. Patients with severe acne vulgaris or nodulocystic acne
20. Patients with a history of clinically relevant ECG abnormalities.
21. Patients with a known medical history of chronic infectious disease (HCV, HBV, HIV).
22. Patients who are investigational site staff members or relatives of those site staff members or patients who are relatives of Dignity Sciences employees directly involved in the conduct of the trial.

E.5 End points

E.5.1

Primary end point(s)

Efficacy:
1. Change in Investigators Global Assessment (IGA) of acne severity from baseline to the end of week 12
2. Change of total count of acne lesions from baseline to the end of week 12

E.5.1.1

Timepoint(s) of evaluation of this end point

Efficacy:
- Change in Investigators Global Assessment (IGA) of acne severity from baseline to the end of week 12
- Change of total count of acne lesions from baseline to the end of week 12

E.5.2

Secondary end point(s)

Efficacy:
a) Change in Investigators Global Assessment (IGA) of acne severity after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment).

b) Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (all acne lesions, count of comedones, papules and pustules and total count of inflammatory lesions)

c) Time to reduction of acne lesions by > 30%

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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

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

The end of the trial is defined as the date when the data for the final analysis are locked.

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

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:

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

126

F.1.3

Elderly (>=65 years)

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

adolescents 16-17years old

F.4 Planned number of subjects to be included

F.4.1

In the member state

150

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

2013-03-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-01-16

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