Clinical Trials Register

Summary
EudraCT Number:	2015-002699-26
Sponsor's Protocol Code Number:	PREFECT
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2015-08-13
Trial 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

2015-002699-26

A.3

Full title of the trial

Pilot study of tolerability and effectivity following application of two combination topical acne products clindamycin 1% and 0.025% tretinoin gel (Acnatac® Gel), adapalen 0,1% and benzoyl peroxide 2,5% gel (Epiduo® Gel).

Pilotstudie zur Bestimmung der Verträglichkeit und Effektivität von Clindamycin 1% und 0,025% Tretinoin Gel (Acnatac® Gel) und Adapalen 0,1% und Benzoylperoxid 2,5% Gel (Epiduo® Gel) in der Behandlung der Akne vulgaris

A.3.1

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

Study to compare two gels that are used to treat acne vulgaris. It will be compared the tolerability and effectivity following application of two combination topical acne products clindamycin 1% and 0.025% tretinoin gel (Acnatac® Gel), adapalen 0,1% and benzoyl peroxide 2,5% gel (Epiduo® Gel).

Studie zur Überprüfung, welches Gel zur Behandlung der Akne besser wirkt und verträglich ist. Verglichen werden Acnatac® Gel und Epiduo® Gel miteinander

A.3.2

Name or abbreviated title of the trial where available

PREFECT

A.4.1

Sponsor's protocol code number

PREFECT

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GWT-TUD GmbH
B.1.3.4	Country	Germany
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	Klinik und Poliklinik für Dermatologie, Universitätsklinikum Carl Gustav Carus an der TU Dresden
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Klinik und Poliklinik für Dermatologie, Universitätsklinikum Carl Gustav Carus an der TU Dresden
B.5.2	Functional name of contact point	PI Roland Aschoff
B.5.3	Address:
B.5.3.1	Street Address	Fetscherstraße 74
B.5.3.2	Town/ city	Dresden
B.5.3.4	Country	Germany
B.5.4	Telephone number	00493514583159
B.5.5	Fax number	00493514585739
B.5.6	E-mail	roland.aschoff@uniklinikum-dresden.de

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	Acnatac® Gel
D.2.1.1.2	Name of the Marketing Authorisation holder	MEDA Pharma GmbH & Co.KG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Acnatac® Gel
D.3.2	Product code	85210.00.00
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)
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	Comparator
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.2.1.1.1	Trade name	Epiduo® Gel
D.2.1.1.2	Name of the Marketing Authorisation holder	Galderma Laboratorium GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Epiduo® Gel
D.3.2	Product code	67913.00.00
D.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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)	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

acne vulgaris

Akne vulgaris

E.1.1.1

Medical condition in easily understood language

Acne vulgaris

Akne vulgaris

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

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 tolerability of the two acne products. The main variable ist the transepidermal water loss (TEWL)

Vergleich der Verträglichkeit auf der Haut der beiden Akneprodukte. Hauptzielvariable ist der transepidermale Wasserverlust (TEWL)

E.2.2

Secondary objectives of the trial

- Measuring the severity of burning/ stinging and itching using Study Subject Self-Assessment
-Measuring and recording the number of acneiform lesions
-Measuring health-related quality of life using DLQI-Score/CDLQI
-Measuring skin hydration using Corneometer
-Measuring transepidermal water loss (TEWL) using Tewameter
-Measuring skin surface pH using pH-Meter
-Measuring skin sebum excretion using Sebumeter

- Einzel- und Summenscore des Investigators´ Global Assessment
- Einzel- und Summenscore des Study Subject Self-Assessment
- Anzahl der Akneläsionen
- CDLQI/DLQI
- Score des CPSQ
- Hautfeuchtigkeit
- Hautoberflächen-pH-Wert
- Hautfettgehalt

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Diagnosis of mild to moderate facial acne vulgaris at baseline - Age: 14 years to 50 years
- No evidence of facial irritation (erythema, dryness/scaling,
burning/itching/stinging) that is not typical for acne vulgaris
-Willingness to take part in acne study including screening visit and follow up visits on day 0,7, and 21
-No use of systemic antibiotics, steroids, retinoids and keratolytics within the last 30 days before start of the acne study
-Patients have to sign personally consent form and follow study procedures
-Patient is in good general health

- diagnostizierte leichte bis mittelschwere Akne vulgaris zu Stu-dienbeginn (20-150 Akneläsionen im Gesicht, davon 10-100 nich t-inflammatorische und/oder 10-50 inflammatorische Läsionen und nicht mehr als 2 Zysten oder Knoten)
- Hauttyp I bis III nach Fitzpatrick
- Alter: 14 Jahre bis 50 Jahre,
- keine Anzeichen von Hautirritationen im Gesichtsbereich (Rö-tungen, Hauttrockenheit, Brennen, Stechen, Juckreiz, welche nicht im Rahmen der Akne vorkommen),
- Bereitschaft zur Studienteilnahme inklusive Screeningsitzung und Folgeuntersuchungen an Tagen 0, 7 und 21
- schriftliche Einwilligung des Patienten und bei Minderjährigen auch der Eltern zur Studienteilnahme
- Patient bei allgemeiner guter körperlicher und geistiger Gesund-heit

E.4

Principal exclusion criteria

Female patients who were pregnant, planning to become pregnant or breastfeeding
-Sexually active female subjects do not use a medically acceptable form of contraception (oral contraception, injectable or implantable methods or intrauterine devices)
- Female patients who are in childbreaking years except
post-menopausal (12 Monate natürliche Amenorrhoe),
▪ postoperative (6 weeks after ovariectomy with or without hysterectomy)
-regulary and correct use of contraceptive with error rate < 1 %/year
-no sex
- vasectomy of the partner

- Diseases of the facial skin other than acne
-No concomitant topical medications (including make-up) or keratolytics as sulphur, salicylic acid, benzoyl peroxide, resorcin and abradents and acid-containing peels one week before the study starts
-Patients who had facial procedures (chemical peel, laser therapy, photodynamic therapy, microdermabrasion, or UV light therapy) within the past 4 weeks
-No concomitant participation in other studies within the past 30 days
-Hypersensitivity against any ingredients of Acnatac® -gel or Epiduo®gel
-Systemic medication with antibiotics or antibiotics within the last 4 weeks before study start
- Systemic medication with retinoids within the last 6 months before study start
-Topical treatment of acne vulgaris within the last two weeks before study
-Acne fulminans,
-Severe systemic disease respectively taking immunosuppressive drugs
-Severe liver disease
-Severe renal disease
-
-History or presence of regional enteritis or inflammatory bowel disease
-Other reasons that the doctor in charge decides about

- Schwangerschaft oder Stillzeit,
- Fehlende oder unsichere Kontrazeption für Patientinnen im ge-bärfähigen Alter,
- Frauen im gebärfähigen Alter, außer Frauen, die die folgenden Kriterien erfüllen:
▪ post-menopausal (12 Monate natürliche Amenorrhoe),
▪ postoperativ (6 Wochen nach beidseitiger Ovarektomie mit oder ohne Hysterektomie),
▪ regelmäßige und korrekte Anwendung einer Verhü-tungsmethode mit Fehlerquote < 1 % pro Jahr (z.B. Im-plantate, Depotspritzen, orale Kontrazeptiva, Intrauterine Device – IUD),
▪ sexuelle Enthaltsamkeit,
▪ Vasektomie des Partners.
- genetischer Defekt der epidermalen Barriere (z. B. Netherton-Syndrom),
- keine gleichzeitige Behandlung mit topischen Präparaten (inklu-sive Kosmetika) oder keratolytischen Substanzen wie Schwefel, Salicylsäure, Benzoylperoxid, Resorcin und chemische Abrasi-va, Seifen mit Peelingwirkung und stark austrocknenden Effek-ten, Duftstoffe, Zitrusextrakte, topischen Antibiotika, Korti-kosteroide, Retinoide oder Azelainsäure bis zwei Wochen vor Studienbeginn und/oder während der Studie außer der Studien-medikation.
- Intensive natürliche oder künstliche UV-Lichttherapie (z.B. UVB, UVA, PUVA) innerhalb der letzten 4 Wochen vor Be-ginn der Studie und/oder während der Studie,
- Gleichzeitige Teilnahme an anderen Studien,
- Teilnahme an anderen klinischen Studien innerhalb der letzten 30 Tage vor Beginn der Studie,
- Überempfindlichkeit gegen einen Bestandteil von Acnatac® -Gel oder Epiduo®Gel,
- Erkrankungen, die einer Anwendung mit Acnatac® -Gel und Epiduo®Gel entgegenstehen,
- Einnahme von Antibiotika oder Glukokortikosteroiden inner-halb der letzten 4 Wochen vor Beginn der Studie,
- Einnahmen von Retinoiden innerhalb der letzten 6 Monate vor Beginn der Studie,
- Topische Therapie der Akne innerhalb der letzten 2 Wochen vor Beginn der Studie,
- Akne fulminans,
- Schwere systemische Erkrankungen bzw. Anwendung von Im-munsuppressiva,
- schwere Nieren – oder Lebererkrankungen,
- regionale Enteritis, Colitis ulcerosa oder bekannte antibiotikaas-soziierte Kolitis,
- Mangelnde oder zweifelhafte Kooperationsfähigkeit oder Ko-operationsbereitschaft,
- Anderweitige Gründe, welche gemäß Prüfer eine Teilnahme an der Studie ausschließen

E.5 End points

E.5.1

Primary end point(s)

Difference of the TEWL at the beginn of the study and after 3 weeks of product application.

Differenz des TEWL vor Beginn der Studie und nach 3-wöchiger Anwendung der Akneprodukte.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 weeks

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

3 weeks

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

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

E.8.1.3

Single blind

Yes

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)

Yes

E.8.2.2

Placebo

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.8.5

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

Da es sich um Patienten mit Akne handelt kommt den Patienten nach Abschluss der Untersuchung bei Zustimmung eine weiterführende adäquate Aknetherapie zuteil.

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.1.1.1

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.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

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

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

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)

After the study the patient will be offert a further treatment of the acne vulgaris.

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

2015-08-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-08

P. End of Trial
P.	End of Trial Status	Ongoing

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