Clinical Trials Register

Summary
EudraCT Number:	2012-000263-24
Sponsor's Protocol Code Number:	IPOT2_01.05.2011
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-05-29
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

Austria - BASG

A.2

EudraCT number

2012-000263-24

A.3

Full title of the trial

Comparative study for efficacy and tolerability of topical imiquimod 5% cream therapy versus photodynamic therapy (ALA-PDT) of actinic keratoses on the hands and forearms in organ transplant recipients

Vergleichsstudie über die Wirksamkeit und Verträglichkeit von Imiquimod 5% vs photodynamischer Therapie (ALA-PDT) bei aktinische Keratosen an den Händen und/oder Unterarmen organtransplantierter Patienten

A.3.1

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

Imiquimod versus PDT for actinic keratoses in in organ transplant recipients

Imiquimod versus PDT für aktinische Keratosen organtransplantierter Patienten

A.3.2

Name or abbreviated title of the trial where available

Imiquimod versus PDT für AK bei OTP

A.4.1

Sponsor's protocol code number

IPOT2_01.05.2011

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	Medizinische Universität Wien, Univ. Klinik f. Dermatologie
B.1.3.4	Country	Austria
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	Medizinische Universität Wien, Univ. Klinik f. Dermatologie
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Medizinische Universität Wien, Univ. Klinik f. Dermatologie
B.5.2	Functional name of contact point	Univ. Klinik f. Dermatologie
B.5.3	Address:
B.5.3.1	Street Address	Waeringer Guertel 18-20
B.5.3.2	Town/ city	Wien
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	+431404007700
B.5.5	Fax number	+431404007574
B.5.6	E-mail	gregor.holzer@meduniwien.ac.at

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	ALACARE
D.2.1.1.2	Name of the Marketing Authorisation holder	Photonamic, Wedel, Deutschland
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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-Amonolevulinic acid
D.3.2	Product code	5-ALA
D.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	5-Aminolevulinic acid
D.3.9.1	CAS number	106-60-5
D.3.9.4	EV Substance Code	SUB22645
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	Yes
D.2.1.1.1	Trade name	Aldara
D.2.1.1.2	Name of the Marketing Authorisation holder	Meda AB
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	imiquimod
D.3.9.1	CAS number	99011-02-6
D.3.9.2	Current sponsor code	IMI-6941
D.3.9.3	Other descriptive name	aldara
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
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.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

actinic keratoses

aktinische keratosen

E.1.1.1

Medical condition in easily understood language

superficial skin cancer

oberflächlicher Hautkrebs

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10000614
E.1.2	Term	Actinic keratosis
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

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 efficacy of topical imiquimod 5% cream versus photodynamic therapy with 20% 5-aminolevulinic acid cream in the treatment of actinic keratoses in organ transplant recipients on the ahnds and forearms

Vergleich der Wirksamkeit der topischer Imiqumod 5% Crème Therapie und der 5-ALA 20% PDT in der Behandlung anhand der kompletten klinischen response rate nach Therapieende.

E.2.2

Secondary objectives of the trial

To compare the tolerability, the patients' satisfaction, cosmetic result and the clinical response rate after treatment with topical imiquimod 5% cream versus photodynamic therapy with 20% 5-aminolevulinic acid cream of actinic keratoses in organ transplant recipients

Anzahl und Größe (im Vergleich zur baseline) der AK im behandelten Hautareal 12 und 24 Wochen nach Therapiebeginn, Vergleich der Verträglichkeit beider Therapien anhand visualer Analogschmerzskala, Nebenwirkungsprofil, globale Patientenzufriedenheit und Beurteilung des kosmetischen Ergebnises durch den Arzt

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age 18 years or older
Patients who had received a kidney, liver, lung or heart transplant more than 3 years prior to inclusion into the study
Patients who had been treated at least 6 month prior to study entry with a stable twofold or threefold immunsupressive treatment
Patients who have clinically confirmed epithelial dysplasia (actinic keratoses), equally distributed in contralateral areas on the hands or forearms

E.4

Principal exclusion criteria

Invasive squamous cell carcinoma or basal cell carcinoma in the treatment area
Known allergy to imiquimod and aminolevulinic acid
Patients who have received retinoids, interferons or investigational drugs within 4 weeks of study initiation
Patients who are participating in other dermatological study
Patients with instable organ function
Persistent Hepatitis B or C infections
Any evidence of systemic cancer
Patients who have received any systemic cancer chemotherapy or radiation therapy
Pregnant and lactating women
Patients with other dermatological diseases (psoriasis, eczema) who might confound clinical outcome
Pateitns unable to sticjk with the study protocol
Severe compromised general state

E.5 End points

E.5.1

Primary end point(s)

Clinical complete remission rate of actinic keratoses as calculated by clearance numbers of actinic keratoses in organ transplant recipients 4, 12, and 24 weeks after completion of treatment with imiquimod 5% cream and photodynamic therapy with 20% 5-aminolevulinic acid cream compared to baseline,

Vergleich der Wirksamkeit der topischer Imiqumod 5% Crème Therapie und der 5-ALA 20% PDT in der Behandlung anhand der kompletten klinischen Response (Abeilungsrate) nach Therapieende

E.5.1.1

Timepoint(s) of evaluation of this end point

4, 12, and 24 weeks after completion of treatment with imiquimod 5% cream and photodynamic therapy with 20% 5-aminolevulinic acid cream

4, 12, 24 Wochen nach Therapieende

E.5.2

Secondary end point(s)

Number and size of actinic keratoses 12 and 24 weeks after end of treatment, treatment-associated pain

E.5.2.1

Timepoint(s) of evaluation of this end point

Number and size of actinic keratoses 12 and 24 weeks after end of treatment,
treatment-associated pain: during treatment controls and 4 weeks after treatment
cosmetic response, Global patients' satisfaction: 4,12, 24 weeks after treatment
side effects during all controls

Anzahl und Größe (im Vergleich zur baseline) der AK im behandelten Hautareal 12 und 24 Wochen nach Therapiebeginn,
Vergleich der Verträglichkeit beider Therapien anhand visualer Analogschmerzskala während der Therapie und 4 Wochen nach Therapieende
globale Patientenzufriedenheit und Beurteilung des kosmetischen Ergebnises durch den Arzt nach 4,12, 24 Wochen nach Behandlung
Nebenwirkungsprofil bei jedem Besuch

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

intraindividual

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.8.4.1

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

Yes

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

End of the trial after completion of the follow-up examination 6 months post therapy of 30 participants

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

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)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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

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)

Further medical care of the patients in the clinic of transplant recipients in the division of Immundermatology and Infectious skin diseases

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-06-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-06-07

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2015-01-15

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