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    Summary
    EudraCT Number:2009-009956-20
    Sponsor's Protocol Code Number:ICG-REG_01
    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:2009-03-17
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2009-009956-20
    A.3Full title of the trial
    Prospective, randomized, controlled, mono-centric, two-armed, single-blinded pilot study for the treatment of venous and capillary vascular malformations by Indocyanine Green-augmented laser therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the efficacy of laser treatment using a dye as an enhancer
    Studie zur Effektivitaet von Lasertherapie durch Anwendung eines Farbstoffes als Verstärker
    A.3.2Name or abbreviated title of the trial where available
    ICG-augmented laser therapy
    A.4.1Sponsor's protocol code numberICG-REG_01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFree State of Bavaria rep. by the Univ. of Regensburg, rep. by the Regensburg Univ. Hospital
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Hospital of Regensburg
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Regensburg
    B.5.2Functional name of contact pointPhilipp Babilas, MD
    B.5.3 Address:
    B.5.3.1Street AddressFranz-Josef-Strauss-Allee 11
    B.5.3.2Town/ cityRegensburg
    B.5.3.3Post code93053
    B.5.3.4CountryGermany
    B.5.4Telephone number+499419449605
    B.5.5Fax number+499419449532
    B.5.6E-mailPhilipp.Babilas@ukr.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ICG Pulsion(R)
    D.2.1.1.2Name of the Marketing Authorisation holderPulsion Medical Systems AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINDOCYANINE GREEN
    D.3.9.1CAS number 3599324
    D.3.9.3Other descriptive nameINDOCYANINE GREEN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Aqua ad iniectabilia Braun
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAqua ad iniectabilia
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive nameWATER FOR INJECTION
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    venous and capillary vascular malformations
    E.1.1.1Medical condition in easily understood language
    Red spots due to vascular dysfunction at face or leg
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10047091
    E.1.2Term Vascular malformations and acquired anomalies
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this pilot study is to evaluate the feasibility of a future main study, which will evaluate the efficacy of ICG-mediated laser for the treatment of cutaneous venous and capillary vascular malformations
    E.2.2Secondary objectives of the trial
    Comparison of safety of and tolerability to study treatments.
    Cosmetic outcome 12 weeks after study treatments.
    Evaluation of parameters for a main trial.
    Possibility to recruit patients.
    Randomization and blinding.
    Calculation of patient number.
    Practicability and identification of problems of the design of the main study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent signed before or at Screening Visit by the patient (only adults).
    - Caucasian patients of both sexes.
    - Diagnosis of cutaneous venous and capillary vascular malformations at all sites of the skin except the hairy scalp.
    - Distance between study lesion borders is ≥ 0.5 cm.
    - Skin sun sensitivity type I to IV according to Fitzpatrick.
    E.4Principal exclusion criteria
    - Pre-treatment of cutaneous venous and capillary vascular malformations eligible for study procedures during the 12 weeks preceding study treatment (e.g. cryotherapy, radiotherapy, laser treatment).
    - Treatment with systemic retinoids during the 3 months preceding study therapy.
    - Female patients with a positive pregnancy test.
    - Breast-feeding female patients.
    - Patients with clinically relevant suppression of the immune system.
    - Patients with non-controllable thyroid malfunction, for which administration of iodine is contraindicated.
    - Patients with an allergy against iodine.
    - Patients with severe liver malfunction.
    - Skin diseases that might interfere with response evaluation of study treatment.
    - Skin sun sensitivity type V or VI according to Fitzpatrick.
    - Proven sensitivity or adverse reactions to one or more of the ingredients of ICG.
    - Dementia or psychic conditions that might interfere with the ability to understand the study and thus give a written informed consent.
    - Planned extensive UV-exposure (UV-phototherapy, vacation, tanning studio) in the first 2 months after treatment.
    - Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion.
    - Suspected lack of compliance.
    - Uncooperative patients.
    E.5 End points
    E.5.1Primary end point(s)
    clinical improvement 3 months following ICG-augmented laser therapy
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months following treatment
    E.5.2Secondary end point(s)
    efficacy, side effects, patient satisfaction
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months after treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard laser treatment
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    irreversible damage to the skin by this procedure
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    no specific treatment necessary
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-29
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