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    Summary
    EudraCT Number:2012-001296-36
    Sponsor's Protocol Code Number:PCTA206/11
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-03-09
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2012-001296-36
    A.3Full title of the trial
    A double blinded, prospective, randomized, vehicle controlled, multi-center study of photodynamic therapy with Visonac cream in patients with acne vulgaris
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study of photodynamic therapy with Visonac cream in patients with acne vulgaris
    A.4.1Sponsor's protocol code numberPCTA206/11
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01347879
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/017/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPhotocure ASA
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSponsor
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPhotocure
    B.5.2Functional name of contact pointClinical Trials information
    B.5.3 Address:
    B.5.3.1Street AddressHoffsveien 4
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeNO-0275
    B.5.3.4CountryNorway
    B.5.4Telephone number4722062210
    B.5.5Fax number4722062218
    B.5.6E-mailinfo@photocure.no
    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 No
    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.3.1Product nameVisonac
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.1CAS number 79416-27-6
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameMETHYL AMINOLEVULINATE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21579
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acne vulgaris
    E.1.1.1Medical condition in easily understood language
    acne
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy and safety of Visonac PDT in patients with severe acne, score 4 on the IGA scale
    E.2.2Secondary objectives of the trial
    Not specified
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female patients, aged 12 to 35 years, Fitzpatrick skin type I through VI, with 25 to 75 inflammatory and 20 to 100 non-inflammatory acne lesions, no more than 3 nodules on the face and a global acne severity score of 4.
    E.4Principal exclusion criteria
    Patients with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) will be excluded. The following washout periods for prior medications apply: 14 days for topical treatment, 1 month for oral antibiotics, and 6 months for oral isotretinoin. Patients using oral contraceptive must have used the same product and dose for at least 3 months and agree to stay with the same product and dose during the study participation. Patients that have had facial procedures like dermabrasion, chemical or laser peels within the last month will be excluded. Patients using testosterone, any other systemic hormonal treatment or hormonal contraceptives solely for control of acne will be excluded. Patients using testosterone, any systemic hormonal treatment for other reasons must have used the same product and dose for at least 3 months.
    Patients with moderate, severe and very severe facial scarring will be excluded
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change from baseline in facial inflammatory lesion count (nodules, papules, and pustules) 12 weeks after the first treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after first treatment
    E.5.2Secondary end point(s)
    Absolute change from baseline in facial non-inflammatory lesion count (open and closed comedones) 12 weeks after the first treatment.
    Percent change from baseline in facial inflammatory (nodules, papules, and pustules) and non-inflammatory (open and closed comedones) lesion counts 12 weeks after the first treatment.
    Proportion of patients with success according to IGA scale based on the facial assessment at 12 weeks after the first treatment. One scale will be used including inflammatory and non-inflammatory lesions. Success is defined as an improvement of at least 2 grades from the baseline score.
    Pain during illumination using a Visual Analogue Scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
    Percent of patients with local (facial and non-facial treatment site) and non-local adverse events.
    Erythema score
    PAP levels
    Scarring at week 12
    Local (facial and non-facial treatment site) and non-local adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    Troughout the study
    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 No
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    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.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 Yes
    F.1.1Number of subjects for this age range: 90
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 90
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 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)
    Normal treatment as expected for the condition
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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