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    Summary
    EudraCT Number:2010-018313-29
    Sponsor's Protocol Code Number:PPA/904A/001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-03-18
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2010-018313-29
    A.3Full title of the trial
    Open-label, within-subject controlled, Phase IIa study to investigate repeat dose antimicrobial photodynamic therapy in patients with acne vulgaris.
    A.3.2Name or abbreviated title of the trial where available
    Acne treatment by photodynamic therapy. Version 1
    A.4.1Sponsor's protocol code numberPPA/904A/001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPhotopharmica
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namePPA904 sterile gel
    D.3.2Product code PPA904
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 30189-85-6
    D.3.9.2Current sponsor codePPA904
    D.3.9.3Other descriptive name3,7-bis(N,N-dibutylamino)phenothiazin-5-ium bromide
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acne vulgaris
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10000519
    E.1.2Term Acne Vulgaris
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if repeat treatments with a new drug and light combination (photodynamic therapy) can cause a reduction in lesion (spot) counts in subjects with acne vulgaris on the upper back.
    E.2.2Secondary objectives of the trial
    To determine if repeat treatments with a new drug and light combination(photodynamic therapy) can cause a reduction in the bacteria count (Propionibacterium acnes) of acne vulgaris on the upper back.

    To determine if repeat treatments with a new drug and light combination(photodynamic therapy)can alter the severity of acne vulgaris.

    To monitor the safety of repeat treatments with a new drug and light combination (photodynamic therapy).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female subjects of any race, aged 16 to 35 years inclusive, with truncal acne vulgaris.

    Subjects will have voluntarily read, signed and dated the approved Informed Consent Form (ICF) prior to any participation in the study.

    Have a minimum of 15 inflammatory lesions (papules and pustules) within each of the allocated treatment areas of 72 sq cm on the back.

    Have a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) within each of the allocated treatment areas of 72 sq cm on the back.

    Subjects will have a Propionibacterium acnes microbiology scrub taken of each pre-identified treatment area to confirm that the total bacterial load of each area is equal to or greater than 10,000 CFU/sq cm, determined within 2 weeks of the first dose.

    Female subjects of childbearing potential must have a negative urine pregnancy test (UPT) at the screening visit prior to first dose if no menstrual cycle within previous 4 weeks and must practice a highly effective method of contraception during the study: oral contraception (must have been on a stable dose for 3 months prior to study entry and for duration of study), IUD, systemic (injectable or patch) contraception, strict abstinence or partner had a vasectomy.
    E.4Principal exclusion criteria
    Subjects under 16 years of age.

    Subjects with acne cystic lesions.

    Female subjects who are pregnant, nursing or planning a pregnancy during the study.

    Subjects with known allergy to one of the components of the gel formulation (methyl cellulose and propylene glycol).

    Subjects who have participated in another investigational drug or device research study within 30 days of enrollment/ baseline.

    Subjects currently on photosensitising medication or a history of photosensitivity disorders or cutaneous photosensitisation.

    Subjects who are known to abuse alcohol or drugs currently, or have psychological disorders that could affect follow up care or treatment outcomes.

    Subjects who have any skin pathology or condition (e.g. eczema) that would interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.

    Subjects who have used OTC (over the counter) acne medicated cleansers or soaps within two weeks of initiation of treatment to the treatment area.

    Subjects with more than 2 nodules in the treatment area (nodule= lesion greater than or equal to 0.5cm in diameter).

    Subjects who plan to be exposed to artificial tanning devices, ultraviolet light or excessive sunlight during the trial.

    Subjects with a wash-out period for topical treatment on the back less than
    • 2 weeks- Corticosteroids, antibiotics, antiseptics, benzoyl peroxide, salicylic acid, other anti-inflammatory drugs, or other acne treatments
    • 4 weeks- Retinoids, including tazarotene, adapalene, tretinoin
    • 8 weeks- Light treatments, microdermabrasion or chemical peels
    • 2 weeks- Zinc containing drugs

    Subjects who have used any of the following systemic anti-acne medications:

    4 weeks- Corticosteroids (including intramuscular and intralesional injections) Inhaled corticosteroids allowed if use is stable (stable use is defined as dose and frequency unchanged for at least 2 weeks prior to the initiation treatment)
    4 weeks- Antibiotics
    4 weeks- Nicotinamide
    4 weeks- Spironolactone
    6 months-Retinoid Therapy


    Subjects with back hair that in the opinion of the investigator could interfere with the study assessments.

    Subjects with acne conglobata, acne fulmicans, secondary acne (chloracne, drug induced etc) or severe nodulocystic acne requiring treatment with oral isotretinoin.
    E.5 End points
    E.5.1Primary end point(s)
    Change in total lesion count (sum of non inflammatory and inflammatory lesions) from baseline to 12 weeks post first dose.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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
    Light only with PPA Lux 680
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    The trial will end 12 weeks after the tenth subject has received their first treatment (last visit by last subject).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    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.1.1.1In 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.1.2Adults (18-64 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    The PDT procedure is still experimental and will not be available to participants after the end of the trial.
    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 Decision2010-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-11-22
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