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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-002642-32
    Sponsor's Protocol Code Number:Protocol No. PR-00908
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-16
    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 number2008-002642-32
    A.3Full title of the trial
    A Placebo Controlled, Single-Blind, Pilot Clinical Evaluation of the Effect of a Novel Antibiotic Preparation on the Cutaneous Microflora and Clinical Signs in Acne Patients.
    A.4.1Sponsor's protocol code numberProtocol No. PR-00908
    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 SponsorWarner Chilcott UK Limited
    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 name2% minocycline suspending gel
    D.3.2Product code WC3018
    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.3.8INN - Proposed INNMinocycline hydrochloride
    D.3.9.1CAS number 13614-98-7
    D.3.9.2Current sponsor codeWC3018
    D.3.9.3Other descriptive name7-dimethyl-6-demethyl-6-deoxytetracycline
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 Yes
    D.3.11.13.1Other medicinal product typeMinocycline hydrochloride is a member of the tetracycline family of antibiotics
    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 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 name0.5% minocycline WC3018 gel
    D.3.2Product code WC3018
    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.3.8INN - Proposed INNMinocycline hydrochloride
    D.3.9.1CAS number 13614-98-7
    D.3.9.3Other descriptive name7-dimethylamino-6-demethyl-6-deoxytetracycline
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 Yes
    D.3.11.13.1Other medicinal product typeMinocycline hydrochloride is a member of the tetracycline family of antibiotics
    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 placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    WC3018 will be indicated for the treatment of of mild to moderate acne vulgaris.
    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
    The purpose of this study is to evaluate the efficacy of a new topical formulation of minocycline (two concentration to be tested) compared with placebo in the treatment of mild to moderate acne vulgaris, with particular reference to effects on the cutaneous microflora.

    To determine the proportion of subjects in each treatment group with a reduction in cutaneous Propionibacterium spp. of 1.0 log10 colony forming units per cm2 at 4, 8 and 12 weeks compared to baseline.

    Reduction in Propionibacterium spp. (g10 colony forming units per cm2) at 4, 8 and 12 weeks compared to baseline.
    E.2.2Secondary objectives of the trial
    •Proportion of subjects in each treatment group with a reduction in cutaneous Micrococcaceae spp. of 1.0 log10 colony forming units per cm2 at 4, 8 and 12 weeks compared to baseline.
    •Reduction in cutaneous Micrococcaceae spp. (log10 colony forming units per cm2) at 4, 8 and 12 weeks compared to baseline
    •To determine the change in non-inflammatory and inflammatory lesion counts at 4, 8 and 12 weeks compared to baseline.
    •To determine the change in skin condition by clinical assessment of acne (according to the “Leeds Revised Acne Grading System”) at 4, 8 and 12 weeks compared to baseline.
    •To determine subject-perceived change in skin condition by completion of an Acne Quality of Life Questionnaire (QOL) at 4, 8 and 12 weeks compared to baseline.
    •To record change in skin condition by use of photography at 12 weeks compared to baseline
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Has given written informed consent
    2.Is between 12 and 45 years of age
    3.Has a diagnosis of mild to moderate facial acne vulgaris (grade ≤ 4.0)
    4.Females of childbearing potential must have a negative urine pregnancy test and if sexually active or become sexually active during the study, must agree to use an effective form of birth control (as directed by the Clinical Investigator) for the duration of the study.
    5.Is willing to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure and tanning booths for duration of the study.
    E.4Principal exclusion criteria
    1.Females who are pregnant or lactating, or pre-menopausal women who are sexually active and not using a reliable method of contraception.
    2.Males who are sexually active and not using a reliable method of contraception.
    3.Is planning a pregnancy during the study.
    4.Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
    5.Is using antibiotic-based acne therapy (systemic or topical) at baseline or in the 4 weeks preceding baseline.
    6.Is unwilling to abstain from use of antibiotic-based acne therapy (systemic or topical) for the duration of the study.
    7.Is using OTC topical acne treatment at baseline or in the 4 weeks preceding baseline.
    8.Is unwilling to abstain from use of OTC topical acne treatment for the duration of the study.
    9.Is using any of the following at baseline or in the 4 weeks preceding baseline:
    ­ Anti-inflammatory drugs (systemic or topical)
    ­ Topical steroids
    ­ Corticoids
    10.Is using retinoids, immunosuppressive drugs, anti-cancer drugs at baseline or in the 6 months prior to baseline.
    11.Is taking daily anti-histamines on a long term basis.
    12.Has changed hormonal treatment at baseline or in the 4 weeks preceding baseline (i.e. started, stopped or changed contraceptives).
    13.Is taking a medication which, in the opinion of the investigator, could compromise the safety of the subject or affect the outcome of the study (for example, interfere with skin assessments).
    14.Has received immunisation during the study or in the 10 days prior to screening.
    15.Has any cutaneous pathology on the face (e.g. psoriasis, eczema, vitiligo, pytiriasis versicolor or other skin disorders), irritated skin, freckles, beauty spots or a tattoo which, in the opinion of the investigator, could compromise the safety of the subject or affect the outcome of the study (for example, interfere with skin assessments).
    16.Has any significant concurrent illness including diabetes.
    17.Has significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study.
    18.Has been treated for any type of cancer within the last six months.
    19.Has had a fever in the 12 hours prior to the baseline visit.
    20.Has exposure to excessive sunlight or to UV rays by UV tanning equipment at baseline or in the 4 weeks preceding baseline.
    21.Used self tanning lotion, bleach, wax or hair removal treatments on the face at baseline or in the 4 weeks preceding baseline.
    22.Has been previously randomised into this study
    23.Is participating in a pharmacological study, systemic drug study and/or any study using the face as a test site at baseline or in the 4 weeks preceding baseline.
    24.Is unable, in the opinion of the Investigator, to comply fully with the study requirements.
    25.Is an employee of 4-Front Research or Warner Chilcott or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of an employee.
    E.5 End points
    E.5.1Primary end point(s)
    •The change from baseline in proportions of subjects in each treatment group with a reduction in cutaneous Propionibacterium spp. of 1.0 log10 colony forming units per cm2 at 4, 8 and 12 weeks will be analysed by Chi-square and/or Fisher Exact tests.
    •The change from baseline in cutaneous Propionibacterium spp. (log10 colony forming units per cm2) in each treatment group will be analysed by Analysis of Variance (ANOVA) with change in cutaneous Propionibacterium as outcome variable and product as factor, at 4, 8 and 12 weeks. Alternatively, non-parametric tests such as the Kruskall Wallis test may be utilised.
    •AUC above baseline will be computed to determine change from baseline in cutaneous Propionibacterium spp. of 1.0 log10 colony forming units per cm2 in each treatment group across time, thereby increasing the analysis sensitivity. Analysis of Variance (ANOVA) with AUC above baseline as outcome variable and product as factor will be employed.
    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 No
    E.6.4Safety No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    placebo controlled
    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.8.3 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.8.5.1Number of sites anticipated in the EEA0
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 90
    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 Decision2008-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-04
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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