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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   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:2005-004448-30
    Sponsor's Protocol Code Number:BT0700-204-GER
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-12-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-004448-30
    A.3Full title of the trial
    A double-blind, placebo-controlled, randomized, multicenter, parallel-group phase IIa trial to assess the efficacy, safety and tolerability of topical 0.35% R115866 gel applied during 12 consecutive weeks in subjects with mild to moderate facial acne vulgaris
    A.3.2Name or abbreviated title of the trial where available
    Efficacy, safety and tolerability of 0.35% R115866 gel in mild to moderate acne
    A.4.1Sponsor's protocol code numberBT0700-204-GER
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 SponsorBarrier Therapeutics nv
    B.1.3.4CountryBelgium
    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 Information not present in EudraCT
    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 nameRambazole
    D.3.2Product code R115866
    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 INNNA
    D.3.9.1CAS number 2014-66-4
    D.3.9.2Current sponsor codeR115866
    D.3.9.3Other descriptive nameRambazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    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
    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 primary objective of this study is the investigation of the effect on the total facial acne lesion count in subjects treated with topical R115866 gel compared to the vehicle-treated group.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to investigate the effects of topical R115866 gel compared to vehicle on
    • Global acne score
    • Global evaluation of effectiveness
    • Total, inflammatory and non-inflammatory lesion count
    • Safety, tolerability and local tolerance
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    A subject meeting all the following inclusion criteria is eligible for inclusion in the trial:
    1. Subjects with a history of facial acne vulgaris of at least 6 months, the presence of mild to moderate facial acne vulgaris having at least 50 non-inflammatory lesions, at least 15 inflammatory lesions with no nodulocystic lesions and with a total number of lesions between 65 and 200
    2. Global Acne Score at Visit 1 must be ≥2 (grading score 0 – 5)
    3. Clinical laboratory Visit 1 test results (biochemistry and hematology, and urine analysis) within the laboratory reference range or considered as not clinically relevant by the investigator
    4. Men and women (age 18 to 50)
    5. Body Mass Index between 18 and 28
    6. Written informed consent to participate in the trial, prior to beginning protocol-specific procedures, indicating an understanding of the purpose of this trial and a willingness to adhere to the treatment regimen and trial procedures described in this protocol
    7. Willingness to continue the usual habits of own cleansing and cosmetic products (e.g. soaps, creams, moisturizers) in the treatment area throughout the course of the trial
    8. If the subject is a female of childbearing potential, she must have a negative urine pregnancy test, and agree to use a highly effective method of contraception during the clinical trial and until the first menses after a 30 days period following the last dose of trial medication. She must be on a stable regimen, for at least three months, of oral contraceptives, contraceptive implant or depot injection or contraceptive patch and willing to continue this contraception combined with an additional local contraception method (IUD, diaphragm or condom and spermicidal agent or sterilization of the partner) starting at screening visit until the first menses after a 30 days period following the last administration of trial medication.
    E.4Principal exclusion criteria
    Subjects meeting one of the following exclusion criteria in not eligible for inclusion in the trial:
    1. Subjects with types of acne other than acne vulgaris or with severe acne requiring oral treatment. Subjects with moderate to severe acne on the trunk
    2. Pregnancy or lactation
    3. Physical condition (e.g. beard) which, in the investigator's opinion, might impair evaluation of acne
    4. Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV or Hepatitis B/Hepatitis C positive)
    5. History of heart-failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
    6. History of any malignancy in the past 5 years, except for adequately treated basal cell carcinoma of the skin
    7. Clinically significant ECG-intervals or morphology of the ECG; QT, or QTc >470 ms in females or >450 ms in males
    8. Subject has used any of the following: oral tretinoin/isotretinoin within the last 12 months before baseline, any other oral anti-acne medication or any oral antibiotics within the last 28 days before baseline; over-the-counter topical acne preparations in the face within the last 14 days before baseline. Topical treatment with 5 % benzoylperoxide within at least 4 weeks
    9. Topical therapy of the face in the last two weeks that may interfere with the aim of the trial, e.g. corticosteroids
    10. Any systemic treatment or the intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants) within 28 days before start of the trial. This does not include minor pain relief medicine, like aspirin or acetaminophene if not more than 500 mg per day are used.
    11. Use of vitamin A (>1000 μg/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotic, anti-depressants, lithium, cyclosporine A
    12. Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1 Subjects with a history of or active alcohol or substance abuse problems
    13. Known hypersensitivity to ingredients of the trial medication (R115866, carbomer, ethanol, polyethylene glycol)
    14. Participation in a clinical trial within the last 30 days prior to the start of this trial
    15. Subjects underlying any other restrictions due to the participation in other tests / test institutes
    16. Employees of the trial site or of the Sponsor company
    17. If in the opinion of the investigator the subject should not participate in the trial for any reason
    E.5 End points
    E.5.1Primary end point(s)
    The difference in the total lesion count after 12 weeks of treatment compared to the lesion count at baseline in the R115866-treated group and the vehicle-treated group
    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 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 Information not present in EudraCT
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    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 Information not present in EudraCT
    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
    see protocol
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-21. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    Not different from normal treatment
    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 Decision2006-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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