Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-002920-23
    Sponsor's Protocol Code Number:CLS001-CO-PR-005
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-03
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-002920-23
    A.3Full title of the trial
    A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects with Papulopustular Rosacea with a 4 Week Follow-up Period
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects with Papulopustular Rosacea with a 4 Week Follow-up Period
    A.4.1Sponsor's protocol code numberCLS001-CO-PR-005
    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 SponsorCutanea Life Sciences, Inc.
    B.1.3.4CountryUnited States
    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 supportCutanea Life Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCutanea Life Sciences, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address1500 Liberty Ridge, Suite 3000
    B.5.3.2Town/ cityWayne, PA
    B.5.3.3Post code19087
    B.5.3.4CountryUnited States
    B.5.4Telephone number+14845882306
    B.5.6E-mailjphillips@cutanealife.com
    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 nameOmiganan Topical Gel
    D.3.2Product code CLS001
    D.3.4Pharmaceutical form Gel
    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 INNOmiganan Pentahydrochloride
    D.3.9.1CAS number 269-062-93-3
    D.3.9.2Current sponsor codeCLS-001
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.6
    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 placeboGel
    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
    Papulopustular Rosacea
    E.1.1.1Medical condition in easily understood language
    Papulopustular Rosacea is a chronic dermatologic disorder that primarily
    affects the facial skin with inflammatory papules and pustules.
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10039218
    E.1.2Term Rosacea
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and efficacy of once daily application of omiganan topical gel compared to vehicle topical gel in subjects with papulopustular rosacea
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who provided written informed consent to participate in the study.
    2. Healthy, male and non-pregnant female subjects, 18 years of age or older.
    3. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions (papules, pustules) at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
    4. Subjects with the presence of telangiectasia at Baseline.
    5. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema (IAE) scale at Baseline.
    6. Subjects with a grade 4 (severe rosacea) on the 5-point Investigators Global Assessment (IGA) scale at Baseline.
    7. Non-nursing, female subjects of child bearing potential, who are using a highly effective form of birth control or females not of childbearing potential due to menopause (must be postmenopausal for at least one year).
    • Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Forms of birth control include: Oral (birth control pills), Intravaginal: (e.g. NuvaRing®), Implantable (e.g. Norplant®), injectable (e.g. Depo-Provera®) or transdermal (e.g. Ortho Evra®) contraception; intrauterine device (IUD); double-barrier (diaphragm or condom with spermicidal gel or foam); for two months prior to study enrollment (see exclusion criteria #6) or a vasectomized partner or true abstinence (in line with preferred and usual lifestyle of subject) with an acceptable form of birth control should the subject become sexually active. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. All female subjects of child bearing potential must undergo an in-office, highly sensitive urine pregnancy test, with a negative result, prior to being randomized to receive study drug. In addition, women of childbearing potential must agree to have a highly sensitive urine pregnancy test at the end of the study.
    8. Subjects who have used the same brand of soap, make-up, hair products, or shaving lotion/foam/cream/gel for a period of at least four weeks prior to the Baseline Visit and agree not to change these product brand/types during the study.
    9. Male subjects who are willing to shave, if applicable, at approximately the same time every day.
    10. Subjects who are willing and able to return to the study clinic for the designated study visits.
    11. Subjects who are willing to refrain from sunbathing, using sun tanning booths/beds, or excessive exposure to the sun for the duration of the study.
    12. Subjects who are willing to comply with the protocol and visit requirements.
    E.4Principal exclusion criteria
    1. Subjects with clinically significant abnormal findings at the Baseline/Day 1 Visit that would require a new intervention or treatment or a change in treatment that would in the opinion of the investigator supersede participation in the clinical trial.
    2. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
    3. Subjects with nodular rosacea (defined as more than 2 lesions greater than 5 mm).
    4. Subjects with underlying diseases or other dermatological conditions, such as; atopic dermatitis, perioral dermatitis, or seborrheic dermatitis, which requires the use of interfering topical or systemic therapy or may interfere with the rosacea diagnosis or its assessment.
    5. Subjects using concomitant treatments that may influence study end points within 2 weeks of the Baseline Visit (e.g., facial or chemical peels, dermal fillers, acne surgery, intralesional steroids, spironolactone, debridement, cryotherapy, dermabrasion, X-ray, laser therapy or UV therapy).
    6. If using estrogens or progesteronal agents (e.g, Gynogen, Valergen, Depo-Testadiol, Depogen, birth control pills), for less than 2 months prior to the Baseline Visit. (Subjects using estrogens for 2 months or more need not be excluded unless the subject expects to change dose, drug, or discontinue estrogen use during the study. See Inclusion #7)
    7. Subjects with known allergies to the active ingredient or any of the excipients. (See Section7.6.2)
    8. Subjects who have not undergone the specified washout period(s) for the following topical preparations applied to the face or subjects who require the concomitant use of any of the following topical preparations/treatments applied to the face:
    Product Washout Period
    (Prior to Baseline/First Dose)
     Abradants, astringents, toners, facials, masks, or moisturizers
    containing retinols, AHA (alpha hydroxyl acids),
    salicylic acids, 1 week
     Tanning booths/beds 2 weeks
     Antibiotics (other than topical ocular application) 2 weeks
     Antimicrobial soaps 2 weeks
     Corticosteroids 2 weeks
     Other anti-inflammatories 2 weeks
     Other rosacea treatments (e.g., azelaic acid,
    metronidazole, ivermectin, sulfacetamide) 2 weeks
     Retinoids 4 weeks
    9. Subjects who have not undergone the specified washout period(s) for the following systemic treatments or subjects who require the concomitant use of any of the following systemic treatments:
    Product Washout Period
    (Prior to Baseline/First Dose)
     Antibiotics 4 weeks
     Corticosteroids 4 weeks
     Retinoids 12 weeks
    10. Female subjects who are pregnant, nursing, or planning a pregnancy within the study period.
    11. Subjects who have a beard, or excessive facial hair. A moustache will be allowed, if in the investigator’s judgment it does not impair the assessment of rosacea.
    12. Subjects using an investigational drug within 30 days of the Baseline Visit or who are currently participating in an investigational study. Use of an investigational drug/device and/or participation in another investigational study is prohibited during this study.
    13. Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol or drug abuse with in the past year.
    14. Subjects who have a chronic medical condition that may require the use of a prohibited medication to treat new symptoms or exacerbations.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints
    Co-primary Endpoints
    o The absolute change from Baseline to Week 12 in inflammatory lesions.
    o IGA at Week 12: 2 grade reduction; Clear or almost Clear (IGA 0, or 1)
    Safety Endpoints:
    Adverse events (AE) throughout the study; vital signs at Screening, Week 6 and Week 12; Physical Exam and Safety labs at Screening and Week 12. Immunogenicity will be assessed using samples collected at Baseline, and at Weeks 3, 6, 12 and 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 of treatment
    E.5.2Secondary end point(s)
    The absolute change from baseline to Week 9 in inflammatory lesions (papules and pustules).
    o The absolute change from baseline to Week 6 in inflammatory lesions (papules and pustules).
    o IGA at Week 9: 2 point reduction; Clear or Almost Clear (IGA 0, 1).
    o IGA at Week 6: 2 point reduction; Clear or Almost Clear (IGA 0, 1).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 6 and 9 of 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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Vehicle Controlled
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    France
    Germany
    Ireland
    Netherlands
    New Zealand
    Sweden
    United Kingdom
    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
    The definition of the end of the study in the protocol is LVLS. Please note if any subjects have a positive antidrug antibody results they will be followed for up to 1 year from the last study medication use to allow for antibody levels to return to baseline. During this time period, samples will be collected every 3 months
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 272
    F.4.2.2In the whole clinical trial 450
    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)
    Once a subject has completed their participation in the study they will be treated as per standard medical practice for this patient population
    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 Decision2015-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-20
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 06 00:02:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA