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    Summary
    EudraCT Number:2015-002258-10
    Sponsor's Protocol Code Number:IBRB-02
    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:2016-09-01
    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
    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 number2015-002258-10
    A.3Full title of the trial
    SINCERE: A single-centre, assessor blind, randomised pilot study to evaluate the safety, tolerability and acceptability of RB Lotion compared to standard-of-care for Radiation Induced Skin Reactions (RISR), in subjects undergoing palliative external beam Radiotherapy (RT).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the degree to which a new product, RB Lotion, is safe, well tolerated and acceptable for treating Radiation Induced Skin Reactions (RISR) in subjects being treated with external beam radiotherapy, compared with their usual care.
    A.3.2Name or abbreviated title of the trial where available
    Radiation Induced Skin Reaction Study IBRB-02
    A.4.1Sponsor's protocol code numberIBRB-02
    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 SponsorDermal Laboratories Ltd
    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 organisationDermal Laboratories Ltd
    B.5.2Functional name of contact pointJennine Walker
    B.5.3 Address:
    B.5.3.1Street AddressDermal Laboratories Ltd,Tatmore Place, Gosmore,
    B.5.3.2Town/ cityHitchin, Herts
    B.5.3.3Post codeSG4 7QR
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01462458866
    B.5.5Fax number01462438707
    B.5.6E-mailclinical@dermal.co.uk
    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 Yes
    D.2.1.1.1Trade name Soleve Sunburn Relief
    D.2.1.1.2Name of the Marketing Authorisation holderDiomed Developments Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameRB Lotion
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Cutaneous emulsion
    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 INNIbuprofen
    D.3.9.1CAS number 15687-27-1
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIsopropyl myristate
    D.3.9.1CAS number 110-27-0
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Diprobase Cream
    D.2.1.1.2Name of the Marketing Authorisation holderBayer plc
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDiprobase Cream
    D.3.2Product code N/A
    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 INNNo pharmaceutically active ingredients
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeAS4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Radiation Induced Skin Reactions (RISR)
    E.1.1.1Medical condition in easily understood language
    Skin reaction as a result of radiation treatment. The affected areas become warm and red, and may also feel sore/itchy. The skin may also become dry and flaky and, in severe cases, broken and weeping.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10061103
    E.1.2Term Dermatitis radiation
    E.1.2System Organ Class 100000004863
    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 the safety and tolerability of the daily topical application of RB Lotion to the radiation treatment field compared to standard of care, Diprobase Cream, when used by subjects during their Radiotherapy treatment period.
    E.2.2Secondary objectives of the trial
    •To evaluate the effects of RB Lotion compared to Diprobase Cream in reducing RISR when administered in conjunction with radiotherapy.
    •To measure treatment acceptability as assessed by a questionnaire completed by the subject.
    •To measure plasma levels of ibuprofen associated with RB lotion treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or Female subjects ≥18 years;
    • Understand and voluntarily sign informed consent form prior to any study related assessments/procedures being conducted;
    • Scheduled to receive palliative external beam RT;
    • Treatment areas including only the thorax or limbs;
    • Anticipated treatment field is at least 8 cm in the superior/inferior and
    medial/lateral directions;
    • The planned total radiation dose does not exceed a planned prescribed dose of 20 Gy (prescribed for the mid-planar point) or a DMax of 30 Gy in no more than 5 Fractions of RT over no more than a 10 day period, using 6-10 MV photons (and a tissue equivalent bolus material is not used);
    • The subject or a carer must be able to administer the topical products to the treatment area;
    • The subject needs to have an anticipated life expectancy of greater than 3 months from date of randomisation;
    •The subject must be willing to abstain from the use of NSAIDs (systemic and topical other than Ibuprofen in study product or oral Aspirin up to a maximum daily dose of 75mg) from 72 hours prior to randomisation until at least Visit 7 or until the skin at the treatment site is assessed to be RTOG 0 on both sides if this is not confirmed at Visit 7. The restriction on the use of topical NSAIDS on or near the treatment site (as determined by the investigator) remains throughout the study;
    •The subject must be willing to abstain from the use of topical corticosteroids, on or near the treatment site (as determined by the investigator) from 72 hours prior to randomisation until the end of the study unless an assessment of RTOG 2A or 2B is confirmed (when specific local standard care corticosteroid treatment is permitted as per Section 7.7);
    • The subject must be willing to abstain from using emollients or moisturisers with the exception of study product, on or near the treatment site (as determined by the investigator) during the study.
    • The subject must be willing and able to comply with the study instructions and the study medication as directed and attend all scheduled visits;
    • Treatment area should not have any obvious breaks or lacerations in skin and should not be in an area of significant curvature of the skin surface (e.g. groin area) as assessed by the Investigator;
    • A score of RTOG 0 confirmed at the proposed treatment field;
    • Female subjects must have a negative urine pregnancy test at visit 1 unless they are surgically sterile or have been post menopausal for ≥ 1 year (12 consecutive months without menses).
    • Female subjects of childbearing potential must be using a highly effective and medically acceptable means of birth control and agree to continue its use for the duration of the study.
    A highly effective and medically acceptable method of birth control is defined as any form of contraception with a low failure rate defined as < 1% per year and for this study include;
    - combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal and transdermal) associated with inhibition of ovulation.
    - progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation
    - intrauterine device (IUD)
    - intrauterine hormone-releasing system ( IUS)
    - bilateral tubal occlusion
    - sexual abstinence as defined as refraining from heterosexual intercourse for the duration of the study
    E.4Principal exclusion criteria
    • Concurrent participation in another interventional clinical study, or participation within 30 days before Visit 1 of this study;
    • Subjects who have active dermatitis involving the treatment area;
    • Patients with known radiation sensitivity syndromes e.g. Ataxia telangiectasia, Fanconi’s Anaemia, etc;
    • Subjects who have used systemic or topical NSAIDs other than oral Aspirin (maximum daily dose of 75mg) within the 72 hours prior to randomisation;
    •Subjects who have used topical corticosteroids on or near the treatment site (as determined by the investigator) within the 72 hours prior to randomisation;
    • Subjects who have atrophy of the skin involving the treatment area;
    • Subjects who have signs of ongoing bacterial, viral or fungal infection of the skin involving the treatment area;
    • Subjects who have undergone RT within the previous 6 weeks or are receiving concurrent chemotherapy;
    • The current treatment field is within 2cm of a previous treatment field;
    • Presence of skin involvement by tumour;
    • Subjects who have previously had a radiation-related skin reaction greater than RTOG 2A;
    • The anticipated life expectancy is less than 3 months;
    • An ECOG performance status score of 4;
    • If the subject is pregnant or lactating;
    • If the subject has a clinically relevant history of hypersensitivity, allergy or contraindications to ibuprofen or any of the excipients of RB Lotion or Diprobase Cream. This includes known sensitivity to aspirin or other NSAID painkillers (including when taken by mouth), especially where associated with a history of asthma, rhinitis, urticaria, an active peptic ulcer or a history of kidney problems.
    • Those who in the opinion of the Investigator are unsuitable for participation in the study or exhibit other factors limiting their ability to co-operate and to comply with the protocol;
    • Employees of the Investigator, trial site, CRO, or sponsor, as well as family members of the employees or the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Safety evaluated by differential in the grade of skin reaction between the RB Lotion and Diprobase Cream treated skin surfaces as measured by the Radiation Therapy Oncology Group (RTOG) skin reaction scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    RTOG will be assessed by the Investigator at Visits 1 (before radiation treatment, RT), 6 (last RT day), 7 (1 week post- RT follow-up) and at any unscheduled assessments. It may also be assessed at Visits 8 to 13 (weekly up to 6 weeks post-RT follow-up visits) should the subject continue to experience RISR symptoms (RTOG 0 not confirmed).
    E.5.2Secondary end point(s)
    • Differential in the duration (measured in days) of each grade of skin reaction between the RB Lotion and Diprobase Cream treated skin surfaces as measured by the RTOG skin reaction scale.

    • Subject compliance with the study medication.

    • Patient reported outcomes (RISR Symptoms Assessment Questionnaire & Treatment Acceptability Questionnaire).

    • Any serious adverse events, including grade 3 RTOG skin reaction.

    • Plasma levels of ibuprofen at final day of Radiotherapy treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    RTOG will be assessed by the Investigator at Visits 1 (before radiation treatment, RT), 6 (last RT day), 7 (1 week post-RT follow-up) and at any unscheduled assessments. It may also be assessed at Visits 8 to 13 (weekly up to 6 weeks post-RT follow-up visits) should the subject continue to experience RISR symptoms (RTOG 0 not confirmed).

    The RISR Symptoms Assessment Questionnaire will be given to the patients for completion at Visits 1, 6 & 7 and at each subsequent visit for subjects who have not had RTOG 0 confirmed.

    The Treatment Acceptability Questionnaire will be given to subjects to complete at the visit where RTOG 0 is confirmed (no earlier than visit 7 and no later than Visit 13).

    Plasma levels of ibuprofen will be determined at Visit 6.
    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 Yes
    E.6.13.1Other scope of the trial description
    Acceptability
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Bilateral (within subject) comparison
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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 No
    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
    Last Subject Last Visit or Last Subject Last Contact - This will depend on whether the last enrolled patient has achieved RTOG 0 at Visit 12 or before. if this is the case the last contact can be via phone with the subject. However if the subject had not achieved RTOG 0 at their Visit 12, then an on-site Visit 13 is required.
    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 months3
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    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)
    If any further RISR treatment or associated intervention is required beyond Visit 13 (end of study visit), this will be undertaken as part of standard care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-10
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