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    Summary
    EudraCT Number:2017-003118-15
    Sponsor's Protocol Code Number:97807
    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:2017-08-16
    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 number2017-003118-15
    A.3Full title of the trial
    A double blind, placebo controlled, randomised dose escalation trial to investigate the safety and efficacy of topical salbutamol in the improvement of scar appearance when applied to approximated wound margins in healthy volunteers.

    Short title: A trial to assess the safety and efficacy of topical salbutamol in healthy volunteers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double blind, placebo controlled, randomised dose escalation trial to investigate the safety and efficacy of topical salbutamol in the improvement of scar appearance when applied to approximated wound margins in healthy volunteers
    A.3.2Name or abbreviated title of the trial where available
    SSCART
    A.4.1Sponsor's protocol code number97807
    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 SponsorUniversity Hospitals of Leicester NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical Research Council
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProTherax Ltd
    B.5.2Functional name of contact pointDavid Fairlamb
    B.5.3 Address:
    B.5.3.1Street Address3 Stepping Stones
    B.5.3.2Town/ cityEast Morton, Keighley
    B.5.3.3Post codeBD20 5UG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01274561815
    B.5.6E-maildavidfairlamb@protherax.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 nameSalbutamol Gel 2.5mM
    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 INNSalbutamol sulfate
    D.3.9.1CAS number 18559-94-9
    D.3.9.3Other descriptive nameAlbuterol
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mmol millimole(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) 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 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 nameSalbutamol Gel 5mM
    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 INNSalbutamol sulfate
    D.3.9.1CAS number 18559-94-9
    D.3.9.3Other descriptive nameAlbuterol
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mmol millimole(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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: 3
    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 nameSalbutamol Gel 10mM
    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 INNSalbutamol sulfate
    D.3.9.1CAS number 18559-94-9
    D.3.9.3Other descriptive nameAlbuterol
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mmol millimole(s)
    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.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
    Improvement of (hypertrophic)scar appearance
    E.1.1.1Medical condition in easily understood language
    Improvement of scar appearance
    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 PT
    E.1.2Classification code 10020879
    E.1.2Term Hypertrophic scar
    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
    The primary objective of the study is to assess the safety and tolerance of topically applied salbutamol gel, when applied topically to the approximated wound margins of male and female subjects following surgical incisions.
    E.2.2Secondary objectives of the trial
    To determine the optimal concentration and efficacy of topical salbutamol gel, for the improvement of the resultant scar, when applied to the approximated wound margins of male and female subjects, following surgical incisions and daily thereafter, for 2 months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able, in the opinion of the investigator, and willing to give informed consent
    2. Aged 18-50 inclusive, with both arms
    3. Participants registered on the The Over Volunteering Prevention System (TOPS)or equivalent in Leicester.
    4. Body mass index with the range of 15-35 kg per square metre
    5. In the opinion of the investigator, clinically acceptable results for the laboratory tests specified in the trial protocol. All laboratory tests must be performed within 28 days of the subject's first trial dose administration.
    6. Women of child bearing potential (WOCBP) must be using a highly effective* means of contraception and agree to do so from at least the screening visit until trial end or completion of the trial.

    * Women of childbearing potential (WOCBP) will be required to use highly effective contraceptive measures (i.e. a failure rate of less than 1% per year when used consistently and correctly) before being enrolled into the study. In line with guidance, this has been clearly defined as:
    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
    - oral
    - intravaginal
    - transdermal
    • progestogen-only hormonal contraception associated with inhibition of ovulation:
    - oral
    - injectable
    - implantable
    • intrauterine device (IUD)
    • intrauterine hormone-releasing system (IUS)
    • bilateral tubal occlusion
    • vasectomised partner (provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the surgical success)
    • sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
    E.4Principal exclusion criteria
    1. On direct questioning, have evidence of Left/Right confusion
    2. On direct questioning and/or physical examination a history or evidence of keloid scarring
    3. On direct questioning have a family history of keloid scarring.
    4. Tattoos or previous scars within 3cm of the area to be incised during the trial.
    5. Surgery in the area to be incised and have surgical scars within 3cm of this area.
    6. History of a bleeding disorder or who are receiving anti-coagulant or anti-platelet therapy.
    7. On direct questioning and physical examination, have evidence of any past or present clinically significant disease that may affect the endpoints of the trial. For example coagulation disorders, diabetes, immuno-mediated conditions or allergies including contact dermatitis.
    8. Subjects with a clinically significant skin disorder (dermatitis, eczema, psoriasis) that is chronic or currently active and which the investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
    9. Any clinically significant medical condition or history that would impair wound healing including: Rheumatoid arthritis, chronic renal impairment for their age, hepatic impairment (LFTs >3 times upper limit of normal),congestive heart failure, pre-existing ischaemic heart disease, pulmonary hypertension, hypertrophic obstructive cardiomyopathy, aortic stenosis, current active malignancy or history of malignancy in the last 5 years, immunosuppression or chemotherapy within the last 12 months, a history of radiotherapy at the areas to be studies, diabetes mellitus, and subjects with a proven diagnosis of thyroid disease.
    10. A history of hypersensitivity to any of the drugs or dressings used in the trial.
    11. Other prescribed treatments including all corticosteroids, other salbutamol containing preparations, other beta-agonists, any beta-blockers, adrenaline.
    12. Undergoing investigations or changes in management for an existing medical condition
    13. History of drug abuse, including cocaine, amphetamines, methamphetamines, opiates or benzodiazepines.
    14. In the opinion of the investigator, are unlikely to complete the trial for whatever reason
    15. Any clinically significant neurological impairment or disease, including body dysmorphia.
    16. At entry into the trial, any active infection
    17. Pregnant or lactating or planning to become pregnant during the duration of the trial.
    18. Not involved with any other clinical trial of medicinal product at the time of consent or 3 months prior.
    E.5 End points
    E.5.1Primary end point(s)
    The primary trial outcome will be
    • Binary outcome of whether Salbutamol peak plasma concentration in the 24 hours following gel administration at day 0 is less than 30ng/ml or not

    E.5.1.1Timepoint(s) of evaluation of this end point
    The pharmacokinetic analysis will be assessed at 0 (baseline), 10, 30, 60 minutes and at 2, 4, 8 and 24 hours after first administration (day 0) and at 10, 30, 60 minutes and at 2, 4, 8 and 24 hours after Day 10 application
    E.5.2Secondary end point(s)
    Secondary endpoints, will include:
    • Binary outcome of whether Salbutamol peak plasma concentration in the 24 hours following gel administration at day 10 is less than 30ng/ml or not
    •GSCS scores between drug and placebo, assessed by the clinical investigator at Month 7.
    •GSCS scores between drug and placebo, assessed by the clinical investigator at Month 9.
    •GSCS scores between drug and placebo, assessed by the clinical investigator at Month 12.
    •GSCS scores between drug and placebo, assessed by the subject at Month 7.
    •GSCS scores between drug and placebo, assessed by the subject at Month 9
    •GSCS scores between drug and placebo, assessed by the subject at Month 12
    •Differences in Patient & Observer Scar Assessment Scale (POSAS) scores at Month 9
    •Differences in POSAS scores at Month 12
    •Differences in objective assessments of scar colour, width, area and height (profilometry) at Month 9
    •Differences in objective assessments of scar colour, width, area and height (profilometry) at Month 12
    •Rate of local adverse events, between drug and placebo sites up to and including Month 3
    •Rate of adverse events in first 3 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints for safety (local adverse events) will be assessed at Month 3 (1 months after completion of dosing). Efficacy endpoints will be assessed between 7 and 12 months after surgery.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Within participant
    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.8.2.4Number of treatment arms in the trial3
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    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: 45
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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)
    Participants will be monitored throughout the 12-month period of the study. Where appropriate, rescue treatment for poor scar outcome(silicone sheeting)has been defined within the clinical protocol. Other treatments, as appropriate, will be made via referral to the subjects GP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-01
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