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出境医 / 临床实验 / the Hypertrophic Scar Prevention of BMT101.

the Hypertrophic Scar Prevention of BMT101.

Study Description
Brief Summary:
An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial

Condition or disease Intervention/treatment Phase
Hypertrophic Scar Drug: BMT101 Phase 2

Detailed Description:
As a comparative evaluation between the control group (untreated-control) and the study group (treatment) within a subject, it was decided to assign ten subjects to each of the three dose groups.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of BMT 101 Administration for the Prevention of Hypertrophic Scar
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: BMT101
BMT101 injection (treatment)
 Drug: BMT101
Intradermal injection to each of 3 dose-groups.
Other Name: cp-asiRNA
No Intervention: control
Un-treated control
Outcome Measures
Primary Outcome Measures :
  1. Reducing the hypertrophic scar after scar revision surgery [ Time Frame: Week 2, 6, 10, 22 ]
    to evaluate Differences in Visual Analogue Scale (VAS) score between the study group and the control group when independent evaluators assessed the severity of the hypertrophic scars.

  2. Safety evaluation of BMT101 [ Time Frame: Week 2, 6, 10, 22 ]
    To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female adults aged 19-55 years
  • Those who plan to undergo a revision surgery to remove hypertrophic scar resulted from a previous abdominal surgery
  • Those who voluntarily signed the written consent and agreed to participate in the study.

Exclusion Criteria:

  • Pregnant or lactating women
  • Those with clinically significant systemic disease (e.g. diabetes, hematologic disease, allergic or immunogenic systemic skin disease)
Contacts and Locations

Contacts
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Contact: Jinhong park +82-2-6966-1651 jhpark@hugel.co.kr

Locations
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Korea, Republic of
Hugel Recruiting
Seoul, Korea, Republic of
Contact: Korea         
Sponsors and Collaborators
Hugel
Tracking Information
First Submitted Date  ICMJE December 3, 2018
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE August 21, 2019
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • Reducing the hypertrophic scar after scar revision surgery [ Time Frame: Week 2, 6, 10, 22 ]
    to evaluate Differences in Visual Analogue Scale (VAS) score between the study group and the control group when independent evaluators assessed the severity of the hypertrophic scars.
  • Safety evaluation of BMT101 [ Time Frame: Week 2, 6, 10, 22 ]
    To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Hypertrophic Scar Prevention of BMT101.
Official Title  ICMJE An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of BMT 101 Administration for the Prevention of Hypertrophic Scar
Brief Summary An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial
Detailed Description As a comparative evaluation between the control group (untreated-control) and the study group (treatment) within a subject, it was decided to assign ten subjects to each of the three dose groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hypertrophic Scar
Intervention  ICMJE Drug: BMT101
Intradermal injection to each of 3 dose-groups.
Other Name: cp-asiRNA
Study Arms  ICMJE
  • Experimental: BMT101
    BMT101 injection (treatment)
    Intervention: Drug: BMT101
  • No Intervention: control
    Un-treated control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • male and female adults aged 19-55 years
  • Those who plan to undergo a revision surgery to remove hypertrophic scar resulted from a previous abdominal surgery
  • Those who voluntarily signed the written consent and agreed to participate in the study.

Exclusion Criteria:

  • Pregnant or lactating women
  • Those with clinically significant systemic disease (e.g. diabetes, hematologic disease, allergic or immunogenic systemic skin disease)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jinhong park +82-2-6966-1651 jhpark@hugel.co.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012099
Other Study ID Numbers  ICMJE HG-BMT-PIIa-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hugel
Study Sponsor  ICMJE Hugel
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hugel
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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