Back to resultsthe Hypertrophic Scar Prevention of BMT101.
Primary Purpose
Hypertrophic Scar
Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BMT101
Sponsored by
About this trial
This is an interventional prevention trial for Hypertrophic Scar focused on measuring scar prevention, siRNA, scar
Eligibility 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)
Sites / Locations
- Hugel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
BMT101
control
Arm Description
BMT101 injection (treatment)
Un-treated control
Outcomes
Primary Outcome Measures
Reducing the hypertrophic scar after scar revision surgery
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
To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04012099
Brief Title
the Hypertrophic Scar Prevention of BMT101.
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Internal reasons
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hugel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar
Keywords
scar prevention, siRNA, scar
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMT101
Arm Type
Experimental
Arm Description
BMT101 injection (treatment)
Arm Title
control
Arm Type
No Intervention
Arm Description
Un-treated control
Intervention Type
Drug
Intervention Name(s)
BMT101
Other Intervention Name(s)
cp-asiRNA
Intervention Description
Intradermal injection to each of 3 dose-groups.
Primary Outcome Measure Information:
Title
Reducing the hypertrophic scar after scar revision surgery
Description
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.
Time Frame
Week 2, 6, 10, 22
Title
Safety evaluation of BMT101
Description
To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar
Time Frame
Week 2, 6, 10, 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Hugel
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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the Hypertrophic Scar Prevention of BMT101.
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