NCT04012099

Brief Summary

An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 21, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

May 24, 2023

Status Verified

July 1, 2022

Enrollment Period

3.7 years

First QC Date

December 3, 2018

Last Update Submit

May 22, 2023

Conditions

Hypertrophic Scar

Keywords

scar preventionsiRNAscar

Outcome Measures

Primary Outcomes (2)

  • 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.

    Week 2, 6, 10, 22

  • 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

    Week 2, 6, 10, 22

Study Arms (2)

BMT101

EXPERIMENTAL

BMT101 injection (treatment)

Drug: BMT101

control

NO INTERVENTION

Un-treated control

Interventions

BMT101DRUG

Intradermal injection to each of 3 dose-groups.

Also known as: cp-asiRNA
BMT101

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hugel

Seoul, South Korea

Location

MeSH Terms

Conditions

Cicatrix, HypertrophicCicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2018

First Posted

July 9, 2019

Study Start

August 21, 2019

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

May 24, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)