the Hypertrophic Scar Prevention of BMT101.

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04012099

Enrollment

Registered

2019-07-09

Start date

2019-08-21

Completion date

2023-05-10

Last updated

2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Scar

Keywords

scar prevention, siRNA, 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.

Interventions

DRUGBMT101

Intradermal injection to each of 3 dose-groups.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Reducing the hypertrophic scar after scar revision surgery	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	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026