ClinicalTrials.gg
TerminatedNCT04012099Updated May 24, 2023

the Hypertrophic Scar Prevention of BMT101.

A Phase 2 interventional study of BMT101 in Hypertrophic Scar, sponsored by Hugel. Terminated at 1 site in Korea, Republic of. Open to participants aged 19 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Hugel · Phase 2, Interventional, and Prevention

Why this study was terminated
Internal reasons
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hypertrophic Scar

Keywords

  • scar prevention
  • siRNA
  • scar
03

In context

Cicatrix, Hypertrophic

129 studies on the registry are indexed under Cicatrix, Hypertrophic; 31 are open to participants now.

This study's enrollment of 20 is below the median of 36 across 106 interventional studies indexed under Cicatrix, Hypertrophic.

Browse Cicatrix, Hypertrophic studies →

Lead sponsor

Hugel is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnant or lactating women
  • Those with systemic disease (e.g. diabetes, hematologic disease, allergic or immunogenic systemic skin disease)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    BMT101

    BMT101 injection (treatment)

    Drug: BMT101

  • No intervention
    control

    Un-treated control

Interventions

  • DrugBMT101

    Intradermal injection to each of 3 dose-groups.

    Also known as: cp-asiRNA

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 2, 6, 10, 22

  2. 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

    Time frame: Week 2, 6, 10, 22

07

Study locations

1 site
  • Hugel
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04012099
Lead sponsor
Hugel
Responsible party
Sponsor
First posted
Jul 9, 2019
Start date
Aug 21, 2019
Primary completion
May 10, 2023
Completion
May 10, 2023
Last update
May 24, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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