the Hypertrophic Scar Prevention of BMT101.

NCT ID: NCT04012099

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-21

Study Completion Date

2023-05-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertrophic Scar

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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BMT101

BMT101 injection (treatment)

Group Type EXPERIMENTAL

BMT101

Intervention Type DRUG

Intradermal injection to each of 3 dose-groups.

control

Un-treated control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BMT101

Intradermal injection to each of 3 dose-groups.

Intervention Type DRUG

Other Intervention Names

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cp-asiRNA

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hugel

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hugel

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HG-BMT-PIIa-01

Identifier Type: -

Identifier Source: org_study_id

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