the Hypertrophic Scar Prevention of BMT101.

Hugel

Status and phase: Terminated; Phase 2

Conditions: Hypertrophic Scar

Treatments: Drug: BMT101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04012099

HG-BMT-PIIa-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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20 participants in 2 patient groups

BMT101

Experimental group

Description:

BMT101 injection (treatment)

Treatment:

Drug: BMT101

control

No Intervention group

Description:

Un-treated control