the Hypertrophic Scar Prevention of BMT101.

Phase 2TerminatedNCT04012099

Hugel20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Hypertrophic Scar

Interventions

BMT101DRUG

Intradermal injection to each of 3 dose-groups.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 Years

Medical Language ↔ Plain English

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)

Locations (1)

Hugel

Seoul, South Korea

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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