the Hypertrophic Scar Prevention of BMT101.

Hypertrophic Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04012099
• Other study ID #: HG-BMT-PIIa-01
• Status: Terminated
• Phase: Phase 2
• Start date: August 21, 2019
• Est. completion date: May 10, 2023

Study information

• Verified date: July 2022
• Source: Hugel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 10, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy

Intervention

Drug:
• BMT101
Intradermal injection to each of 3 dose-groups.

Locations

Country	Name	City	State
Korea, Republic of	Hugel	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 2, 6, 10, 22
Primary	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	Week 2, 6, 10, 22