Suspended
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
What is being tested
BMT101
Drug
Who is being recruted
Cicatrix+2
+ Fibrosis
+ Pathologic Processes
From 19 to 55 Years
+5 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 2
Interventional
Study Start: August 2019
Summary
Principal SponsorHugel
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 21, 2019
Actual date on which the first participant was enrolled.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.
Official TitleAn 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
Principal SponsorHugel
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 19 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsCicatrix, Hypertrophic
Criteria
3 inclusion criteria required to participate
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.
2 exclusion criteria prevent from participating
Pregnant or lactating women
Those with clinically significant systemic disease (e.g. diabetes, hematologic disease, allergic or immunogenic systemic skin disease)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalBMT101 injection (treatment)
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
SuspendedOne Study Center