Status:
TERMINATED
the Hypertrophic Scar Prevention of BMT101.
Lead Sponsor:
Hugel
Conditions:
Hypertrophic Scar
Eligibility:
All Genders
19-55 years
Phase:
PHASE2
Brief Summary
An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- Pregnant or lactating women
- Those with clinically significant systemic disease (e.g. diabetes, hematologic disease, allergic or immunogenic systemic skin disease)
Key Trial Info
Start Date :
August 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04012099
Start Date
August 21 2019
End Date
May 10 2023
Last Update
May 24 2023
Active Locations (1)
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1
Hugel
Seoul, South Korea