the Hypertrophic Scar Prevention of BMT101.

May 22, 2023 updated by: Hugel

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMT101
BMT101 injection (treatment)
Drug: BMT101
Intradermal injection to each of 3 dose-groups.
Other Names:
  • cp-asiRNA
No Intervention: control
Un-treated control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reducing the hypertrophic scar after scar revision surgery
Time Frame: Week 2, 6, 10, 22
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
Safety evaluation of BMT101
Time Frame: Week 2, 6, 10, 22
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hugel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2019

Primary Completion (Actual)

May 10, 2023

Study Completion (Actual)

May 10, 2023

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

July 4, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HG-BMT-PIIa-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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