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Study of EB-001 in Facial Scar Reduction

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ClinicalTrials.gov Identifier: NCT03346902
Recruitment Status : Completed
First Posted : November 20, 2017
Results First Posted : December 14, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Bonti, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Mohs Surgery
Interventions Drug: EB-001
Drug: 0.9% Sodium Chloride Injection
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo EB001
Hide Arm/Group Description 0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead) EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead).
Period Title: Overall Study
Started 4 8
Completed 4 8
Not Completed 0 0
Arm/Group Title Placebo EB001 Total
Hide Arm/Group Description 0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead) EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead) Total of all reporting groups
Overall Number of Baseline Participants 4 8 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 8 participants 12 participants
67
(60 to 75)
59
(34 to 72)
62
(34 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 12 participants
Female
2
  50.0%
3
  37.5%
5
  41.7%
Male
2
  50.0%
5
  62.5%
7
  58.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
8
 100.0%
12
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 8 participants 12 participants
4
 100.0%
8
 100.0%
12
 100.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 4 participants 8 participants 12 participants
87.28  (25.528) 79.94  (19.352) 82.38  (21.055)
1.Primary Outcome
Title Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best))
Hide Description Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 30. Percentage of subjects reporting an improvement in Visual Analog Scale score.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Placebo EB001
Hide Arm/Group Description:
0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)
EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead)
Overall Number of Participants Analyzed 4 8
Measure Type: Number
Unit of Measure: Percentage reporting improvement
0 50
Time Frame 90 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo EB001
Hide Arm/Group Description 0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead) EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead)
All-Cause Mortality
Placebo EB001
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo EB001
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo EB001
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      1/8 (12.50%)    
Nervous system disorders     
Asymmetry in facial features as a result of the temporal nerve being affected during the Mohs Surger *  0/4 (0.00%)  0 1/8 (12.50%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wajdie Ahmad
Organization: Bonti
Phone: 9493796569 ext 9493796569
EMail: wajdie@bonti.com
Layout table for additonal information
Responsible Party: Bonti, Inc.
ClinicalTrials.gov Identifier: NCT03346902     History of Changes
Other Study ID Numbers: EB001-SR201
First Submitted: November 13, 2017
First Posted: November 20, 2017
Results First Submitted: October 17, 2018
Results First Posted: December 14, 2018
Last Update Posted: January 8, 2019