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
|Condition or disease||Intervention/treatment||Phase|
|Mohs Surgery||Drug: EB-001 Drug: 0.9% Sodium Chloride Injection||Phase 2|
This study will evaluate the safety and efficacy of EB-001 in improving wound healing and reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead area following a single treatment of EB-001 when injected into the muscles underlying the incision area.
The safety objective is to determine the safety and tolerability of single treatment of EB-001 when injected into facial muscles underlying a surgical wound during Mohs surgery.
The efficacy objective is to evaluate the efficacy of a single treatment of EB-001 when injected into the facial muscles (frontalis) underlying the surgical wound in improving wound healing, and reducing scar formation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Injections in Facial Scar Reduction After Undergoing Mohs Surgery|
|Actual Study Start Date :||February 6, 2018|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||October 8, 2018|
Placebo Comparator: Placebo
Drug: : Placebo: 0.9% Sodium Chloride Injection
Injection of Placebo into area of scarring (forehead)
Drug: 0.9% Sodium Chloride Injection
Injection of Saline into area of scarring (forehead)
Active Comparator: EB001
Drug: EB-001 Injection of EB-001 into area of scarring (forehead)
Injection of EB-001 into area of scarring (forehead)
- Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best)) [ Time Frame: Day 30 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346902
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Study Director:||Earvin Liang||Bonti, Inc.|