NCT03346902

Study of EB-001 in Facial Scar Reduction

A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Injections in Facial Scar Reduction After Undergoing Mohs Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Bonti, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Mohs Surgery

Interventions

Type	Name	Description
DRUG	EB-001	Injection of EB-001 into area of scarring (forehead)
DRUG	0.9% Sodium Chloride Injection	Injection of Saline into area of scarring (forehead)

Timeline

• Start date: 2018-02-06
• Primary completion: 2018-07-31
• Completion: 2018-10-08
• First posted: 2017-11-20
• Last updated: 2019-01-08
• Results posted: 2018-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study