NCT04331080

A Study of Granexin® Gel for the Reduction of Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery

A Phase 2b/3 Randomized, Prospective, Double Blind, Within-Subject Vehicle Controlled, Multi-Center Study to Determine the Efficacy and Safety of Granexin® Gel in Reducing Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Xequel Bio, Inc. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.

Detailed description

Participants that meet screening criteria will be eligible for randomization providing all other criteria are met. Participants enrolled will receive study drug for 3 days. The participants will have an additional follow-up period to assess scarring of both Granexin® gel and Vehicle gel incisions through end of study at Month 12.

Conditions

• Mammoplasty
• Scarring
• Scar
• Breast Reconstruction

Interventions

Type	Name	Description
DRUG	Granexin® gel 100 μM	Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
DRUG	Granexin® gel 200 μM	Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
DRUG	Vehicle gel	Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-05-26
• Completion: 2022-05-26
• First posted: 2020-04-02
• Last updated: 2022-06-06

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study