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

Phase 2 & 3

Waitlist Available

Led By Gautam Ghatnekar, PhD

Research Sponsored by FirstString Research, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6, month 9 and month 12

Summary

This trial is testing Granexin® gel, which is applied to surgical wounds to help reduce scarring. The study involves patients who have had surgery and are at risk of developing scars. The gel is used for a short period, and the patients are monitored for an extended time to see how well it works.

Eligible Conditions

Scar tissue
Scarring
Breast Reconstruction

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6, month 9 and month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6, month 9 and month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6, month 9 and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in scar severity at Month 12

Secondary study objectives

Change in scar severity at Month 6, Month 9 and Month 12

Change in scar severity at Month 9

Proportion of subjects with incision healing complications

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Granexin® gel 200 μMExperimental Treatment2 Interventions

Within-subject comparison of Granexin® Gel versus vehicle gel (placebo). Granexin® gel 200 μM will be applied four times over three days: twice during surgery, 24 hours after surgery and 48 hours after surgery. Granexin® will be applied on the right or left breast according to a randomization list.

Group II: Granexin® gel 100 μMExperimental Treatment2 Interventions

Within-subject comparison of Granexin® Gel versus vehicle gel (placebo). Granexin® gel 100 μM will be applied four times over three days: twice during surgery, 24 hours after surgery and 48 hours after surgery. Granexin® will be applied on the right or left breast according to a randomization list.

Group III: Vehicle GelPlacebo Group3 Interventions

Within-subject comparison of Granexin® Gel versus vehicle gel (placebo). Vehicle gel will be applied four times over three days: twice during surgery, 24 hours after surgery and 48 hours after surgery. Granexin® will be applied on the right or left breast according to a randomization list.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vehicle gel

2014

Completed Phase 4

~4560

Granexin® gel 100 μM

2020

Completed Phase 3

~190