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Granexin® gel 200 μM for Scarring

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
Awards & highlights

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
  • Scarring
  • Breast Reconstruction

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in scar severity at Month 12
Secondary outcome measures
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
Granexin® gel 200 μM
2020
Completed Phase 3
~190

Find a Location

Who is running the clinical trial?

FirstString Research, Inc.Lead Sponsor
6 Previous Clinical Trials
229 Total Patients Enrolled
Xequel Bio, Inc.Lead Sponsor
6 Previous Clinical Trials
229 Total Patients Enrolled
Gautam Ghatnekar, PhDPrincipal InvestigatorFirstString Research, Inc.
1 Previous Clinical Trials
~36 spots leftby Sep 2025
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