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

NCT04331080 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2022-06-06

No results posted yet for this study

Summary

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

Conditions

  • Mammoplasty
  • Scarring
  • Scar
  • Breast Reconstruction

Interventions

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.

Sponsors & Collaborators

  • Xequel Bio, Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-05-26
Completion
2022-05-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331080 on ClinicalTrials.gov