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

COMPLETEDPHASE2/PHASE3

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

NCT04331080•Xequel Bio, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Female subjects aged 18 years and older
•2. Female subjects of childbearing potential must have a negative urine or blood pregnancy test at screening and baseline.
•3. Female subjects of childbearing potential must agree to use ONE of the following birth control methods throughout the study:
•* abstinence
•* condom with spermicide
•* diaphragm with spermicide
•* Hormonal contraceptive
•* intra-uterine device
•Non-childbearing confirmed by prior documentation of at least one of the following:
•* postmenopausal
+3 more criteria

Exclusion Criteria

•1. Subjects with breast implants or history of breast implants
•2. Subjects undergoing breast surgery requiring breast implants
•3. Subjects requiring nipple grafting using any technique
•4. Subjects with a history of infection in the past 6 months in the intended area of incision
•5. Subjects with breast tattoos in the intended area of the incision
•6. Subjects with known skin sensitivity to Tegaderm™
•7. Subjects with a history of keloids
•8. Known conditions of collagen vascular diseases
•9. Subjects with clinically significant medical conditions as determined by the Investigator, which would impair wound healing including renal, hepatic, hematologic, neurologic or autoimmune disease. Examples include but are not limited to:
•1. Renal insufficiency as an estimated GFR, which is \< 30 mL/min/1.7m2
+16 more criteria

Locations (11)

Private Clinic- David Kulber

Los Angeles, California, United States

Pasadena Surgeons

Pasadena, California, United States

Universal Axon Clinical Research

Doral, Florida, United States

Miami Plastic Surgery

Miami, Florida, United States

Ibrahim H. Amjad, MD, PA

West Miami, Florida, United States

Northwestern University - Feinberg School of Medicine - Division of Plastic & Reconstructive Surgery

Chicago, Illinois, United States

Iowa Plastic Surgery

Davenport, Iowa, United States

Luxurgery

New York, New York, United States

Wake Forest Baptist Hospital - Plastic and Reconstructive Surgery

Winston-Salem, North Carolina, United States

Integrated Aesthetics

Spring, Texas, United States

Key Dates

Start Date

July 1, 2020

Primary Completion Date

May 26, 2022

Completion Date

May 26, 2022

Last Updated

June 6, 2022

Enrollment

184

ACTUAL participants

Conditions

MammoplastyScarringScarBreast Reconstruction

Interventions

Granexin® gel 100 μM

DRUG

Granexin® gel 200 μM

DRUG

Vehicle gel

DRUG

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Infertility, FemaleRecurrent Miscarriage+1 more

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RECRUITINGNA

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Acne Scars

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RECRUITINGPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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