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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Mammoplasty, Scarring, Scar, Breast Reconstruction

In brief

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

Key facts

Study ID

NCT04331080

Run by

Xequel Bio, Inc.

People needed

184

Starts

2020-07-01

Expected to finish

2022-05-26

Last updated by the study team

2022-06-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female subjects aged 18 years and older
• Female subjects of childbearing potential must have a negative urine or blood pregnancy test at screening and baseline.
• 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
• surgically sterilized
• Subjects undergoing a breast surgery procedure with bilateral anchor incisions
• Signed informed consent form

You may not qualify if…

• Subjects with breast implants or history of breast implants
• Subjects undergoing breast surgery requiring breast implants
• Subjects requiring nipple grafting using any technique
• Subjects with a history of infection in the past 6 months in the intended area of incision
• Subjects with breast tattoos in the intended area of the incision
• Subjects with known skin sensitivity to Tegaderm™
• Subjects with a history of keloids
• Known conditions of collagen vascular diseases
• 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:
• Renal insufficiency as an estimated GFR, which is < 30 mL/min/1.7m2
• Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range
• Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/L
• Hemoglobin < 9 g/dL
• Hematocrit < 30%
• Platelet count < 100,000 μL
• Any history within the last 5 years or the presence of any active systemic cancer (with the exception of non-melanoma skin cancer)
• Current treatment with systemic corticosteroids (>15 mg/day). Washout period is 30 days prior to screening
• Current treatment with biologic immunosuppressive agents or chemotherapeutic agents. Wash out period for short term immunosuppressive agents is 14 days prior to screening
• Previous history of radiation therapy to the chest
• Known inability to complete required study visits during study participation
• A psychiatric condition (e.g., suicidal ideation), chronic alcohol consumption, or drug abuse problem determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance
• Use of any investigational drug or therapy within the 28 days prior to screening
• History of previous breast surgeries in the area where the incisions are to be made
• Currently pregnant, pregnant during the 6 months prior to screening, lactating, or breastfeeding
• Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in the study

Where it is running

• 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
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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