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

Last updated: June 2, 2022
Sponsor: Xequel Bio, Inc.
Overall Status: Completed

Phase

2/3

Condition

Breast Reconstruction

Pressure Ulcer

Treatment

N/A

Clinical Study ID

NCT04331080
2019-SCAR-01
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female subjects aged 18 years and older
  2. Female subjects of childbearing potential must have a negative urine or bloodpregnancy test at screening and baseline.
  3. Female subjects of childbearing potential must agree to use ONE of the following birthcontrol 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
  1. Subjects undergoing a breast surgery procedure with bilateral anchor incisions
  2. Signed informed consent form

Exclusion

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 ofincision
  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 theInvestigator, which would impair wound healing including renal, hepatic, hematologic,neurologic or autoimmune disease. Examples include but are not limited to:
  10. Renal insufficiency as an estimated GFR, which is < 30 mL/min/1.7m2
  11. Abnormal blood biochemistry defined as 3 times that of the upper limit of thenormal range
  12. Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25g/L
  13. Hemoglobin < 9 g/dL
  14. Hematocrit < 30%
  15. Platelet count < 100,000 μL
  16. Any history within the last 5 years or the presence of any active systemic cancer (with the exception of non-melanoma skin cancer)
  17. Current treatment with systemic corticosteroids (>15 mg/day). Washout period is 30days prior to screening
  18. Current treatment with biologic immunosuppressive agents or chemotherapeutic agents.Wash out period for short term immunosuppressive agents is 14 days prior to screening
  19. Previous history of radiation therapy to the chest
  20. Known inability to complete required study visits during study participation
  21. A psychiatric condition (e.g., suicidal ideation), chronic alcohol consumption, ordrug abuse problem determined from the subject's medical history, which, in theopinion of the Investigator, may pose a threat to subject compliance
  22. Use of any investigational drug or therapy within the 28 days prior to screening
  23. History of previous breast surgeries in the area where the incisions are to be made
  24. Currently pregnant, pregnant during the 6 months prior to screening, lactating, orbreastfeeding
  25. Any other factor, which may, in the opinion of the Investigator, compromiseparticipation and follow-up in the study
  26. Any areolar abnormalities that are deemed clinically significant by the Investigator

Study Design

Total Participants: 184
Study Start date:
July 01, 2020
Estimated Completion Date:
May 26, 2022

Study 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.

Connect with a study center

  • Private Clinic- David Kulber

    Los Angeles, California 90048
    United States

    Site Not Available

  • Pasadena Surgeons

    Pasadena, California 91105
    United States

    Site Not Available

  • Universal Axon Clinical Research

    Doral, Florida 33166
    United States

    Site Not Available

  • University of Florida Health

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Miami Plastic Surgery

    Miami, Florida 33176
    United States

    Site Not Available

  • Ibrahim H. Amjad, MD, PA

    W. Miami, Florida 33144
    United States

    Site Not Available

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

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Iowa Plastic Surgery

    Davenport, Iowa 52807
    United States

    Site Not Available

  • Washington University School of Medicine/Barnes-Jewish Hospital

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Luxurgery

    New York, New York 10021
    United States

    Site Not Available

  • Wake Forest Baptist Hospital - Plastic and Reconstructive Surgery

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Paul Glat, MD PC

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • Integrated Aesthetics

    Spring, Texas 77388
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Washingtonian Plastic Surgery

    McLean, Virginia 22102
    United States

    Site Not Available

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