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

Sponsor
Xequel Bio, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT04331080
Collaborator
(none)
184
Enrollment
11
Locations
3
Arms
22.8
Actual Duration (Months)
16.7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Granexin® gel 100 μM
  • Drug: Granexin® gel 200 μM
  • Drug: Vehicle gel
 Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
184 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 1, 2020
Actual Primary Completion Date :
May 26, 2022
Actual Study Completion Date :
May 26, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Granexin® gel 100 μM

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.

Drug: Granexin® gel 100 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.
Other Names:
  • placebo

    		•
    Experimental: Granexin® gel 200 μM

    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.

    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.
    Other Names:
  • placebo

    		•
    Placebo Comparator: Vehicle Gel

    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.

    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.
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in scar severity at Month 12 [Month 12]

      Assessed using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS has a rage from 6 to 60 with higher scores indicating worse outcomes. One scale will be used for each segment of the scar. The score from each segment will be combined into one score.

    Secondary Outcome Measures

    1. Change in scar severity at Month 6, Month 9 and Month 12 [Month 6, Month 9 and Month 12]

      Assessed using the Scar Cosmesis Assessment and Rating (SCAR) Scale. The SCAR scale has a range of 0 (best possible scar) to 15 (worst possible scar).

    2. Change in scar severity at Month 9 [Month 9]

      Assessed using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS has a range from 6 to 60 with higher scores indicating worse outcomes. One scale will be used for each segment of the scar. The score from each segment will be combined into one score.

    3. Proportion of subjects with incision healing complications [Day 1 to Month 12]

      Investigator's assessment of incision healing complications

    4. Proportion of subjects with incision infection [Day 1 to Month 12]

      Investigator's assessment of presence or absence of infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    • surgically sterilized

    1. Subjects undergoing a breast surgery procedure with bilateral anchor incisions

    2. Signed informed consent form

    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:

    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 the normal range

    12. Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/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 30 days 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, 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

    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, or breastfeeding

    25. Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in the study

    26. Any areolar abnormalities that are deemed clinically significant by the Investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Private Clinic- David Kulber Los Angeles California United States 90048
    2 Pasadena Surgeons Pasadena California United States 91105
    3 Universal Axon Clinical Research Doral Florida United States 33166
    4 Miami Plastic Surgery Miami Florida United States 33176
    5 Ibrahim H. Amjad, MD, PA W. Miami Florida United States 33144
    6 Northwestern University - Feinberg School of Medicine - Division of Plastic & Reconstructive Surgery Chicago Illinois United States 60611
    7 Iowa Plastic Surgery Davenport Iowa United States 52807
    8 Luxurgery New York New York United States 10021
    9 Wake Forest Baptist Hospital - Plastic and Reconstructive Surgery Winston-Salem North Carolina United States 27157
    10 Integrated Aesthetics Spring Texas United States 77388
    11 University of Utah Salt Lake City Utah United States 84132

    Sponsors and Collaborators

    • Xequel Bio, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xequel Bio, Inc.
    ClinicalTrials.gov Identifier:
    NCT04331080
    Other Study ID Numbers:
    • 2019-SCAR-01
    First Posted:
    Apr 2, 2020
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Surgical Wound

    Study Results

    No Results Posted as of Jun 6, 2022