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

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

Study Overview

• Status: Completed
• Conditions: Scar; Breast Reconstruction; Scarring; Mammoplasty
• Intervention / Treatment: Drug: Granexin® gel 100 μM; Drug: Vehicle gel; Drug: Granexin® gel 200 μM

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 Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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
4. Subjects undergoing a breast surgery procedure with bilateral anchor incisions
5. 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:

   1. Renal insufficiency as an estimated GFR, which is < 30 mL/min/1.7m2
   2. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range
   3. Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/L
   4. Hemoglobin < 9 g/dL
   5. Hematocrit < 30%
   6. Platelet count < 100,000 μL
10. Any history within the last 5 years or the presence of any active systemic cancer (with the exception of non-melanoma skin cancer)
11. Current treatment with systemic corticosteroids (>15 mg/day). Washout period is 30 days prior to screening
12. Current treatment with biologic immunosuppressive agents or chemotherapeutic agents. Wash out period for short term immunosuppressive agents is 14 days prior to screening
13. Previous history of radiation therapy to the chest
14. Known inability to complete required study visits during study participation
15. 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
16. Use of any investigational drug or therapy within the 28 days prior to screening
17. History of previous breast surgeries in the area where the incisions are to be made
18. Currently pregnant, pregnant during the 6 months prior to screening, lactating, or breastfeeding
19. Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in the study
20. Any areolar abnormalities that are deemed clinically significant by the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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: Vehicle gel; Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.; Other Names: placebo; Drug: Granexin® gel 200 μM; Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
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: Vehicle gel; Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.; Other Names: placebo; Drug: Granexin® gel 200 μM; Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scar severity at 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.	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scar severity at 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).	Month 6, Month 9 and Month 12
Change in scar severity at 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.	Month 9
Proportion of subjects with incision healing complications	Investigator's assessment of incision healing complications	Day 1 to Month 12
Proportion of subjects with incision infection	Investigator's assessment of presence or absence of infection	Day 1 to Month 12

Collaborators and Investigators

• Sponsor: Xequel Bio, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): May 26, 2022
• Study Completion (ACTUAL): May 26, 2022

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (ACTUAL): April 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 2019-SCAR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No