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

NCT ID: NCT04331080

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-05-26

Brief 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.

Conditions

Mammoplasty; Scarring; Scar; Breast Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Granexin® gel 100 μM

Intervention Type: DRUG

Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

Vehicle gel

Intervention Type: DRUG

Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

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.

Group Type: EXPERIMENTAL

Granexin® gel 200 μM

Intervention Type: DRUG

Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

Vehicle gel

Intervention Type: DRUG

Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

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.

Group Type: PLACEBO_COMPARATOR

Granexin® gel 100 μM

Intervention Type: DRUG

Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

Granexin® gel 200 μM

Intervention Type: DRUG

Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

Vehicle gel

Intervention Type: DRUG

Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

Interventions

Granexin® gel 100 μM

Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

Intervention Type: DRUG

Granexin® gel 200 μM

Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

Intervention Type: DRUG

Vehicle gel

Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

Intervention Type: DRUG

Other Intervention Names

placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xequel Bio, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

2019-SCAR-01

Identifier Type: -

Identifier Source: org_study_id