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

Phase 2

Completed

• Conditions: Scarring; Mammoplasty; Scar; Breast Reconstruction
• Interventions: Drug: Granexin® gel 100 μM; Drug: Granexin® gel 200 μM; Drug: Vehicle gel

• Registration Number: NCT04331080
• Lead Sponsor: Xequel Bio, Inc.

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.

Study Timeline

• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-02
• Study Start: 2020-07-01
• Primary Completion: 2022-05-26
• Study Completion: 2022-05-26
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Granexin® gel 100 μM	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.
Granexin® gel 100 μM	Vehicle gel	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.
Granexin® gel 200 μM	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.
Granexin® gel 200 μM	Vehicle gel	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.
Vehicle Gel	Granexin® gel 100 μM	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.
Vehicle Gel	Granexin® gel 200 μM	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.
Vehicle Gel	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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.
Proportion of subjects with incision healing complications	Day 1 to Month 12	Investigator's assessment of incision healing complications
Proportion of subjects with incision infection	Day 1 to Month 12	Investigator's assessment of presence or absence of infection

Trial Locations

Locations (11)

Private Clinic- David Kulber; 🇺🇸 Los Angeles, California, United States

Miami Plastic Surgery; 🇺🇸 Miami, Florida, United States

Integrated Aesthetics; 🇺🇸 Spring, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Universal Axon Clinical Research; 🇺🇸 Doral, Florida, United States

Pasadena Surgeons; 🇺🇸 Pasadena, California, United States

Ibrahim H. Amjad, MD, PA; 🇺🇸 W. 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