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

Breast Reconstruction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331080
• Other study ID #: 2019-SCAR-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 1, 2020
• Est. completion date: May 26, 2022

Study information

• Verified date: June 2022
• Source: Xequel Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 26, 2022
• Est. primary completion date: May 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction
• Mammoplasty
• Scar
• Scarring
• Surgical Wound

Intervention

Drug:
• Granexin® gel 100 µM
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
• Granexin® gel 200 µM
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
• Vehicle gel
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Xequel Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Proportion of subjects with incision healing complications	Investigator's assessment of incision healing complications	Day 1 to Month 12
Secondary	Proportion of subjects with incision infection	Investigator's assessment of presence or absence of infection	Day 1 to Month 12