Clinical trial NCT04331080: A Study of Granexin® Gel for the Reduction of Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mammoplasty
Scarring
Scar
Breast Reconstruction
Lead sponsor: Xequel Bio, Inc.
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in scar severity at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Change in scar severity at Month 6, Month 9 and Month 12
timeFrame: Month 6, Month 9 and Month 12
measure: Change in scar severity at Month 9
timeFrame: Month 9
measure: Proportion of subjects with incision healing complications
timeFrame: Day 1 to Month 12
measure: Proportion of subjects with incision infection
timeFrame: Day 1 to Month 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Private Clinic- David Kulber
state: California
city: Pasadena
country: United States
facility: Pasadena Surgeons
state: California
city: Doral
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Plastic Surgery
state: Florida
city: W. Miami
country: United States
facility: Ibrahim H. Amjad, MD, PA
state: Florida
city: Chicago
country: United States
facility: Northwestern University - Feinberg School of Medicine - Division of Plastic & Reconstructive Surgery
state: Illinois
city: Davenport
country: United States
facility: Iowa Plastic Surgery
state: Iowa
city: New York
country: United States
facility: Luxurgery
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Hospital - Plastic and Reconstructive Surgery
state: North Carolina
city: Spring
country: United States
facility: Integrated Aesthetics
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: