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

NCT04331080 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 2019-SCAR-01
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Mammoplasty; Scarring; Scar; Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in scar severity at Month 6, Month 9 and Month 12

  Month 6, Month 9 and Month 12

• Change in scar severity at Month 9

  Month 9

• Proportion of subjects with incision healing complications

  Day 1 to Month 12

• Proportion of subjects with incision infection

  Day 1 to Month 12

Study Arms (3)

Granexin® gel 100 μM

EXPERIMENTAL

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; Drug: Vehicle gel

Granexin® gel 200 μM

EXPERIMENTAL

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: Granexin® gel 200 μM; Drug: Vehicle gel

Vehicle Gel

PLACEBO COMPARATOR

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; Drug: Granexin® gel 200 μM; Drug: Vehicle gel

Interventions

Granexin® gel 100 μM DRUG

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

Granexin® gel 100 μM; Vehicle Gel

Granexin® gel 200 μM DRUG

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

Granexin® gel 200 μM; Vehicle Gel

Vehicle gel DRUG

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

Also known as: placebo

Granexin® gel 100 μM; Granexin® gel 200 μM; Vehicle Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects aged 18 years and older
• Female subjects of childbearing potential must have a negative urine or blood pregnancy test at screening and baseline.
• 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
• Subjects undergoing a breast surgery procedure with bilateral anchor incisions
• Signed informed consent form

You may not qualify if:

• Subjects with breast implants or history of breast implants
• Subjects undergoing breast surgery requiring breast implants
• Subjects requiring nipple grafting using any technique
• Subjects with a history of infection in the past 6 months in the intended area of incision
• Subjects with breast tattoos in the intended area of the incision
• Subjects with known skin sensitivity to Tegaderm™
• Subjects with a history of keloids
• Known conditions of collagen vascular diseases
• 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:
• Renal insufficiency as an estimated GFR, which is \< 30 mL/min/1.7m2
• Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range
• Hepatic insufficiency defined as total bilirubin \> 2 mg/dL or serum albumin \< 25 g/L
• Hemoglobin \< 9 g/dL
• Hematocrit \< 30%
• Platelet count \< 100,000 μL

Sponsors & Collaborators

• Xequel Bio, Inc.: lead

Study Sites (11)

Private Clinic- David Kulber

Los Angeles, California, 90048, United States

Location

Pasadena Surgeons

Pasadena, California, 91105, United States

Location

Universal Axon Clinical Research

Doral, Florida, 33166, United States

Location

Miami Plastic Surgery

Miami, Florida, 33176, United States

Location

Ibrahim H. Amjad, MD, PA

West Miami, Florida, 33144, United States

Location

Northwestern University - Feinberg School of Medicine - Division of Plastic & Reconstructive Surgery

Chicago, Illinois, 60611, United States

Location

Iowa Plastic Surgery

Davenport, Iowa, 52807, United States

Location

Luxurgery

New York, New York, 10021, United States

Location

Wake Forest Baptist Hospital - Plastic and Reconstructive Surgery

Winston-Salem, North Carolina, 27157, United States

Location

Integrated Aesthetics

Spring, Texas, 77388, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: July 1, 2020
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)