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The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granexin® gel 100 μM | Drug | Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in scar severity at Month 9 |
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Inclusion Criteria:
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:
Non-childbearing confirmed by prior documentation of at least one of the following:
Subjects undergoing a breast surgery procedure with bilateral anchor incisions
Signed informed consent form
Exclusion Criteria:
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:
Any history within the last 5 years or the presence of any active systemic cancer (with the exception of non-melanoma skin cancer)
Current treatment with systemic corticosteroids (>15 mg/day). Washout period is 30 days prior to screening
Current treatment with biologic immunosuppressive agents or chemotherapeutic agents. Wash out period for short term immunosuppressive agents is 14 days prior to screening
Previous history of radiation therapy to the chest
Known inability to complete required study visits during study participation
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
Use of any investigational drug or therapy within the 28 days prior to screening
History of previous breast surgeries in the area where the incisions are to be made
Currently pregnant, pregnant during the 6 months prior to screening, lactating, or breastfeeding
Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in the study
Any areolar abnormalities that are deemed clinically significant by the Investigator
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Clinic- David Kulber | Los Angeles | California | 90048 | United States | ||
| Pasadena Surgeons |
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| Granexin® gel 200 μM | Drug | Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery. |
|
| Vehicle gel | Drug | Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery. |
|
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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 |
| Proportion of subjects with incision healing complications | Investigator's assessment of incision healing complications | Day 1 to Month 12 |
| Proportion of subjects with incision infection | Investigator's assessment of presence or absence of infection | Day 1 to Month 12 |
| Pasadena |
| California |
| 91105 |
| United States |
| Universal Axon Clinical Research | Doral | Florida | 33166 | United States |
| Miami Plastic Surgery | Miami | Florida | 33176 | United States |
| Ibrahim H. Amjad, MD, PA | West Miami | Florida | 33144 | United States |
| Northwestern University - Feinberg School of Medicine - Division of Plastic & Reconstructive Surgery | Chicago | Illinois | 60611 | United States |
| Iowa Plastic Surgery | Davenport | Iowa | 52807 | United States |
| Luxurgery | New York | New York | 10021 | United States |
| Wake Forest Baptist Hospital - Plastic and Reconstructive Surgery | Winston-Salem | North Carolina | 27157 | United States |
| Integrated Aesthetics | Spring | Texas | 77388 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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