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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 11
- 主要终点
- Change in scar severity at Month 12
研究概览
简要总结
The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Granexin® gel 100 μM (Drug)
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.
干预措施: Vehicle gel (Drug)
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.
干预措施: Granexin® gel 200 μM (Drug)
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.
干预措施: Vehicle gel (Drug)
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.
干预措施: Granexin® gel 100 μM (Drug)
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.
干预措施: Granexin® gel 200 μM (Drug)
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.
干预措施: Vehicle gel (Drug)
结局指标
主要结局
Change in scar severity at Month 12
时间窗: 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.
次要结局
- 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)