A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Injections in Facial Scar Reduction After Undergoing Mohs Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bonti, Inc.
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best))
研究概览
简要总结
This study will evaluate the safety and efficacy of EB-001 in improving wound healing and reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead area following a single treatment of EB-001 when injected into the muscles underlying the incision area.
详细描述
This study will evaluate the safety and efficacy of EB-001 in improving wound healing and reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead area following a single treatment of EB-001 when injected into the muscles underlying the incision area.
The safety objective is to determine the safety and tolerability of single treatment of EB-001 when injected into facial muscles underlying a surgical wound during Mohs surgery.
The efficacy objective is to evaluate the efficacy of a single treatment of EB-001 when injected into the facial muscles (frontalis) underlying the surgical wound in improving wound healing, and reducing scar formation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 75 years of age, inclusive
- •Subject in good health, or with stable treated medical condition, as determined by the investigator.
- •Scheduled to undergo Mohs surgery to remove a single skin lesion in the forehead. This could be
- •Basal Cell Carcinoma
- •Squamous Cell Carcinoma (non-metastatic)
- •Other suitable lesions according to the investigator opinion
- •Lesion closure size at least 2 cm in length
- •Women of non-childbearing potential must be postmenopausal (at least 12 consecutive months of amenorrhea)
- •Women of childbearing potential must not be pregnant, lactating, or planning to become pregnant during the study
- •Women of childbearing potential agreeing to use either
- •a highly effective method of contraception with failures rates less than 1% per year such as implant, intrauterine device (IUD), or sterilization from the day of dosing for 3 months (subjects who underwent sterilization must have initiated the procedure at least 3 months prior to the day of dosing) or
- •dual methods of contraception with overall failures rates less than 1% per year such as injectable, pill, patch, ring, and diaphragm from the day of dosing for 3 months (subjects using oral contraception must have initiated treatment at least 2 months prior to the day of dosing)
- •Willing and able to complete and comply with procedures, protocol requirements and instructions, which includes completion of all required visits
- •Willing and able to sign and date IRB-approved informed consent
- •Able to speak, read, and understand the language of the informed consent form (ICF) and study questionnaires
排除标准
- •Pregnant or breast feeding, or planning a pregnancy
- •Body weight less than 50 kg (110 pounds)
- •Reported use of any botulinum toxin of any serotype within last 6 months before study drug administration
- •Anticipated use of any botulinum toxin of any serotype during the study
- •Known hypersensitivity to any botulinum toxin serotype
- •Known allergy or sensitivity to any of the components of the study treatments, or any materials used in the study procedures
- •Aminoglycoside intake within 48 hours prior to or during surgery
- •Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral Sclerosis)
- •Any uncontrolled medical condition that in opinion of investigator, puts subject at undue safety risk
- •Any clinically significant psychiatric condition that, in opinion of investigator, may interfere with study assessments or protocol compliance
- •Any cosmetic procedure, laser resurfacing treatment, or retinoid therapy in the forehead area in the past 30 days before study drug administration
- •Any eyebrow or eyelid ptosis at baseline as determined by the Investigator
- •History of hypertrophic scars or keloid formation or other wound abnormalities as assessed by the investigator
- •History of alcohol or drug abuse in the last 3 years, based on investigator judgement
- •User or former user of nicotine-containing products, as follows:
- •including but not limited to cigarettes, cigars, and chewing or dipping tobacco) who stopped use or consumption (i.e., smoking, chewing, or pinching) of these nicotine-containing products less than 1 year before study drug administration, or
- •topical or oral nicotine preparations for smoking cessation within the past 90 days before study drug administration
- •Anticipated need for surgery or overnight hospitalization during the study
- •Current enrollment in an investigational drug or device study or participation in such a study within 30 days or 5 half-lives of the drug, whichever is longer, of entry into this study
研究组 & 干预措施
Placebo
Drug: : Placebo: 0.9% Sodium Chloride Injection
Injection of Placebo into area of scarring (forehead)
干预措施: 0.9% Sodium Chloride Injection (Drug)
EB001
Drug: EB-001 Injection of EB-001 into area of scarring (forehead)
干预措施: EB-001 (Drug)
结局指标
主要结局
Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best))
时间窗: Day 30
Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 30. Percentage of subjects reporting an improvement in Visual Analog Scale score.
次要结局
未报告次要终点