A Phase II, Closed Label, Randomized, Double Blind Study for the Treatment of Acute Induced Wounds With TolaSure Gel, 5% w/w in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Accelerated Wound Closure
研究概览
简要总结
TolaSure is a topical gel for the promotion of accelerated wound healing. This phase II study will primarily assess the efficacy of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. Safety, cutaneous tolerability, wound pain control, and quality of healing will also be assessed. A total of 80 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will be monitored for safety and efficacy until wound closure (estimation about 8 weeks) following topical administration of TolaSure.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Males and Females > 18 years of age
- •Health history review
- •Physical exam
- •Blood and urine clinical chemistries
- •Negative pregnancy test
排除标准
- •Acute or chronic skin disorders (e.g. psoriasis);
- •Acne or dermatitis at the test site;
- •Prone to keloids or hypertrophic scarring;
- •Topical or systemic antibiotics within 4 weeks of study enrollment;
- •Subjects with known severe mental illness which, in the investigator's opinion, may prevent informed consent or interfere with the subject's ability to comply with study protocol procedures;
- •Diagnosed with Diabetes Type I/II or glucose results indicative of prediabetic condition;
- •Morbidly obese with a Body Mass Index (BMI) ≥ 40;
- •Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
- •History of severe vitamin or mineral deficiency;
- •History of drug or alcohol abuse (as defined by the Investigator);
- •Smoking/Vaping;
- •HIV/AIDS;
- •Consistently taking steroids and/or non-steroidal anti-inflammatory drugs. Subjects may use NSAIDs on an as needed basis with no more than 7 days of consecutive use;
- •Cancer diagnosis in the last 5 years;
- •Currently receiving chemotherapy or radiation;
- •Women who are pregnant, nursing, or planning a pregnancy;
- •Hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields;
- •Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study;
- •Treatment with any investigational agent within one month before treatment application for this trial;
- •Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule;
- •Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
研究组 & 干预措施
5 Percent TolaSure Topical Gel
5%(w/w) TolaSure Gel
干预措施: TolaSure Topical Gel (Drug)
Topical Vehicle Gel
Vehicle Gel
干预措施: Topical Vehicle Gel (Drug)
结局指标
主要结局
Accelerated Wound Closure
时间窗: Day 1, 2, and 7, then weekly until closure (estimated 8 weeks)
Time-to-closure will be calculated by the number of days from biopsy to wound closure. Wound closure (changes in wound area (mm\^2) over time) will be determined by the digital imaging platform software with Principal Investigator confirmation.
次要结局
- Percent Area Reduction after Four Weeks(Week 4)
- Wound Pain Control(Day 2 and 7, then weekly until wound closure (estimated 8 weeks))
- Quality of Healing(End of study (estimated 8 weeks))
- Cutaneous Tolerability(Day 1, 2, and 7, then weekly until wound closure (estimated 8 weeks))
- Blood and Urine Chemistries(Screening, Day 2 and 7, then weekly until wound closure (estimated 8 weeks))