A Phase One, Single Center, Open-Label, University of Miami Medical Center, 14 Day Study Evaluating the Safety, Cutaneous Tolerability, and Efficacy of TolaSure Topical Gel in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Blood and Urine Chemistries
研究概览
简要总结
TolaSure is a topical gel for the promotion of wound healing. This phase I study will assess the safety, tolerability and clinical effect of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. A total of 26 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will monitored for safety and efficacy over the course of 2 weeks following daily topical administration of TolaSure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes Assessor is blinded to treatment groups and vehicle control.
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
- •Pregnancy test
- •Drug screen
排除标准
- •Acute or chronic skin disorders (e.g. acne, psoriasis, dermatitis)
- •Prone to keloids or hypertrophic scarring
- •Topical or systemic antibiotics within 4 weeks of study enrollment
- •Subjects with mental illnesses
- •Diagnosed with Diabetes Type I/II
- •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
- •Consistently taking steroids and/or non-steroidal anti-inflammatory drugs
- •Cancer diagnosis in the last year
- •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
干预措施: TolaSure Topical Gel (Drug)
1.5 Percent TolaSure Topical Gel
干预措施: TolaSure Topical Gel (Drug)
0.5 Percent TolaSure Topical Gel
干预措施: TolaSure Topical Gel (Drug)
Topical Vehicle Gel
干预措施: TolaSure Topical Gel (Drug)
结局指标
主要结局
Blood and Urine Chemistries
时间窗: Day 1, 2, 7 and 14.
Absolute values and changes over time of clinical chemistries including; Absolute values and changes over time of clinical blood and urine chemistries including; Hematology and Coagulation, Coagulation, Serum Chemistry, and Urinalysis. Blood and urine analytes are measured on a per mL basis.
Cutaneous Tolerability
时间窗: Day 1, 2, 7 and 14.
Cutaneous tolerability will include an evaluation of erythema and edema following the modified Draize scoring system. Draize scores will be recorded and changes from baseline Draize scores will be monitored over the course of the time frame. Draize Scoring System. Erythema: 0-No Erythema, 1-Slight Erythema, 2-Well Defined Erythema, 3- Moderate or Severe Erythema, 4- Severe Erythema or slight eschar formation. Edema: 0- No Edema, 1- Very Slight Edema(barely perceptible), 2-Slight Edema (well defined edges), 3-Moderate Edema (raised \>1mm), 4- Severe Edema (raised \>1mm and extending beyond the area of exposure)
次要结局
- Wound Closure(Day 1, 2, 7 and 14.)