Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Investigate the Safety and Efficacy of 0.1% and 1.0% Topically Applied GLYC-101, Compared to Placebo, in Patients Undergoing Carbon Dioxide Laser Skin Resurfacing of the Lower Eyelids.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Time to Complete Wound Closure (Epithelialization)
研究概览
简要总结
The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. The study will observe the effects of the topical agent over the course of 1 month following the initial treatment.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female healthy volunteer subjects, between 25 and 70 years of age, giving informed consent for facial laser ablation of the lower eyelid areas for the purpose of wrinkle removal.
- •Lower eyelid skin is free of any irritation, scarring or dermatologic conditions which might interfere with the study.
- •Willing and able to participate in the study and follow all study directions.
- •Able to read, understand and sign the consent form prior to any study related procedures.
排除标准
- •Female subjects who are pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
- •Presence of irritation or dermatologic skin conditions in the lower eyelid area.
- •Known allergies to materials within the test formulations (i.e., yeast and/or yeast products).
- •Use of topical or systemic drugs (corticosteroids, retinoids, immune modulators, immune suppressants, drugs with potential for contact dermatitis, drugs with potential for skin discoloration) that may have an effect on wound healing or may impact skin pigmentation.
- •A history, upon wounding, of developing thickened scars, keloids, or excessive pigment change.
- •An unstable or severe inter-current medical condition that, in the opinion of the investigator, might interfere with interpretation of study results or render the subject at high risk for treatment complications.
- •Use of any investigational medication or device for any indication within 30 days of screening.
研究组 & 干预措施
1
GLYC-101 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid
干预措施: GLYC-101 Gel (0.1%) (Drug)
1
GLYC-101 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid
干预措施: GLYC-101 Placebo (Drug)
2
GLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid
干预措施: GLYC-101 Gel (1.0%) (Drug)
2
GLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid
干预措施: GLYC-101 Placebo (Drug)
3
GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid
干预措施: GLYC-101 Gel (0.1%) (Drug)
3
GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid
干预措施: GLYC-101 Gel (1.0%) (Drug)
结局指标
主要结局
Time to Complete Wound Closure (Epithelialization)
时间窗: Over the course of 1 month following the initial treatment.
Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject's wounds reached 100% epithelialization. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.
次要结局
- Cosmesis/11-point Likert Scale(At 1 month following the initial treatment.)