Double-blind, Randomized, Placebo-controlled Phase 2 Pilot Study to Investigate the Safety and Clinical Outcomes of 1.0 % Topically Applied GLYC-101, Compared to Placebo, in Healthy Subjects Undergoing Retro-auricular Carbon Dioxide Laser Skin Resurfacing.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Time to Complete Wound Closure (Epithelialization)
研究概览
简要总结
Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.
详细描述
The proposed pilot-study will document feasibility, safety and efficacy of topically applied Glucoprime gel (GLYC-101 gel 1.0 %) in promoting wound healing in healthy volunteer subjects undergoing retro-auricular Carbon Dioxide Laser Skin Resurfacing (CO2 LSR). The study will observe the effects of the topical agent over the course of 1 month following the treatment. as a preparation for study GLYC-101-1b (Double-blind, randomized, placebo-controlled Phase 2 Pilot Study to investigate the safety and efficacy of 1.0 % topically applied GLYC 101 compared to placebo, in patients undergoing Carbon Dioxide Laser Skin Resurfacing).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects meeting all of the following criteria will be considered for admission to the study:
- •Patients giving informed consent for retro-auricular laser ablation between 25 and 55 years old.
- •Retro-auricular area is free of any irritation, scars 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.
排除标准
- •Pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
- •Systemic or cutaneous disease that may interfere with the study results.
- •Presence of irritation or dermatologic skin conditions in the retro-auricular area.
- •Known allergies to materials within the test formulations.
- •Systemic or cutaneous therapy with medication that impacts wound healing (steroids, immune modulators, immune suppressants).
研究组 & 干预措施
1
GLYC-101 Active Retro-auricular Site (1 per participant)
干预措施: GLYC-101 gel (1.0 %) (Drug)
2 Comparator
Placebo Retro-auricular Site (1 per participant)
This arm undergoes laser ablation with subsequent Placebo gel administration
干预措施: Placebo gel (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 every 2 days from the time of the laser procedures for the first 10 days and then seen every 2 weeks for 4 weeks. 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
- Percentage of Wound Epithelialized(Day 15 post laser ablation.)