Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)
研究概览
简要总结
Follicular donor sites on the scalp for hair transplantation will be treated with studied products post harvest.
A randomized side of the scalp will be treated with Stratamed, the other side with standard clinical practice.
Subjects will be assessed live immediately post treatment and in 2 sessions during the healing phase post harvest. Subjects will also complete subject reported outcome questionnaires at home between study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is an randomized, single-blind, split-scalp study, such that subjects will know what side of the scalp the investigational and standard treatment products are applied. The PI will evaluate efficacy and safety blinded.
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
- •Over 18 years old
- •Able to provide informed consent
- •Planning to undergo follicular unit extraction hair restoration
排除标准
- •Significant medical or surgical conditions
- •Unable to give informed consent
- •Patient unable to apply topical device
- •Allergy or intolerance to ingredients or excipients of the formulation of studied products
- •Pregnancy
研究组 & 干预措施
Treatment left
A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.
干预措施: Treatment - Stratamed (Device)
Treatment right
A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.
干预措施: Treatment - Stratamed (Device)
结局指标
主要结局
Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)
时间窗: duration of the studybe evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the investigational and standard treatment products
Stratamed will improve the healing response vs. current standard of care therapy. Healing Response (4 point ordinal scale) LEFT SIDE * Not healed at all (0%) * Mildly healed (33%) * Moderately healed (66%) * Completely healed (100%) RIGHT SIDE * Not healed at all (0%) * Mild healing (33%) * Moderately healed (66%) * Completely healed (100%)
次要结局
未报告次要终点