Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- VSS total scores at Day 1 and Week 12 assessed by 3 blind evaluators
研究概览
简要总结
The aim of this study is to evaluate the efficacy of the Fespixon cream for prevention and/or appearance reduction of different types of linear scars during the 12-week treatment phase, which is assessed by the blinded independent evaluator.
详细描述
Methods: This study was designed as a prospective, double-blind, placebo-controlled trial involving 50 patients with linear scars. Bounded by the midpoint of the scar, each patient received a topical scar formulation consisting of fespixon cream on one side of scar, and placebo cream on the other side of scar. Treatment was given twice a day for 84 days. Assessments of the scars were performed at visit 1, 2, 3 following the onset of topical application using three methods: a clinical assessment using the Vancouver Scar Scale/ modified Vancouver Scar Scale, a photographic assessment to establish before and after treatment improvements, and at the end of the study period, patients completed a final satisfaction questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcomes (VSS score) assessors do not know which side is applied with the therapeutic ointment.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged over 20 years old (inclusive).
- •Subjects with linear scar in neck or abdomen following elective surgery, including thyroid and parathyroid surgery, excision of neck mass, caesarean section, trans-abdominal hysterectomy, trans-abdominal myomectomy or any neck or abdominal surgeries which can be managed by primary closure of clean surgical wounds.
排除标准
- •Subjects who have previous neck or abdominal trauma that will affect the surgical incision site.
- •After radiation therapy for cervical/abdominal cancer, or previous medical history with chemo-therapy or targeted therapy for any reason.
- •Laboratory values at Screening of:
- •Note: The investigator will decide which of the following laboratory tests should be performed considering the condition of the subject.
- •Albumin < 2.5 g/dL (for subjects with severe malnutrition)
- •HbA1c >12.0% (for subjects with severe diabetes)
- •Liver function test [ aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal
- •Renal function test [Serum Creatinine] > 2x the upper limit of normal
- •Subject is currently receiving immunosuppressant or systemic corticosteroids.
- •Has any other factor which may, in the opinion of the investigator, compromise participation in the study.(Including subjects with medical history of keloid or hypertrophic scar).
研究组 & 干预措施
Fespixon cream
Fespixon cream contains 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) with appearance in yellow-green to light green color. Fespixon cream will be applied twice daily for up to 12 weeks to the linear wound.
干预措施: Fespixon cream (Drug)
Placebo Cream
Placebo cream with appearance in yellow-green to light green color, same appearance as Fespixon cream, will be applied twice daily for up to 12 weeks to the linear wound.
干预措施: Placebo Cream (Drug)
结局指标
主要结局
VSS total scores at Day 1 and Week 12 assessed by 3 blind evaluators
时间窗: 12-week
The VSS scores, assessed by 3 blind evaluators, changed from Day 1 to Week 12 will be used as an objective evidence.
次要结局
- mVSS individual scores at Day 1 and Week 12 assessed by a Principal Investigator(12-week)
- Hue feature-Red values via digital analysis at Day 1 and Week 12(12-week)
- Hue feature-Green values via digital analysis at Day 1 and Week 12(12-week)
- Hue feature-Blue values via digital analysis at Day 1 and Week 12(12-week)
- CIELab-lightness values via digital analysis at Day 1 and Week 12(12-week)
- CIELab-a values via digital analysis at Day 1 and Week 12(12-week)
- CIELab-b values via digital analysis at Day 1 and Week 12(12-week)
- Textual features-Contrast (Con) values via digital analysis at Day 1 and Week 12(12-week)
- Textual features-Homogeneity (Hom) values via digital analysis at Day 1 and Week 12(12-week)
- Textual features-Correlation (Cor) values via digital analysis at Day 1 and Week 12(12-week)
- VAS (Visual Analogue Scale) score at Week 12(12-week)
- Textual features-Entropy (ENT) values via digital analysis at Day 1 and Week 12(12-week)
研究者
Shao-Cheng Liu
Associate Professor
National Defense Medical Center, Taiwan