Double Blind, Single-Center, Randomized, Within Subject Placebo, Phase I Study Evaluating the Effects of Novel Topical Gel in Prevention of Hypertrophic Scar Formation
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Serious Adverse Events
研究概览
简要总结
Researchers are trying to find out more about the side effects of topical (applied to the skin) Pentamidine, to determine if it is safe for use in people. They also want to find out if topical use of Pentamidine can help treat hypertrophic scars.
Pentamidine is a medicine that is currently used to treat certain kinds of infection. It is most often given by intravenous (into a vein) or inhalation (through a breathing device). This medication is approved by the U.S. Food and Drug Administration (FDA) for use in these forms.
Everyone in this study will receive topical Pentamidine (TP) in a silicone based gel (PCCA Pracasil Plus). Topical treatment of Pentamidine is still experimental and has not been formally tested for safety or effectiveness in a randomized control trial within the United States. The FDA has allowed the use of topical Pentamidine in this research study.
详细描述
This study will investigate Pentamidine isethionate, compounded in a silicone-containing base, as adjuvant therapy to surgical scar excision to prevent adverse scarring and enhance skin rejuvenation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization will done by the Research Pharmacy
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hypertrophic scar by a Mayo Clinic plastic surgeon or dermatologist.
- •Target disease or condition: Hypertrophic scar
- •Subject with a hypertrophic scar that meet all of the following criteria:
- •Linear scar ≥5 to ≤40 cm in length
- •Present for minimum 6 months
- •Located anywhere in the body except on the face or front of neck
- •Resulting from surgical or traumatic injury, or other scar considered appropriate for surgical excision
- •Ability to safely undergo scar excision surgery
- •Capacity to provide informed consent
- •Ability to comply with protocol
- •Subject is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, electrocardiogram, vital signs, and clinical laboratory tests.
排除标准
- •Subjects identified as having a keloid or a scar not appropriate for surgical excision
- •Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody and HIV as determined in screening the subject's electronic medical record.
- •Concurrent use of corticosteroids (including inhaled steroids), cyclooxygenase-2 (COX-2) inhibitors and/or drugs that are strong inhibitors and inducers of cytochrome P450 (CYP) enzymes
- •Are immuno-compromised (HIV infected, cancer and other disease affecting the basal immune response)
- •Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the investigator, not stabilized or may otherwise impact the results of the study.
- •Subjects with renal and hepatic impairment.
- •Known allergy or hypersensitivity to the study drug(s) or one of the ingredients of the formulation.
- •Any infection or wound in the area to treat including photosensitive dermatosis or inflammatory acne.
- •Existence of any surgical, medical or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug
- •Participation in another clinical study in the past 30 days or concurrent participation in another clinical trial.
- •Patients with poorly controlled diabetes mellitus (HbA1C ≥ 8%), peripheral neuropathy, or known concomitant vascular problems.
- •Pregnant or lactating female patients.
- •Prisoners.
- •Subjects who smoke cigarettes and/or use other tobacco products.
研究组 & 干预措施
Topical Pentamidine Isethionate
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
干预措施: Pentamidine Isethionate (Drug)
Placebo Control
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
干预措施: Placebo (Drug)
结局指标
主要结局
Serious Adverse Events
时间窗: 4 weeks post-operatively
Number of participants to experience serious adverse events as defined as death \[due to treatment\] or life threatening adverse experience \[due to treatment\], hospitalization \[due to treatment\], persistent or significant disability or incapacity \[due to treatment\], birth defect/anomalies \[due to treatment\] and tissue necrosis \[due to treatment\].
次要结局
- Vancouver Scar Scale (VSS)(Baseline (preoperatively) and at weeks 2 and 4.)
- Adverse Events(4 weeks post-operatively)
- Change in Scar Fibrosis(Baseline (preoperatively) and 4 weeks post-operatively.)
- Change in Scar Sclerosis(Baseline (preoperatively) and 4 weeks post-operatively.)
- Change in Scar Volume(Baseline (pre-operatively) and at postop week 2 and 4.)
- Change in Scar Angioplasia(Baseline (preoperatively) and 4 weeks post-operatively.)
- Change in Scar Relative Depth(Baseline (preoperatively) and 4 weeks post-operatively)
- Change in Scar Absolute Depth(Baseline (preoperatively) and 4 weeks post-operatively)
- Patient Scar Assessment Scale (PSAS)(Baseline (preoperatively) and at weeks 2 and 4.)
- Observer Scar Assessment Scale (OSAS)(Baseline (preoperatively), 2 weeks, and 4 weeks)
研究者
Alexander Meves
Principal Investigator
Mayo Clinic