A Prospective, Randomized, Investigator-blinded, Placebo-controlled, Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Lesion Volume
研究概览
简要总结
Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy.
0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely used over-the-counter medications for the treatment of keloids and hypertrophic scars. However, their efficacy and safety have not been compared in a blinded, placebo-controlled, prospective fashion. This study is being undertaken to determine the efficacy and safety of HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and keloids.
This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication.
You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be assigned by chance and you will have two in three chances of receiving treatment with a study medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no active ingredients such as steroids, silicone, vitamin E, or onion extract.
详细描述
This study will last up to 16 weeks, with a total of 5 visits to the clinic (Baseline visit, Week 4, 8, 12, and 16 ), excluding the Screening Visit.
Screening Visit/Baseline Visit:
Patients will read and be explained the informed consent. Patients who agree to participate will sign the informed consent and a copy will be given to them. Medical history and exclusion/inclusion criteria will be reviewed; if a patient qualifies he/she will be assigned a randomization number for the treatment.
At the baseline visit, medical history and exclusion/inclusion criteria since the screening visit will be reviewed. Patients randomized to the HSE group will receive one tube and apply the first application to the keloid/hypertrophic scar during the baseline visit. Patients randomized to the OE group will be given a tube of OE gel and will apply the first application to the keloid/hypertrophic scar. Patients in the placebo group will be given a bottle of CEA lotion, the placebo medication, and will apply the first application to the keloid/hypertrophic scar. The medications will be given by the unblinded investigator and the blinded investigator will be evaluating the patients. Photographs of the patient's keloid/hypertrophic scar will be taken, and the keloid/hypertrophic scar will be measured/assessed according to Methods of Study Lesion Assessment (below). A urine pregnancy test will be obtained for all women of child-bearing potential.
Week 4, 8, 12, and 16 Visit:
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
- Single (Investigator)
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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •Male or female, at least 18 years old in good general health, that have a hypertrophic and keloid scar. The length of the scar should be between 1-4 cm. Individuals who are willing and able to follow the requirements for study participation
- •The investigator believes that the scar could benefit from the study medication.
排除标准
- •Subjects who meet any of the following criteria should be excluded from the study:
- •Individuals with target scar that is not amenable to the randomized treatment
- •Individuals who are planning pregnancy, or pregnant as determined by urine pregnancy test during the duration of the study, or breast-feeding an infant
- •Individuals with uncontrolled diabetes or autoimmune disorders
- •Individuals who have received scar treatment within one month of the first day of study treatment
- •Individuals who plan to receive scar treatment(s) other than study treatment during the trial
- •Individuals with a known sensitivity to any ingredients in the test products
- •Individuals with any skin conditions or taking any medications that may interfere with the study medication.
研究组 & 干预措施
Regimen A
0.5% hydrocortisone, silicone, vitamin E lotion
干预措施: 0.5% hydrocortisone, silicone, vitamin E lotion (Drug)
Regimen B
Onion extract gel
干预措施: Onion extract gel (Drug)
Regimen C
Cetearyl alcohol lotion
干预措施: Cetearyl alcohol lotion (Drug)
结局指标
主要结局
Change in Lesion Volume
时间窗: Assessed at Baseline visit (week 0) and week 16
Blinded investigator assessed the scar volume by using an alginate impression.
次要结局
- Change in Lesion Length(Assessed at Baseline visit (week 0) and week 16)
- Change in Lesion Induration(Assessed at Baseline visit (week 0) and week 16)
- Change in Lesion Cosmetic Appearance(Assessed at Baseline visit (week 0) and week 16)
- Change in Lesion Width(Assessed at Baseline visit (week 0) and week 16)
- Change in Lesion Erythema(Assessed at Baseline visit (week 0) and week 16)
- Change in Lesion Pigmentary Alteration(Assessed at Baseline visit (week 0) and week 16)
研究者
Robert S. Kirsner
Professor
University of Miami