NCT00713349已完成2 期
A Randomized, Evaluator Blinded, Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing of Induced Thermal Wounds
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Healthpoint
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Complete Wound Closure
研究概览
简要总结
The objective of the study is to compare the healing of wounds induced by cryo-injury when treated with white petrolatum versus an ointment vehicle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 will be considered qualified for enrollment if they:
- •Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks and contact information.
- •Are male or female, ≥ 18 years of age, of any race.
- •Are willing to attend all required study visits, and to comply with study procedures.
- •Meet none of the exclusion criteria (any single exclusion criterion which is met by a potential subject will disqualify that subject from participation in this study).
排除标准
- •Subjects will be considered NOT qualified for enrollment if they:
- •Have a history of dermatomyositis, systemic sclerosis, scleroderma, Sjögren's syndrome, systemic lupus erythematosis, discoid lupus, Ehler's Danlos disease, icthyosis vulgaris, vasculitis or bleeding disorders (coagulopathies).
- •Have any dermatologic disease which may be aggravated or provoked by the wounding procedure, such as Lichen Planus, Psoriasis or Vitiligo.
- •Have Fitzpatrick scale skin type 6 (never sunburns, deeply pigmented).
- •Are at risk of keloid or hypertrophic scar formation, based on personal history, family history, or brief skin exam (conducted at the screening visit to look for keloids or hypertrophic scars).
- •Have been treated within the last three months for uncontrolled diabetes mellitus, peripheral vascular disease, vitamin C deficiency, connective tissue disorders, or any other disease process that impedes wound healing.
- •Are taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs.
- •Are using topical glycolic acid products, alpha-hydroxy acid products, retinoids or chemical peel agents in the treatment areas.
- •Are using systemic steroids or immunosuppressant agents, or have used these drugs within the past three months.
研究组 & 干预措施
2
Placebo Comparator
Placebo Comparator
干预措施: Placebo comparator (Other)
1
Other
Xenaderm Vehicle
干预措施: Xenaderm Vehicle (Drug)
结局指标
主要结局
Complete Wound Closure
时间窗: 21 Days
Each subject acting as their own control
次要结局
未报告次要终点
研究者
研究点 (1)
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