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临床试验/NCT03760250
NCT03760250终止2 期

Open-label, Single-arm Pilot Study of the Effects of Topical 5% Imiquimod Cream on Preventing Keloid Recurrence After Surgical Keloidectomy

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2019年2月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
6
试验地点
1
主要终点
Keloid Recurrence

研究概览

简要总结

This is an open-label, single-arm, pilot study on the effects of topical imiquimod treatment in preventing keloid recurrence after surgical excision. Keloids are abnormal scars that form in certain genetically predisposed individuals following trauma to the skin. They can be physically disabling and cause social impairment. Many therapies have been proposed and trialed for the permanent removal of keloids, but they all have limited efficacy. Topical imiquimod therapy has been reported to decrease keloid recurrence following keloidectomy in human patients. Given all previous reports of adjuvant imiquimod therapy to keloidectomy initiated imiquimod therapy after keloidectomy, the investigators would like to test the efficacy of topical imiquimod pre-treatment in preventing keloid recurrence after surgical excision. Therefore, the investigators are initiating an open-label pilot study of 10 patients age 18 or greater with keloids on the trunk and extremities excluding the groin and hands and feet who present to the dermatology clinic for standard of care keloid excision. Key exclusion criteria include vulnerable populations, immunocompromised state, hypersensitivity to study drug components, and keloids outside of specified areas. The main study intervention will be 6 weeks of treatment with topical 5% imiquimod cream, starting 1 week prior to surgical excision.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or greater
  • Men and women who present clinically with keloids requesting excision
  • Any number of keloids
  • Keloid no larger than 5cm in diameter at the base
  • Clinical findings consistent with keloid formation
  • Location of keloid in low-risk areas - areas other than above the neck, hands, feet, or groin
  • Able and willing to give informed consent

排除标准

  • Age < 18
  • Hypersensitivity to Imiquimod or to any of the excipients (methylhydroxybenzoate, propylhydroxybenzoate, cetyl alcohol, and stearyl alcohol)
  • Involvement in a trial of another experimental intervention within 30 days
  • Life threatening disease
  • Use of immunosuppressive medications such as oral corticosteroids
  • Bleeding disorders
  • Not available for follow-up for 10 weeks
  • Pregnant, intention to become pregnant during treatment phase of trial, or breastfeeding

研究组 & 干预措施

Imiquimod

Experimental

5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision

干预措施: Imiquimod 5% cream (Drug)

结局指标

主要结局

Keloid Recurrence

时间窗: 12 weeks after surgical excision

To assess the efficacy of 5% Imiquimod cream on decreasing keloid recurrence after excision when initiated prior to excision

次要结局

  • Tolerability - Local Site Reaction Rated on a Scale(12 weeks after surgical excision)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Leung M.D., Ph.D.

Assistant Professor of Dermatology

University of Pennsylvania

研究点 (1)

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