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临床试验/NCT01289171
NCT01289171已完成不适用

Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients: Prospective Treatment Trial With Topical Glycolic Acid and HPV Genotype Characterization

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Treatment efficacy of 15% glycolic acid lotion for flat warts

研究概览

简要总结

Many human immunodeficiency virus (HIV)-positive children are afflicted with diffuse flat warts that have been recalcitrant to multiple treatments.The aim of this prospective study was to evaluate the efficacy, safety and tolerability of 15% glycolic acid lotion (NeoStrata) for treatment of flat warts in HIV-positive children in Botswana. Additionally, the investigators characterized the flat warts in this population, including Human Papillomavirus (HPV) type(s) and degree of immunosuppression within the patients.

研究设计

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

入排标准

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

入选标准

  • Male or female HIV-positive patients 7 years of age or older with at least 15 flat warts, diagnosed clinically by one dermatologist (RLM), on the face and/or dorsal hands were included in the study.

排除标准

  • Key exclusion criteria included current use of potential wart treatments or other topical OTC products on the affected area(s).

研究组 & 干预措施

Glycolic acid

Experimental

All who met the study criteria commenced once daily use of 15% glycolic acid lotion.

干预措施: Glycolic acid (Drug)

结局指标

主要结局

Treatment efficacy of 15% glycolic acid lotion for flat warts

时间窗: Patients were evaluated every two weeks for eight weeks and monthly for the next eight weeks, for a total monitoring period of 16 weeks.

Our primary objective is to determine the efficacy of 15% glycolic acid lotion for improving the cosmetic appearance of flat warts in HIV infected children and young adults on antiretroviral therapy.

Safety and tolerability of 15% glycolic acid lotion for flat warts

时间窗: Patients were evaluated every two weeks for eight weeks and monthly for the next eight weeks, for a total monitoring period of 16 weeks.

Patients were evaluated for possible side effects of the topical medication, including erythema, scaling, burning, and irritation of the skin in the area applied.

次要结局

  • HPV typing in EV-like flat warts(Biopsies were taken at the first visit, and the HPV typing was performed on all samples after the 16 week monitoring period was complete.)

研究者

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

Carrie Kovarik

Professor of Dermatology

University of Pennsylvania

研究点 (1)

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