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临床试验/NCT01818167
NCT01818167已完成不适用

A Prospective Multi-Center Blinded, Randomized, Controlled Clinical Trial Comparing the Efficacy of Provodine Topical Body Wash Versus 10% Benzoyl Peroxide Topical Body Wash for the Treatment of Hidradenitis Suppurativa

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年1月5日最近更新:
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
25
试验地点
1
主要终点
Hidradenitis Suppurativa European Research Group (HISERG) scale

研究概览

简要总结

The purpose of this study is to compare the efficacy of Provodine™ topical cream to 10% benzoyl peroxide topical body wash for the treatment of early stage hidradenitis suppurativa.

详细描述

Hidradenitis suppurativa (HS) is a chronic, recurrent inflammatory disease of the skin. It typically manifests as nodules and abscesses that ultimately can progress to form deep sinus tracts, fistulas, and scarring. It affects areas of the body with apocrine gland bearing tissue, including the anogenital, axillary and inframammary regions. The lesions are often very painful and can chronically drain malodorous fluid, which can leave affected individuals uncomfortable and self-conscious, or even debilitated. The pathogenesis of this disease process is not fully understood, and the HS can be difficult to treat. Measures such as topical antibiotic and antiseptic washes are generally thought to be beneficial for the treatment of early stage HS. Although there have been no controlled trials for the treatment of HS, commonly used topical washes currently include benzoyl peroxide and chlorhexidine gluconate.

Provodine™ topical cream was designed to actively kill microbes on the skin for up to 6 hours without resulting in the irritation often associated with repetitive use of antimicrobial products. A blinded controlled comparison of Provodine™ versus the current standard of benzoyl peroxide wash will not only allow for an alternative treatment for early stage HS but also provide an additional tool in the arsenal of treatments for this disease process.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
13 Years 至 120 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For inclusion, the subject must:
  • Be at least 13 years old.
  • Be otherwise healthy.
  • Have a diagnosis of HS.
  • Patients must have Hurley stage I or Stage II HS
  • Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form.
  • Agree to follow and undergo all study-related procedures.
  • If applicable, minors must have permission of legal guardian for participation in the study.

排除标准

  • Subjects who meet the following criteria will be excluded:
  • Patients with HS Hurley stage III will be excluded from participation in the study
  • Patients who are pregnant or breast feeding will not be able to take part in the study due to the unknown effects of the topical medications.
  • Concomitant use of systemic or other topical treatments for HS not involved in current study. For cohort I, no washout period for systemic and/or topical medications will be required. For Cohort II, there will be a 14 day minimum washout period for systemic and topical treatments for HS.
  • Any reason the investigator feels the patient should not participate in the study.
  • If a patient misses ≥ 2 consecutive study visits, the patient will be excluded from further participation in this trial.
  • History of allergy to iodine or benzoyl peroxide.

研究组 & 干预措施

10% Benzoyl Peroxide Topical Body Wash

Active Comparator

Subjects will use 10% benzoyl peroxide twice daily. The product will be applied to the affected areas, left on for 45 seconds, then rinsed off.

干预措施: 10% Benzoyl Peroxide Topical Body Wash (Drug)

Provodine Topical Cream

Active Comparator

Subjects will use Provodine Topical Cream twice daily. The product will be applied to the affected areas, left on for 45 seconds, then rinsed off.

干预措施: Provodine Topical Cream (Drug)

结局指标

主要结局

Hidradenitis Suppurativa European Research Group (HISERG) scale

时间窗: 4 months

Assessment of the degree of involvement of HS will be performed at each study visit using the Hidradenitis Suppurativa European Research Group (HISERG) scale outlined below: 1. Anatomical region involved (axilla, groin, gluteal or other region or inframammary region left and/or right: 3 points per region involved). 2. Number and scores of lesions (abscesses, nodules, fistulas, scars: points per lesion of all regions involved: nodules 2, fistulas 4, scars 1, others 1) 3. The longest distance between two relevant lesions, i.e., nodules and fistulas, in each region, or size if only one lesion (\<5cm 2, \<10cm 4, \>10cm 8) 4. Are all lesions clearly separated by normal skin? In each region (yes 0/no 6) 5. Extent of erythema, edema, pain and purulent discharge of each anatomic site (0-3 for each clinical indicator)

次要结局

  • Skin Irritation Index(4 months)
  • Patient reported Quality of Life Scores on the Dermatology Quality of Life Index and the Skindex-20(4 months)

研究者

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

Iltefat Hamzavi

Senior Staff Physician

Henry Ford Health System

研究点 (1)

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