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临床试验/NCT03103893
NCT03103893已完成1 期

Novel Compositions for Treating or Preventing Dermal Disorders

Drexel University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年9月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
36
试验地点
1
主要终点
Dermal thickness

研究概览

简要总结

This trial examines the impact of a topical formulation of rapamycin on dermal thickness and senescence.

详细描述

Aging of the skin is the most prominent feature of the aging process, being caused by multiple factors such as intrinsic aging process and UV light exposure.

Dermal atrophy, also called skin atrophy or atrophy, is a disorder manifesting thinning or depression of skin due to reduction of underlying tissue. Dermal atrophy is a major clinical problem in the elderly population. Loss of dermal integrity leads to increased fragility of the skin and precludes the use of intravenous lines in many cases. Skin tears are a significant concern in elderly individuals directly related to dermal atrophy. Impairment in wound healing is an important clinical sequelae of reduced dermal integrity leading to an increase in the number of the infections and complications following injury. Seborrheic keratosis, which comprise focal areas of epidermal thickening, can occur, possibly representing a response to damage. It has been estimated that 100% of individuals over 50 years of age harbor at least one of these lesion. There is not treatment for dermal atrophy and seborrheic keritoses require excision if they become large enough to cause discomfort or distress.

Therefore, there is a need to develop novel compositions and methods for treating or preventing certain age-related dermal conditions.

Rapamycin is an FDA approved drug that has been in clinical use for over 15 years. Systemic application of rapamycin has been a central part of immuno suppressive therapy for transplant patients in combination with other immuno suppressants. The safety record for systemic use of rapamycin is excellent and few side effects are associated with extended use.

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

盲法说明

Clinical assessors are blinded to recruitment and treatment assignment.

入排标准

年龄范围
40 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults

排除标准

  • Individuals with any chronic disease will be excluded from the study including those with the following conditions:
  • Any type of Malignancy
  • Severe coronary artery disease
  • HIV infection
  • Hepatitis C or B
  • Any sign of skin disorder or disease aside from normal aging, dermal atrophy, or seborrheic keratoses.
  • Premenopausal women will be excluded
  • Patients taking the following medications will be excluded:
  • Cyclosporin
  • Calcium channel blockers: diltiazem, verapamil
  • Antifungal agents e.g. clotrimazole, fluconazole, itraconazole
  • Antibiotics: clarithromycin, erythromycin, rifampicin
  • Anticonvulsants: carbamazepine, phenobarbitone, phenytoin
  • Antinausea drugs e.g. metoclopramide
  • Other drugs e.g. danazol, protease inhibitors (e.g. for HIV and hepatitis C including ritonavir, indinavir, boceprevir, and telaprevir)
  • Grapefruit juice
  • St John's wort (Hypericum perforatum, hypericin)

研究组 & 干预措施

Rapamycin

Experimental

Rapamycin

干预措施: Rapamycin (Drug)

结局指标

主要结局

Dermal thickness

时间窗: 6-8 months

dermal thickness as assessed by direct measurement

次要结局

  • Gene expression(6-8 months)
  • Seborrheic Keratosis(6-8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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