跳至主要内容
临床试验/NCT03224715
NCT03224715撤回不适用

Actinic Cheilitis Pre-Treated With DNA Repair Enzyme Cream

Loyola University2 个研究点 分布在 1 个国家开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Rate of complete clearance vs partial response, determined clinically and by high-resolution macrophotography through blinded dermatologist evaluation

研究概览

简要总结

It is well known that ultraviolet (UV) light causes sunburn and DNA damage that can lead to skin cancer. Despite preventative measures of sunscreens and other topicals the incidence of skin cancers continues to increase every year. Chronic exposure can lead to development of both basal and squamous cell carcinoma that also is correlated to the risk of melanoma. When epidermal keratinocytes are exposed to UV radiation, they form cyclobutane pyrimidine dimmers (CPDs), 6-pyrimidine-4-pyrimidones (6-4-PPs), and oxygen radicals that alter the structure of nucleotides. When these lesions are not repaired, DNA replication is altered that leads to mutations in p53 and PTCH tumor suppressor gene and ultimately tumor development. It has been discovered that intracellular delivery of bacterial DNA incision repair enzyme T4 endonuclease V DNA repair enzymes can repair sun induced damaged DNA in patients with xeroderma pigmentosum4,. Yarosh et al also showed that T4 endonuclease V DNA repair enzymes are specific to reducing the amount of cyclobutane pyrimidine dimers and were found to lower the rate of new actinic keratoses compared to placebo lotion by 68% with no adverse effects observed. Additionally Yarosh et al also showed that T4N5 liposomes can repair keratinocyte DNA in skin cancer patients. This study will examine if pretreating actinic cheilitis with DNA repair enzyme cream before standard treatments can decrease the need for additional and possibly more aggressive therapies, decrease the surface area of affected areas, and possibly improve skin thickening and texture.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • 18 years or older with clinically confirmed actinic cheilitis
  • Fitzpatrick Type I, II, III, or IV skin.
  • At least 20% of upper and/or lower lip affected by actinic cheilitis

排除标准

  • Pregnant or nursing
  • Allergies to any component of the study topical medication
  • Prior treatment of actinic cheilitis within the past month, including cryotherapy, PDT, 5-FU, Picato, Retinoid, Diclofenac
  • Prior ablative laser therapy to the lips, including fractional erbium and CO2 lasers.
  • Prior use of lip fillers
  • Presence of any skin disease that might interfere with the study treatments, including, but not limited to, rosacea, atopic dermatitis, lip lickers dermatitis, perioral dermatitis, perleche, active herpes infection.
  • Presence of hypertrophic and hyperkeratotic lesions or cutaneous horns within the treatment area
  • Any diagnosis of active, untreated skin cancer of the lip

研究组 & 干预措施

Actinic Cheilitis patients

Experimental

干预措施: DNA Repair Enzyme Cream (Other)

结局指标

主要结局

Rate of complete clearance vs partial response, determined clinically and by high-resolution macrophotography through blinded dermatologist evaluation

时间窗: 12 weeks

Percentage of patients with no clinically visible remaining lesions in treated area For partial responders: differentiate approximate surface area of affected lips, expressed as a percentage (0 to 100), compared with that prior to treatment

次要结局

未报告次要终点

研究者

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Tung

Director of Dermatology

Loyola University

研究点 (2)

Loading locations...

相似试验