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临床试验/NCT03573076
NCT03573076终止4 期

Treatment of Photodamaged Skin of the décolleté With Fractional Laser, Radio-frequency Microneedling, and Photodynamic Therapy

Merete Haedersdal2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年9月10日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
发起方
入组人数
12
试验地点
2
主要终点
Clinical improvement of photodamage

研究概览

简要总结

This study investigates a non-ablative fractional thulium laser and a radio-frequency microneedling device as pre-treatment for combination photodynamic therapy in treatment of photoaged skin and actinic keratoses.

详细描述

Photoaging of skin and actinic keratoses Photoaging of the skin is the result of UV radiation in chronic sun exposure and its deleterious effects. Photoaging includes fine and coarse wrinkles, roughness, laxity, mottled pigmentation, coarseness, sallowness, telangiectasia, solar lentigines and dysplastic actinic keratoses. The process can be of both cosmetic and medical importance. Actinic keratoses (AK) are common dysplastic pre-malignant lesions that may develop into a malign invasive squamous cell carcinomas (SCC). SCCs have metastatic potential at up to 3%. The risk of malign transformation from AK to SCC is highest in chronic sun-damaged skin with confluent field-cancerization from multiple AK. National guidelines recommend treatment of the entire field of sun damaged skin with photodynamic therapy and several topical drugs, e.g. imiquimod, diclofenac, ingenol mebutate, and 5-fluoruracil. Repeat treatments are usually necessary to achieve the desired results in patients with chronic sun damaged skin.

Photochemical treatment with photodynamic therapy

Photodynamic therapy (PDT) is a treatment that uses a photosensitizer drug activated in the skin by light in the visible spectrum. Methyl aminolevulinate (MAL) is a photosensitizing agent with great affinity for dysplastic cells, and transforms into the light-sensitive Protoporphyrin PpIX. When exposed to light, photoactivated PpIX catalyzes a reactive oxygen species reaction, which leads to irreversible cell apoptosis of the dysplastic or neoplastic tissue. PDT can be used as treatment of a wide range of photoaging skin defects including actinic keratoses, and is exceedingly well suited for treatment of larger skin areas. PDT produces cosmetically pleasing results in extension of the excellent AK clearance.

Physical intervention with fractional laser and light-based interventions

Fractional laser and light-based treatments with lasers and microneedles are approaches that can be applied very precisely, and can be used to rejuvenate photodamaged skin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Décolleté with chronic field-change photodamaged skin.
  • Area with visually homogenous photodamage.
  • Provide informed written consent.
  • Fertile women must provide a negative U-hCG pregnancy test at the time of inclusion, and use safe anticontraceptive during the entire study period, e.g. oral hormonal contraceptives, intrauterine devices, subdermal implantation, or hormonal vaginal ring.

排除标准

  • Treatment of actinic keratoses in the décolleté area within the last 30 days.
  • Porphyria.
  • Pregnant or nursing women.
  • Skin cancer (invasive, in situ), keratoacanthoma, or other infiltrating tumors in the study area.
  • Known tendencies to produce hypertrophic scarring or keloids.
  • Allergies against Metvix creme solution, peanuts, or soy.
  • Considered unable to follow the study protocol, e.g. alcohol dependence syndrome.

结局指标

主要结局

Clinical improvement of photodamage

时间窗: 12 weeks

5-point categorial scale of photodamage severity, measuring changes in skin texture, pigmentation, telangiectasia, and wrinkles. Scores are 0, 1, 2, 3, and 4, for none, mild, moderate, severe, and very severe, respectively. A reduction in score from initial scoring to post-treatment is desirable.

次要结局

  • Treatment effect on actinic keratoses(12 weeks)
  • Severity of local skin reactions(7 days)
  • Presence of perceived pain during treatment(0 days)
  • Cosmetic results(12 weeks)
  • Protoporphyrin IX (PpIX) fluorescence uptake(0 days)
  • Safety including wounding, scarring, hyper and hypo pigmentation(12 weeks)

研究者

发起方
Merete Haedersdal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Merete Haedersdal

Professor, Physician Consultant

Bispebjerg Hospital

研究点 (2)

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