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临床试验/NCT02677194
NCT02677194已完成不适用

Stimulation of Cutaneous Healing Processes With LED: a Controlled Comparative Study to Identify Optimal Settings

Centre Hospitalier Universitaire de Nice0 个研究点目标入组 10 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
主要终点
Effect of LED treatement

研究概览

简要总结

The aim of this study is to assess cutaneous healing process under LED exposition on 10 healthy subjects pre-treated with fractional CO2 laser on mini-zones on forearms.

详细描述

Cutaneous healing is a physiological process that occurs in many occasions: posttraumatic, post-burn, but also in postsurgery or aesthetic interventions. Most often, topical products are used to create a favorable environment for wound healing.

LED (Light Emitting Diode) are light emitting diodes which produce monochromatic or non-coherent polychromatic radiation when an electric current passes through them. Some LED emitting wavelengths in the visible or near infrared have been reported to promote wound healing. In the literature, in vitro studies showed stimulation of fibroblast and keratinocyte proliferation under the effect of irradiation by the LED. Animal studies have also shown that some LED treatments were able to stimulate healing and angiogenesis. Despite existence of strong data in in vitro and animal studies, the clinical data in humans regarding wound healing are still very poor. Thus, it is still not clear whether the LEDs have a real interest in skin healing, and if so, what are the wavelengths and optimal parameters. Despite this, the LEDs are used widely, unfortunately without a clear demonstration of their effectiveness and without any determination of optimal parameters of treatments that could guide clinicians.

The main objective of the study is to evaluate the efficacy at day 3 of different parameters of LED to enhance wound healing after dermabrasion with CO2 fractional laser on mini-zones on 10 healthy volunteers.

Design of the study:

  • screening visit (day-7 to day-21): information of the patient, verification of inclusion criteria , preselection of 7 mini-zones, collection of the informed consent. Clinical examination, vital signs. Pregnancy test for women old enough to procreate.
  • V1 (inclusion): clinical examination, vital signs, new pregnancy test for the women old enough to procreate, randomization for the allocation of treatments (LED parameters) on 7 mini-zones of 1,5x1,5 cm at the level of forearm, one of them is allocated to control ( only laser). Dermabrasion by fractional laser CO2 ablative, evaluation of the pain on every zone by VAS post-act. Exposition to LED (630nm, 830nm and 590 nm). Water loss measure and colorimetry before and after laser and after the exposition to LED. Clinical evaluation of local tolerance post-laser and post-LED + standardized photographs. Application of a healing cream twice a day on area treated until healing.
  • V2 (24 hours): evaluation local tolerance, photos, colorimetry, waterloss measure before the session LED.
  • V3 (48 hours): evaluation local tolerance, photos, colorimetry, waterloss measure before the session LED
  • V4 (72 hours): clinical exam, clinical local tolerance evaluation and healing, waterloss measure, colorimetry and standardized photos
  • V5 ( J7): evaluation local tolerance, colorimetry and waterloss measures, standardized photos . V6 (J21+/-3 days): clinical exam, clinical local tolerance evaluation and healing, waterloss measure, colorimetry and standardized photos. Final visit of the study

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
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

  • • Male or female aged 18 years or more
  • Phototype I to III
  • No allergy to topical anesthesia
  • Healthy subject with no medical history of dermatological or systemic disease
  • Normal homogeneous skin on forearms without excessive hair growth
  • No medical history of keloïds or hypertrophic scar
  • No history of post-inflammatory hyperpigmentation
  • No congenital methemoglobinemia or porphyria
  • No oral retinoids treatment in the 6 previous months before starting the study
  • No Topical or systemic corticosteroids or immunosuppressive or photosensitive drugs in the previous month
  • No medical issue that could interfere with the results of the study according to investigator opinion

排除标准

  • • Subject within exclusion period according to the volunteer national file
  • Childbearing or breastfeeding women
  • Use of topical cosmetics or drugs in the 48 previous hour before inclusion
  • Antalgic treatment in the 24 previous hour before inclusion

结局指标

主要结局

Effect of LED treatement

时间窗: at day 3

The effect of LED treatment on skin healing will be estimated by measure on colorimetry (day 3 versus day 0)

次要结局

  • Waterloss measure(at day 3)
  • Tolerance(at day 3 (V4))

研究者

申办方类型
Other
责任方
Sponsor

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