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临床试验/NCT02513680
NCT02513680已完成不适用

Effects of Application LED Therapy and Laser Therapy in Facial Rejuvenation: Pilot Study

Federal University of Health Science of Porto Alegre0 个研究点目标入组 32 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
主要终点
Therapeutic efficacy of LED and Laser therapy in facial photorejuvenation

研究概览

简要总结

In today's society, the search for keeping up with the appearance with no visible signs of aging has become common. Therefore, many therapies to try to mitigate these senility markers are present in specialized clinics. Such therapies seek grounding in the theories of how the skin and its appendages respond to the aging process, causing this way, they can be created ways to slow or minimize wrinkles and other consequences of this natural biological process. However, this process can be accelerated by exposure to ultraviolet light such as to toxic substances as well as tobacco, among others. The low-power laser and light emitted diode (LED) characterized by being non-ablative light source, which means phototherapy which does not cause physical damage to the epidermis, as the case of CO2 laser ablative and other methods. This study has the purpose of comparing the effects of combined application of low level laser with LED and LED action alone in facial rejuvenation. For this, the analysis of these effects will be conducted through digital photography, blinded assessment and customer satisfaction questionnaire.

详细描述

This is a pilot study seen the lack of studies on the subject chosen for a sample calculation accurately be defined. This will be done by 32 volunteers, respecting the criteria for inclusion and exclusion previously cited by reading and signing the Informed Consent and Clarified. The sample comprises a total of 30 subjects, divided randomly into two groups with 16 subjects in each. The first group will make use of both techniques in combined study: Infrared Laser and Led Amber. The second group, in turn, will use only the Led Amber.These will be allocated randomly and intervention will be simple blind.They will be held 10 sessions in individual applications, both group 1 (Laser and LED) and group 2 (LED) and applications for two groups will occur once per week. Group 1 will make the application of the two techniques on the same day session. Both will be applied in the following areas of the face: chin / perioral, nasolabial folds, periorbital, frontal and glabellar region. Both groups act as their own controls before starting the sessions, to ensure that the changes observed in the skin is caused by the treatment of fact and not the environment. For this, the volunteers will be accompanied during the first month, with completion of a photograph at the beginning of the month to another month-end, as well as a questionnaire at the end of 30 days.

To monitor the results, will be held 4 shoots of the subjects in the study. The first session will take place at the first meeting with the patients, who will undergo a 4-week follow-up without using any methodology. After these four weeks, a new shoot will be held to determine whether the environment was able to promote changes in the skin of patients or not. After this, it will start to bare-sessions. After five sessions of treatment, a new picture for monitoring will be held, and repeated this procedure at the end of treatment for so yes, compare the images and get search results.

To carry out the photos, there will be a standard procedure in order to maintain quality, the angle and the light always the same, so that the results observed can be truthful fact. Initially, the face of the patient will be cleaned, particularly aiming at the removal of cosmetic and excess oil on the surface to be photographed. This will precede the photographic record in at least 5 minutes so that friction marks and flushing fall apart.

Afterwards, the patients with the prisoners hair (or using burrows), will be photographed standing in front and lateral planes (both sides), parallel to the plane of the camera sensor. To better guide them, will be applied on the floor marks with the positions of the feet, to be followed.A camera mounted on the tripod, level and horizontal position, with the 105mm lens will be placed in proper height for framing the mouth, forehead and brows. The framework of each area will follow the alignment of facial landmarks to the camera's viewfinder grid in live view mode.

To photograph the brow area both iris will be aligned with the intersections between the line dividing the room and the lower horizontal lines that divide the extreme vertical side rooms of the grid. To shoot the mouth area "Cheilion" the two points will be aligned respectively with the intersections between the line that bisects the grid and the lines that divide the extreme horizontal side rooms. To photograph the area of the forehead (both sides) and the "Exocanthion" and "Otobasion Superious" points will be aligned with the intersections between the line that bisects the grid and the lines that divide the extreme horizontal side rooms. The flash is mounted on the hot shoe of the camera, set in TTL mode with the driven diffuser and will have its head directed forward. The camera will be displayed in manual mode, with f5.6 aperture, shutter speed to 1/60 second and 200 ISO.

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
30 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients study present ages 30 and 50;
  • Wrinkles compatible with the G2 and G3 stages measured according Glogau scale;
  • Phototypes consistent with those described and between FZ1 to FZ4 according to Fitzpatrick scale;
  • Patients without previous hypersensitivity reaction
  • Patients must agree and sign the consent form and clarified.

排除标准

  • Patients who present wrinkles compatible with the G1 and G4 stages of Glogau scale;
  • Patients who present FZ5 and FZ6 phototypes according to Fitzpatrick scale to increase the risk of burns from the treatment.
  • Patients who have experienced any hypersensitivity reaction in some prior treatment has been paid;
  • Volunteers who are being subjected to treatments with acids synthesized from vitamin A ( acid retinoic , Retinol A, Vitanol A, Retin , Isotretinoin , tretinoin ) and Vitamin C (creams , serums , capsules ) and / or tetracycline and / or which have made facial aesthetic treatments

结局指标

主要结局

Therapeutic efficacy of LED and Laser therapy in facial photorejuvenation

时间窗: Ten weeks

次要结局

未报告次要终点

研究者

发起方
Federal University of Health Science of Porto Alegre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Viana da Rosa

Adjunct Professor

Federal University of Health Science of Porto Alegre

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