Effects of Application LED Therapy and Laser Therapy in Facial Rejuvenation
Condition: Aging; Wrinkles
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      At the end of the collection and collation, registration and randomization of the obtained
      photographs, there will be the evaluation of research students, who will receive the photos
      in random order and will have to put them in expected development order for a rejuvenation
      treatment. After learning the correct order, there will quantify the improvements in fine
      lines of the four areas chosen for analysis. In addition, two blind evaluators will be
      invited to participate in the project by analyzing the same way that researchers students.
      The external evaluators will be the ones who will have knowledge of what method the person
      was exposed. The evaluator will not know whether or not a placebo group in the study. Still,
      it is important to consider that the designated evaluator will be a person with extensive
      knowledge about the skin and possible treatments the same, so you can see exactly if there
      were no improvements or the skin of the participants. The analysis of the photos will take
      place in three steps:

      STEP 1:

      Slides with 3 or 4 photographs of each subject in random order (black and white photographs
      to color hair, earrings, not to interfere in the result).

      The evaluator should classify the images in the order of 1-4, with 1 being the worst picture,
      and 4 the best (relative expression lines, skin texture and brightness) (it is expected that
      the treatment has left the skin better, so this sort order).

      They will be received 4 slides pertaining to each subject, each containing the pictures of
      the respective regions assessed: frontal, nasolabial, periorbital, glabellar. Along with
      this, evaluators will be delivered to a table so that they can put the sort order of 1-4 each
      presented slide.

      STEP 2:

      Slide with a picture before starting treatment and the final photograph arranged
      chronologically (photographs in black and white).

      The assessor should note the first and last picture of each region of each treated patient (4
      regions per patient) and classify the changes in one of the degrees of the scale below:

      0% = no change regarding the improvement of fine lines / wrinkles.

      1% - 25% = little change regarding the improvement of fine lines / wrinkles, difficult to
      observe 25-50% = there has been a change regarding the improvement of fine lines / wrinkles,
      but nothing extremely significant 50% or more = a change in relation to improvement of fine
      lines / wrinkles is visible, the skin really improved considerably

      STEP 3:

      Slides containing two images of each patient in a more central area of the face (Vintage
      Photography).

      The evaluator will receive the slides containing a photograph before the start of treatment
      and the last shot of each volunteer performed relating to a face of the central region. It is
      the evaluator understand the following items:

        1. Voluntary skin had spots? Yes or no?

        2. If stains showed there was a difference in the amount (uniformity) of the skin before
           and after treatment? Yes or no?

      In addition, throughout this study of customer satisfaction questionnaires will be carried
      out in order to monitor whether the patient is enjoying the treatment, it is believed that is
      actually running (sorting qualitivamente the improvement of fine lines) and recommend this to
      other people.Thus, the treatment becomes, in general, valuable, since it is known that on the
      market, the transmission from one person to another feature of procedures that results is an
      efficient form of this disclosure. Such tests will be done in the middle of treatment (5
      sessions) and at the end of it (10 sessions) to compare whether there was a change of the
      view in the meantime.
    

Intervention name(s): Infrared Laser + Amber LED; Amber LED
Intervention type(s): Device; Device
Intervention description(s): This group will make the application on the machine program that uses laser and led together to photorejuvenation . Laser is applied for 30 seconds and soon after begins the LED by 2:30 minutes in each region to apply.; This group will make the application on the machine program that uses LED photorejuvenation only 3 minutes of time for each area to be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Skin Aging; laser phototherapy; Rejuvenation; Infrared Rays/therapeutic use; Female; Humans; Esthetics; Phototherapy; facial rejuvenation