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Effects of Application LED Therapy and Laser Therapy in Facial Rejuvenation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02513680
Recruitment Status : Completed
First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Patricia Viana da Rosa, Federal University of Health Science of Porto Alegre

Brief 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.

Condition or disease Intervention/treatment Phase
Aging Wrinkles Device: Infrared Laser + Amber LED Device: Amber LED Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Application LED Therapy and Laser Therapy in Facial Rejuvenation: Pilot Study
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Active Comparator: LASER and LED therapy application
The first group will use the two techniques under study combined: Infrared Laser + Amber LED (830 nm - 150mW + 590 nm - 1.500 mW)
Device: Infrared Laser + Amber LED
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.

Active Comparator: LED Therapy application
The second group will use only Amber LED (590 nm - 1.500 mW)
Device: Amber LED
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.




Primary Outcome Measures :
  1. Therapeutic efficacy of LED and Laser therapy in facial photorejuvenation [ Time Frame: Ten weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513680


Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Investigators
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Principal Investigator: Lívia S Born Federal University of Health Science of Porto Alegre
Principal Investigator: Ana Claudia Fedi Federal University of Health Science of Porto Alegre
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Responsible Party: Patricia Viana da Rosa, Adjunct Professor, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT02513680    
Other Study ID Numbers: 36980514.0.0000.5345
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015
Keywords provided by Patricia Viana da Rosa, Federal University of Health Science of Porto Alegre:
Skin Aging
laser phototherapy
Rejuvenation
Infrared Rays/therapeutic use
Female
Humans
Esthetics
Phototherapy
facial rejuvenation