NCT02513680

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

June 30, 2015

Last Update Submit

July 31, 2015

Conditions

AgingWrinkles

Keywords

Skin Aginglaser phototherapyRejuvenationInfrared Rays/therapeutic useFemaleHumansEstheticsPhototherapyfacial rejuvenation

Outcome Measures

Primary Outcomes (1)

  • Therapeutic efficacy of LED and Laser therapy in facial photorejuvenation

    Ten weeks

Study Arms (2)

LASER and LED therapy application

ACTIVE COMPARATOR

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

LED Therapy application

ACTIVE COMPARATOR

The second group will use only Amber LED (590 nm - 1.500 mW)

Device: Amber LED

Interventions

Infrared Laser + Amber LEDDEVICE

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.

LASER and LED therapy application
Amber LEDDEVICE

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.

LED Therapy application

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Lívia S Born

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Ana Claudia Fedi

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

June 30, 2015

First Posted

August 3, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 3, 2015

Record last verified: 2015-07