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Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04834817
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 9, 2021
Sponsor:
Collaborator:
BioPhotas
Information provided by (Responsible Party):
Kristen Kelly, University of California, Irvine

Brief Summary:
The purpose of this study is to evaluate the effect of light therapy on wound healing after laser treatment.

Condition or disease Intervention/treatment Phase
Wound Heal Device: Celluma POD Not Applicable

Detailed Description:
This study sets out to evaluate the effect of a combination of near infrared (830 nm) red (633 nm) and blue (465nm) light-emitting diode (LED) therapy on wound healing after laser application.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: LED treatment
LED treatment with Celluma POD device after laser test area
Device: Celluma POD
A blue and near infrared handheld LED device

No Intervention: Control
No treatment after laser test area



Primary Outcome Measures :
  1. Days to healing [ Time Frame: 56 days ]
    The primary endpoint of this study is time and days to complete healing of the treatment sites. Clinical grading shall be by blinded assessment.


Secondary Outcome Measures :
  1. Pain level [ Time Frame: 56 days ]
    A secondary outcome measure will be post-treatment pain on a 11-point Lickert scale from 0-10. Higher scores mean a worse outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Adults aged 18 years or older with no active cutaneous disease on bilateral ventral biceps, close to the axilla.

Subjects shall have given written informed consent for both the LED therapy and for clinical photography.

Exclusion Criteria:

Patients will be excluded if any of the exclusion criteria applies

  • Subjects refuse to give informed consent for either the phototherapy or the clinical photography.
  • Subjects have previous photosensitivity problems (solar urticaria, etc.).
  • Subjects are taking any systemic drug or applying any topical drug with known photosensitizing properties.
  • Subjects taking any systemic drug with known immunosuppressant properties.
  • Subjects applying any medications to the research site (inner biceps, close to the axilla).
  • Subjects have medical or psychosocial conditions associated with a risk of poor protocol compliance.
  • Subjects are smokers or have smoked within the last 30 days prior to the trial.
  • Subjects have epilepsy or a history of seizures
  • Subjects currently taking cortisone injections or any other kind of steroid injections(s)
  • Subjects with known cancer tumor in the treatment area or metastasis

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): NCT04834817


Contacts
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Contact: Hanna Kim, MA 949-824-9265 hhkim3@uci.edu

Locations
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United States, California
UCI Beckman Laser Institute and Medical Clinic Recruiting
Irvine, California, United States, 92697
Contact: Hanna Kim, MA         
Sponsors and Collaborators
University of California, Irvine
BioPhotas
Investigators
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Principal Investigator: Kristen Kelly, MD University of California, Irvine
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Responsible Party: Kristen Kelly, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT04834817    
Other Study ID Numbers: 2021-6401
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No