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Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention

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ClinicalTrials.gov Identifier: NCT03795116
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Jared Jagdeo, MD, MS, State University of New York - Downstate Medical Center

Brief Summary:
Skin scarring (fibrosis) is a common complication in the wound healing process and remains a therapeutic challenge. Scar formation often occurs following injury to the skin such as surgery, trauma, and burns. The goal of this study is to evaluate the safety and efficacy of visible red light as a modality to reduce skin scarring after mini-facelift surgery. Based on laboratory data, light emitting diode-red light (LED-RL) phototherapy may lessen post-surgical skin fibrosis clinically.

Condition or disease Intervention/treatment Phase
Fibrosis Skin Scarring Skin Wound Hypertrophic Scar Scar Keloid Device: LED-RL phototherapy Device: Mock irradiation Phase 2

Detailed Description:

Skin fibrosis is a significant global health problem that has a profoundly negative impact on quality of life. Characterized by excessive fibroblast proliferation and collagen deposition, skin fibrosis underlies a wide spectrum of dermatologic conditions ranging from pathologic scars secondary to injury (e.g., burns, surgery, trauma) to immune-mediated diseases. Effective anti-scarring therapeutics remain an unmet need, underscoring the importance of developing novel approaches to treat and prevent skin fibrosis.

In vitro data show that LED-RL can modulate key cellular and molecular processes involved in skin fibrosis. Two phase I clinical trials (STARS 1 and STARS 2) demonstrated the safety and tolerability of LED-RL at fluences of 160 J/cm2 up to 480 J/cm2 on normal human skin. The administration of LED-RL phototherapy in the early postoperative period may optimize wound healing and prevent excessive scarring. The results from this study may change the current treatment paradigm for fibrotic skin diseases and help to pioneer LED-RL as a safe, non-invasive, cost-effective, portable, at-home therapy for scars.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: This is a single-blind study. Participants and clinicians involved in subjective efficacy assessments will be blind to the study intervention (LED-RL phototherapy versus mock therapy). The principal investigator, along with the research coordinator who administers the LED-RL phototherapy, will be aware of each participant's treatment assignment.
Primary Purpose: Treatment
Official Title: Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: LED-RL phototherapy
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Device: LED-RL phototherapy
The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.
Other Name: Omnilux handheld LED system (GlobalMed Technologies, Glen Ellen, CA)

Sham Comparator: Mock irradiation
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Device: Mock irradiation
The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.




Primary Outcome Measures :
  1. Change in scar pliability between the treated and control incision sites as measured by skin elasticity at three follow-up time points compared to baseline [ Time Frame: 1 month, 3 months, 6 months ]
    The ElastiMeter, a non-invasive indentation instrument, will be used to evaluate skin elasticity (i.e., skin stiffness) of the LED-RL-treated scar versus the untreated scar. Skin elasticity is measured in Newtons/meters (N/m).

  2. Change in scar pliability between the treated and control incision sites as measured by skin induration at three follow-up time points compared to baseline [ Time Frame: 1 month, 3 months, 6 months ]
    The SkinFibroMeter, a non-invasive indentation instrument, will be used to evaluate the induration of the skin and subcutaneous tissue (i.e., hardness) of the LED-RL-treated scar versus the untreated scar. Skin induration is measured in Newtons (N).


Secondary Outcome Measures :
  1. Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: 1 month, 3 months, 6 months ]
    The two subscales of the POSAS each consist of six items rated from 1 to 10, where 1 is "normal skin" and 10 is the "worst imaginable scar". The observer (i.e., investigator) evaluates scar vascularity, pigmentation, thickness, relief, pliability, and surface area while the patient assesses pain, itching, color, stiffness, thickness, and irregularity. The scores of each of the six items are summed for a total score (range 6 to 60).

  2. Visual analog scale (VAS) scoring of digital photographs of scars [ Time Frame: 1 month, 3 months, 6 months ]
    The scar images will be rated by two independent, blinded dermatologists using a VAS. The VAS is presented as a 10 cm horizontal line, where the extreme ends of 0 indicates "normal skin" and 10 corresponds to the "worst possible scar," for each of the following scar attributes: pigmentation, vascularity, observer comfort, contour, and overall severity.

  3. Dermal collagen concentration [ Time Frame: 1 month, 3 months, 6 months ]
    A non-invasive, handheld diffuse reflectance probe will be used to measure collagen concentration in the dermis at each incision site.

  4. Dermal water concentration [ Time Frame: 1 month, 3 months, 6 months ]
    A non-invasive, handheld diffuse reflectance probe will be used to measure water concentration in the dermis at each incision site.

  5. 3D imaging analysis: pigmentation of scar tissue [ Time Frame: 1 month, 3 months, 6 months ]
    A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of pigmentation at each incision site.

  6. 3D imaging analysis: vascularity of scar tissue [ Time Frame: 1 month, 3 months, 6 months ]
    A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of vascularity at each incision site.

  7. 3D imaging analysis: volume of elevation of scar tissue [ Time Frame: 1 month, 3 months, 6 months ]
    A 3D digital imaging system will be used to construct 3D images of the scars for skin profilometry analyses, including quantitative measurements of tissue volume at each incision site.

  8. Histological analysis: collagen content of scar tissue [ Time Frame: Postoperative days 0 and 30 ]
    The histological changes that occur in vivo in response to LED-RL phototherapy will be evaluated by examination of pre- and post-treated skin tissue. Skin specimens will be obtained via optional 2 mm punch biopsy and stained for collagen fibers.

  9. Number of participants experiencing adverse events in each treatment group [ Time Frame: 3 weeks ]
    Subjects will be provided with a daily diary to record any adverse events experienced during the three-week intervention period. Treatment sessions will be monitored closely for the occurrence of any safety issues or adverse events, as reported by the subject or observed by the clinical research team.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of written informed consent for all study procedures
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Suitable candidate for elective mini-facelift surgery
  • Pass a screening photosensitivity test

Exclusion Criteria:

  • Current use of any photosensitizing medications
  • Light-sensitive conditions
  • Diabetes mellitus
  • Systemic lupus erythematosus
  • Current tobacco use
  • History of bleeding or coagulation disorder
  • Lax skin associated with genetic disorders
  • Open wounds on the face or neck
  • Fibrotic skin disease, pre-existing scar(s), or other skin conditions affecting the periauricular skin
  • History of surgery or procedure involving or affecting the periauricular skin within the past 6 months (e.g., prior facelift, fillers, laser therapy)
  • Tattoos that cover the proposed treatment sites on the periauricular skin
  • Any other medical condition(s) that could be compromised by exposure to the proposed treatment

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): NCT03795116


Contacts
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Contact: Julie Nguyen, MD 507-400-3376 LABresearch@downstate.edu

Locations
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United States, New York
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Julie Nguyen, MD    507-400-3376    LABresearch@downstate.edu   
Principal Investigator: Jared Jagdeo, MD, MS         
Sponsors and Collaborators
State University of New York - Downstate Medical Center

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Responsible Party: Jared Jagdeo, MD, MS, Associate Professor of Dermatology, State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT03795116     History of Changes
Other Study ID Numbers: 1304108
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Jared Jagdeo, MD, MS, State University of New York - Downstate Medical Center:
Light emitting diode
Light emitting diode-red light
Visible red light
Skin fibrosis
Wound healing
Scarring

Additional relevant MeSH terms:
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Fibrosis
Hypertrophy
Cicatrix
Cicatrix, Hypertrophic
Pathologic Processes
Pathological Conditions, Anatomical