Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention
Condition: Fibrosis; Skin Scarring; Skin Wound; Hypertrophic Scar; Scar; Keloid
MeSH terms: Fibrosis; Cicatrix; Cicatrix, Hypertrophic
Intervention: LED-RL phototherapy; Mock irradiation
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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.
Enrollment: 30.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Light emitting diode; Light emitting diode-red light; Visible red light; Skin fibrosis; Wound healing; Scarring

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.
    

Eligibility 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