Wounds Clinical Trial
Official title:
Phase I Study of High Fluence Light Emitting Diode-Red Light (LED-RL) in Human Skin
The goal of this study is to establish the safety of high fluence LED-RL from 160 J/cm2 up to 640 J/cm2 in healthy subjects. The hypothesis is that high fluence LED-RL phototherapy is safe in human skin.
Skin fibrosis is involved in a variety of pathologic processes ranging from exuberant scar formation secondary to surgery or trauma, as in hypertrophic and keloid scars, to immune-mediated processes such as scleroderma and chronic graft-versus-host disease. As highlighted by quality-of-life studies, skin fibrosis imparts a significant socioeconomic burden due to the functional, aesthetic, and psychosocial impact it has on a patient's life. The effects of visible light, while common in the environment (visible spectrum accounts for 44% of total solar energy), remain undefined. An important safety feature of visible red light (600 nm to 700 nm) is that it does not generate pro-carcinogenic DNA damage as does ultraviolet (UV) light. Recently published clinical observations indicate that red light in combination with other modalities such as photosensitizers in combined red light photodynamic therapy can lessen skin fibrosis. However, preliminary in vitro data generated by the investigator's research group suggests that red light can function as a stand-alone treatment, eliminating the side-effects of chemical photosensitizers and the potential long-term harm of current UV therapy. Furthermore, commercially available light emitting diode-red light (LED-RL) units exist and are already FDA-cleared for other dermatological uses (such as rhytides and acne), thus clinical translation for use in skin fibrosis could occur relatively quickly following safety and efficacy demonstration. Developing high fluence LED-RL phototherapy as a treatment for skin fibrosis would represent an important advance in scarring conditions that lacks the serious systemic side effects associated with immunomodulatory agents (such as oral steroids); avoids the need for invasive, painful injections with anti-fibrotic agents (such as intralesional steroids, 5-fluorouracil and bleomycin); and eliminates the UV-induced DNA damage associated with skin cancer and photoaging that are associated with current UVA/UVA1 and UVB/narrowband UVB phototherapy. To the investigator research group's knowledge, no clinical trials have been performed to determine the safety of high fluence LED-RL for treatment of skin fibrosis. Therefore, the innovation of this approach is that the investigator research group intend to study high fluence LED-RL as a safe modality for treatment of skin fibrosis. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02865902 -
Low-level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness
|
N/A | |
Terminated |
NCT01191567 -
Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
|
N/A | |
Completed |
NCT01227759 -
Tyrosur® Gel-Investigation on Wound Healing Efficacy
|
Phase 2 | |
Recruiting |
NCT00737425 -
Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery
|
Phase 4 | |
Completed |
NCT00746109 -
Study of Wound Packing After Superficial Skin Abscess Drainage
|
Phase 4 | |
Terminated |
NCT00762138 -
The AutoloGelâ„¢ Post-Market Surveillance (TAPS) Program
|
N/A | |
Withdrawn |
NCT00234559 -
Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis
|
N/A | |
Not yet recruiting |
NCT03872544 -
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Enrolling by invitation |
NCT03880188 -
Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Recruiting |
NCT05588583 -
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
|
N/A | |
Completed |
NCT02591537 -
OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University
|
N/A | |
Completed |
NCT00792688 -
Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation
|
Phase 2 | |
Recruiting |
NCT05608317 -
A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
|
N/A | |
Recruiting |
NCT02195063 -
Survey Study for Pain Management, Wound Care, Scar Care or UDT
|
Phase 4 | |
Completed |
NCT01319149 -
A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes
|
N/A | |
Completed |
NCT00153452 -
Workplace Productivity of Persons Who Use Controlling Behavior With Intimate Partners
|
N/A | |
Completed |
NCT06083740 -
A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
|
||
Not yet recruiting |
NCT02672280 -
Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02314416 -
Stem Cells In Wound Healing With Collagen Matrix as a Carrier
|
Phase 4 | |
Recruiting |
NCT01454167 -
Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications
|
N/A |