Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02630303
Other study ID # 15-12-00756
Secondary ID
Status Completed
Phase Phase 1
First received December 9, 2015
Last updated March 29, 2017
Start date January 2016
Est. completion date March 2017

Study information

Verified date March 2017
Source VA Northern California Health Care System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Read more »
Read more »

Study Design


Intervention

Device:
LED-RL Phototherapy
The maximum recommended starting dose (MSRD) (160 J/cm2) will be administered to Group 1's LED-RL phototherapy randomized subjects and the LED-RL dose will be escalated in subsequent groups using the classical method for dose escalation as described by Spilker: starting with dose (X) increased by an equal amount (in this instance: X=160 J/cm2, 2X=320 J/cm2, 3X=480 J/cm2, 4X=640 J/cm2). Common expected procedure side effects are mild and temporary, including warmth, redness (erythema) and swelling (edema). The maximally tolerated dose (MTD) is defined as the dose level below the dose producing unacceptable but reversible toxicity and is considered the upper limit of subject tolerance. All subjects will receive total of nine LED-RL phototherapy, three times per week for three consecutive weeks.
Mock Therapy
Mock therapy will be administered to mock therapy randomized subjects using the mock therapy unit and only generates warmth and does not emit LED-RL. All subjects will receive total of nine mock therapy procedures, three times per week for three consecutive weeks.

Locations

Country Name City State
United States Sacramento VA Medical Center Mather California

Sponsors (3)

Lead Sponsor Collaborator
Jared Jagdeo, MD, MS East Bay Institute for Research and Education, VA Northern California Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (5)

Jagdeo JR, Adams LE, Brody NI, Siegel DM. Transcranial red and near infrared light transmission in a cadaveric model. PLoS One. 2012;7(10):e47460. doi: 10.1371/journal.pone.0047460. Epub 2012 Oct 15. — View Citation

Lev-Tov H, Mamalis A, Brody N, Siegel D, Jagdeo J. Inhibition of fibroblast proliferation in vitro using red light-emitting diodes. Dermatol Surg. 2013 Aug;39(8):1167-70. doi: 10.1111/dsu.12212. — View Citation

Mamalis A, Jagdeo J. Light-emitting diode-generated red light inhibits keloid fibroblast proliferation. Dermatol Surg. 2015 Jan;41(1):35-9. doi: 10.1097/01.DSS.0000452650.06765.51. — View Citation

Sadick NS. A study to determine the efficacy of a novel handheld light-emitting diode device in the treatment of photoaged skin. J Cosmet Dermatol. 2008 Dec;7(4):263-7. doi: 10.1111/j.1473-2165.2008.00404.x. — View Citation

Sadick NS. Handheld LED array device in the treatment of acne vulgaris. J Drugs Dermatol. 2008 Apr;7(4):347-50. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of procedure-related common expected procedure outcomes and adverse events (safety and tolerability) To evaluate safety of high fluence LED-RL Phototherapy by recording any common expected procedure outcomes [warmth, erythema (redness), and edema (swelling) that are mild, self-limited, and are expected to last less than 24 hours] and adverse events (including: second-degree or higher skin burning or blistering, erythema lasting more than 24 hours, severe swelling, pain, ulceration, change in sensation, and/or muscle weakness], via assessment during and immediately post-procedure, subject diary of adverse events and weekly phone calls) 3 weeks
See also
  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 AutoloGel™ 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