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L'Oreal |
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Information provided by: | L'Oreal |
ClinicalTrials.gov Identifier: | NCT00818311 |
Photomodulation is a process which manipulates or regulates cell activity using light sources without thermal effect. Different studies have investigated the use of non-thermal low dose light emitting diode (LED) array for improving the appearance of photo aging damage. The photomodulation concept includes a low energy, narrow band or coherent light with specific pulse sequences and durations.
Preliminary investigations done by McDaniel et al. demonstrated that fibroblast activity could be regulated using pulsing light at specific wavelenghts.
Using a variety of LED light sources, his group has demonstrated that by varying light pulses and other parameters, procollagen synthesis could be upregulated in human skin fibroblast culture [McDaniel DH, et al.Lasers Surg Med. 2002; 14-251]. A clinical correlation was also shown based on different clinical trials data on around 1000 subjects, LED has shown up to 90% improvement in wrinkles and an increase of collagen synthesis versus control with little or no side effects associated [Weiss, RA et al. Lasers Surg Med 2005; 36(2): 85-91- Weiss, RA et al.: J Drugs Dermatol 2004; 3(6): 605-610 - Weiss RA et al. Dermatol Surg 2005; 31(9):1999-1204 - Russel BA et al. J Cosmet Laser Ther 2005; 7 (3-4):196-200 - Bhat J et al. Laser Med Sci 2005; 20(1):6-10]. Based on these promising clinical data, Light BioScience submitted a dossier to the Food and Drug Administration (FDA) and obtained in January 2005 the FDA approval for its GentleWaves® Light Emitting Diode (LED) for the non-invasive treatment of periorbital (eye area) wrinkles and rhytids. The LED technology has been considered by FDA as non significant risk. In Europe, the GentleWaves® Light Emitting Diode has obtained the notified body certification for the same indication. This medical claim is associated with cosmetic improvement of aging and sun-damaged skin, further validation the science of LED photomodulation skin rejuvenation [Investigator's Brochure. Version 1].
This approval has been obtained with a professional LED GentleWaves® device used under a physician's responsibility. The initial regimen of 35 seconds twice per week with at least two days in between treatment for a total of 4 weeks duration of treatment has demonstrated efficacy for the treatment of typical signs of photo aging and no adverse effect. A monocentre, randomized clinical study.
Condition | Intervention |
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Radiation Tolerance Skin Aging Rhytids |
Device: LED GentleWaves® |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | Evaluation of the Effect of Photomodulation on Skin Safety Profile Following Different Schedules of Exposure to the Light Emitting Diode LED (Gentlewaves®) in Randomized Healthy Subjects |
Enrollment: | 100 |
Study Start Date: | June 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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5 |
Device: LED GentleWaves®
primary spectral radiance with a dominant 590 nm wavelength (yellow visible light), irradiance power level of 4mW/cm2, Light pulsed with sequential period on/off for a total duration of 35 seconds per cycle.
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The purpose of this study is to evaluate different treatment regimens in order to be able to develop new indications or to optimize the result already obtained in the treatment of wrinkles around the eyes. We therefore propose to perform a safety clinical trial with male and female volunteers with different schedules per day or per week.
A total of 100 subjects (male and female) will be randomized in the study according to the following schedule of exposure:
Group A: 20 subjects (8 males - 12 females) will be exposed to the LED twice a week for one cycle (35 seconds) with an interval between treatments of at least 2 days, during a treatment period of 4 weeks.
Group B: 20 subjects (8 males - 12 females) will be exposed to the LED twice a week for two consecutive cycles (35 seconds each) with an interval between treatments of at least 2 days, during a treatment period of 4 weeks.
Group C: 20 subjects (8 males - 12 females) will be exposed to the LED for one cycle (35 seconds) twice a day (morning and evening). This treatment will be repeated twice a week with an interval between treatments of at least 2 days, during a treatment period of 4 weeks.
Group D: 20 subjects (8 males - 12 females) will be exposed to the LED for one cycle (35 seconds) every day (from Monday to Friday) during a treatment of period of 4 weeks.
Group E: 20 subjects (8 males - 12 females) will be exposed to the LED for two consecutive cycles (35 seconds each) every day (from Monday to Friday) during a treatment of period of 4 weeks. treatment period of 4 weeks.
Group D: 20 subjects (8 males - 12 females) will be exposed to the LED for one cycle (35 seconds) every day (from Monday to Friday) during a treatment of period of 4 weeks.
Group E: 20 subjects (8 males - 12 females) will be exposed to the LED for two consecutive cycles (35 seconds each) every day (from Monday to Friday) during a treatment of period of 4 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Thomas Stephens and Associates, Inc | |
Carrollton, Texas, United States, 75006 |
Principal Investigator: | James H Herndon, MD | Thomas Stephens and Associates, Inc |
Responsible Party: | Thomas Stephens Associates 3310 Keller Springs Road Suite 130 Carrollton, TX 75006 USA ( Dr Herndon / Dr Stephens ) |
Study ID Numbers: | C08-D-121, 2008/US/LED/003 |
Study First Received: | January 6, 2009 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00818311 History of Changes |
Health Authority: | United States: Institutional Review Board |
Light emitting diode tolerance photomodulation |
Healthy |