Skin Aging Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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