Skin Safety Profile of Different Exposure to the Light Emitting Diode (LED) in Healthy Subjects
Skin Safety Profile of Different Exposure to the Light Emitting Diode (LED) in 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.
Inclusion Criteria:

 -  Healthy subjects (male and female) at least 18 years old with skin types range from
 Fitzpatrick type I-VI (Appendix 1),

 -  Subjects must read, understand and sign the informed consent,

 -  Subjects must be willing and able to comply with follow up requirements,

 -  To be willing to report any medications taken during the study and refrain from taking
 any medication during the study that might produce photoreactions.

 Exclusion Criteria:

 -  Subjects must not have active or localized or systemic infection,

 -  Subjects must not be immunocompromised,

 -  Subjects must be negative for HIV and hepatitis B and C serology,

 -  Subjects must not have history of light activated seizure or migraine headache
 disorder,

 -  Individuals taking medication who have been advised by a physician or pharmacist to
 avoid sunlight and subjects having vitiligo

 -  Subjects must not have mental illness such as schizophrenia or severe depression,

 -  Subjects must not have photosensitivity, photoallergy or photodermatitis,

 -  Subjects must not be pregnant or breast feeding. Subjects must discuss concerns about
 birth control with the study physician. Subjects who become pregnant during the study
 must inform the investigator immediately,

 -  Subject must not have a skin condition that the examining Investigator deems
 inappropriate for participation,

 -  Subject must not take part or intend to take part in another study liable to interfere
 with this study whatever the region of the body considered for 30 days prior to the
 study start and 30 days following completion of the study,

 -  Subjects must not have had GentleWaves treatment, other light treatments (including
 tanning beds), collagen or other facial tissue augmentation, Botox®, chemical peels,
 non-ablative (non invasive laser) therapies, dermabrasion, topical antioxidant or
 other resurfacing procedures at any time during the study,

 -  Subject must not refuse to sign the informed consent document and/or refuse to comply
 with all study requirements,

 -  Subjects must not have any previous history of keloïd scarring.