Clinical Applications

12.1.2 Photorejuvenation

LED photomodulation can be used both alone, and in combination with a variety of com­mon nonablative rejuvenation procedures in an office setting. Several antiinflammatory and wound-healing applications have surfaced as well, and these are discussed in the subsequent sections. Treatments are delivered using the Gentlewaves® yellow/IR light LED photomodu­lation unit (LightBioScience, Virginia Beach, VA) with a full-face panel device. Energy density is set at 0.10 Joules/cm2. One hundred pulses are delivered with pulse duration of 250 ms and an off-interval of 100 ms. Treatment time is approximately 35 s.

We have treated over 4000 patients over the last 4 years. Of these treatments, 15% were LED photomodulation alone, and 85% were concomitant with a thermal-based photoreju­venation procedure. Using specific pulsing sequence parameters, which are the basis for the “code” of LED photomodulation, the original multicenter clinical trial was conducted with 90 patients receiving a series of 8 LED treatments over 4 weeks [16-19]. This study showed very favorable results, with over 90% of patients improving by at least one Fitzpat­rick photoaging category, and 65% of the patients demonstrating global improvement in facial texture, fine lines, background erythema, and pigmentation. Results peaked at four to six months following completion of a series of eight treatments [19]. Another study, but this one retrospective, conducted in Baltimore using the same Gentlewaves® 590 nm/870 nm LED array demonstrated similar results (Fig. 12.1). In addition, these results were con­firmed by digital microscopy [20].

Most recently, Gentlewaves® 590 nm LED array was used in an independent clinical laboratory, and these data were confirmed. An additional clinical trial involving 65 subjects used cast impressions of lateral canthus wrinkles (Crow’s feet). These replicas, illuminated by reproducible shadows of light from each wrinkle, were analyzed with the aid of com­mercially available image-analyzing software (Quantirides, Monaderm, Monaco). This analysis showed a significant reduction of the number of wrinkles occurring from the sec­ond to the fourth month after treatment accompanied by a significant reduction of the length of wrinkles at five months posttreatment. Self-assessment by subjects showed a significant improvement of wrinkles, skin textural softness, and skin glow (data on file at L’Oreal, Paris, France).

Others have confirmed that additional wavelengths of LED light, using red and infrared wavelengths, may be effective for improvement in skin texture. Although these treatments were much longer in duration, 36 patients receiving 9 treatments over a 5-week period, showed improvement in skin softness [21]. Each treatment was given in continuous mode (no pulsing) with a treatment time of 20 min using 633 nm and 830 nm as an LED array (Omnilux™, Phototherapeutics, Lake Forest, CA). Another recent report using this system involved 31 subjects with facial rhytids, who received 9 light therapy treatments using combined wavelengths of 633 nm and 830 nm. Fluences were relatively high, utilizing 126 J/cm2 for 633 nm and 66 J/cm2 for 830 nm. Improvements to the skin surface were reported at weeks 9 and 12 by profilometry performed on periorbital casts. Results showed that 52% of subjects showed a 25-50% improvement in photoaging scores [22].

In contrast, the clinical effects of patients who receive Gentlewaves® LED photomodula­tion alone without concomitant treatment report a softening of skin texture, and reduction of roughness and fine lines, which range from significant reduction to subtle but real changes in the “creamy” texture of their complexion. The US FDA first cleared LED devices to be used in the reduction of peri-ocular wrinkles in 2005. Gentlewaves™ was the initial device approved (Fig. 12.2), and then Omnilux™ followed as a 510(k) substantial equivalence approval.