Photorejuvenation in the United States

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We have also studied the use of 20% 5-ALA for AKs with the blue light source. This study looked at the role of ALA-PDT for photoaging (Figs. 6.5, 6.6). Recently, others have begun to explore new ways to revise our current mind-

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Fig. 6.5. a Immediately after blue light treatment. b One month after treatment

Fig. 6.4. a Pretreatment. b One week after ALA-PDT treatment. c One month after ALA-PDT treatment

Fig. 6.5. a Immediately after blue light treatment. b One month after treatment set on the proper use of this therapy for pho-toaging and photorejuvenation. Such studies have included the use of broad application of the ALA over the entire area which will be treated, and the use of a variety of lasers and light sources which fit the absorption spectrum of protoporphyrin IX (Fig. 6.1). The light sources which are being studied include a variety of blue light sources, the pulsed dye vascular lasers, and myriad different intense pulsed light (IPL) devices (Table 6.2). In addition, shorter drug incubation times, with the average being 1 h, are now routinely being employed to help make the procedures more accessible to the patients being treated. This means that the patients need only to have therapy on one day versus two consecutive days. In addition, with newer light sources, therapy becomes more tolerable to the patients by potentially lessening the adverse effect profile seen with the original Phase II and Phase III trial patients.

To support the notion of full-face, short-contact ALA therapy, a number of clinical investigators have recently reported their successes with ALA for photorejuvenation. Photorejuvenation utilizing lasers and light sources has been successfully utilized over the past several years to noninvasively rejuvenate the skin, improving facial telangiectasias, pigmentary dyschromias, and overall skin texture. Ruiz-Rodriquez et al. (Ruiz-Rodriquez et al. 2002) found that after 4 h of drug incubation, patients responded well to

Table 6.2. Lasers/light sources currently being used for photorejuvenation with 20% 5-ALA

Blue light sources Blue U (Dusa Pharmaceuticals) ClearLight (CureLight, Lumenis) Pulsed dye vascular lasers V-Star (Cynosure) V-Beam (Candela) Intense pulsed light sources Quantum, Vasculight (Lumenis) Aurora (Syneron)

ClearTouch, SkinStation (Radiancy) Estelux, Medilux (Palomar)

a Before ALA-PDT blue light therapy. b Patient undergoing 4th ALA-PDT blue light therapy

a Before ALA-PDT blue light therapy. b Patient undergoing 4th ALA-PDT blue light therapy

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ALA therapy. In addition, skin quality improvement and a decrease in AKs were noted. Seventeen individuals were studied in this trial with 38 AKs being assessed. Two IPL sessions with ALA applied for 4 h yielded excellent cosmetic results and an 87% improvement in the parameters of photorejuvenation (wrinkling, skin texture, pigmentary changes, and telangiec-tasias). He called this new therapeutic approach "photodynamic photorejuvenation," a term which fully describes the use of ALA-PDT and lasers and light sources. Another study utilized IPL therapy with ALA in 18 individuals with full-face, short-contact therapy. In this study incubation of the ALA was undertaken for 1,2, and 3 h followed by exposure to a blue light source. The investigators found that 1-h drug incubation was as efficacious as the original 14- to 18-h drug incubation time periods. The patients showed improvement in skin sallowness, fine wrinkling, and mottled hyperpigmentation with this therapy. Gold (Gold 2003) reported his experience with full-face, short-contact ALA therapy with IPL in ten patients. IPL settings included the use of a 550-nm cut-off filter, double pulsing with a 3.5-ms pulse delay, and fluence ranges from 20 to 34 J/cm2. The patients in this clinical trial received 3 monthly IPL treatments and had follow-up visits at 1 and 3 months following the last IPL therapy. Results from this clinical trial showed that over 85% of the targeted AKs responded to the therapy. In addition, there was a global skin quality improvement score of greater than 75 % compared to the baseline visits.

Furthermore, there was a 90% improvement in crow's feet, 100% improvement in tactile skin roughness, 90% improvement in mottled hyper-pigmentation, and a 70% improvement in facial erythema. No adverse effects were reported; 30% did have facial erythema and edema reported immediately after therapy which abated within 24-48 h. No patient in this clinical investigation reported any downtime from their day-to-day activities as a result of their therapies. (Figs. 6.7, 6.8). Other investigators (Goldman et al. 2002) evaluated 32 patients with moderate photodamage and multiple AKs, again using full-face, short-contact therapy and the blue light source. At the end of this clinical trial there was a 90% clearance of AKs, a 72% improvement in skin texture, and a 59% improvement in skin pigmentation. Of note, 62.5% of the patients in this trial found this therapy less painful than cryotherapy. Avram and Goldman (Avram and Goldman 2004) reported on 17 individuals using full-face, short-contact ALA therapy and one IPL treatment. They used 1-h drug incubation and found that 68% of the AKs treated responded after the one IPL treatment. In addition, they found that there was a 55% improvement in facial telangiectasias, 48% improvement in pigmentary irregularities, and 25% improvement in skin texture, all with just one PDT treatment.

The pulse dye laser has also been shown to be useful in the photorejuvenation of the skin. By utilizing ALA, Alexiades-Armenakas et al. (Alexiades-Armenakas and Geronemus 2003), evaluated both 3-h and 14- to 18-h drug incuba

Fig. 6.7. a AK before ALA-PDT/IPL therapy. b AK area 1 month after ALA-PDT/IPL therapy
Fig. 6.8. a Crows feet immediately after ALA-PDT/IPL therapy. b Crows feet 1 month after ALA-PDT/IPL therapy

tions. They found both incubation periods successful in treating AKs and in improving the parameters of photorejuvenation. This group utilized a pulsed dye laser at 595 nm, with flu-ence ranges of 4-7.5 J/cm2, 10-ms pulse durations, 10-mm spot size and 30-ms cryogen sprays. They evaluated 2,561 face and scalp AKs with clearances of 99.9% at 10 days, 94.8% at 2 months, and 90.1% at 4 months. Trunk lesions were also evaluated; 54.5% responded at 10 days and 74.4% at 2 months.

Finally, another study has looked at the safety and efficacy of large-surface application of ALA in hairless mice. In this study investigators looked at blue light therapy alone, ALA therapy alone, and the combination of ALA and blue light with weekly applications being performed for 10 months. No tumors were formed during this trial period; therefore ALA-PDT should be deemed not only efficacious but safe as well.

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